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On Oct. 1, 2024, the FDA began implementing a reorganization impacting many parts of the agency. We are in the process of updating FDA.gov content to reflect these changes.

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  5. List of Affected Prescription Acetaminophen Manufacturers
  1. Information by Drug Class

List of Affected Prescription Acetaminophen Manufacturers

NDC# - National Drug Code Number
NDA# - New Drug Application Number
ANDA# - Abbreviated New Drug Application Number

 

PRODUCT (ACTIVE INGREDIENT) DOSAGE TYPE SPONSOR NDA #
ANDA #		 NDC #
TALACEN (APAP; PENTAZOCINE) TABLET SANOFI AVENTIS 18458 00024-1937-04
FIORICET W/ CODEINE (APAP; BUTALBITAL; CAFFEINE; CODEINE) CAPSULE WATSON 20232 52544-0958-01
ULTRACET (APAP; TRAMADOL) TABLET ORTHO MCNEIL JANSSEN 21123 00045-0650-60
ACETAMINOPHEN; BUTALBITAL CAPSULE; ORAL VALEANT 88831  
  TABLET; ORAL MIKART 89987  
  TABLET; ORAL MIKART 89988  
  TABLET; ORAL VALEANT 87811  
ACETAMINOPHEN; BUTALBITAL; CAFFEINE CAPSULE; ORAL MIKART 89007  
  CAPSULE; ORAL NEXGEN PHARMA 40885  
  CAPSULE; ORAL WEST WARD 40261  
  CAPSULE; ORAL MIKART 40085  
  SOLUTION; ORAL MIKART 40387  
  TABLET; ORAL CONCORD LABS NJ 40864  
  TABLET; ORAL CONCORD LABS NJ 40883  
  TABLET; ORAL MALLINCKRODT 87804  
  TABLET; ORAL MIKART 89175  
  TABLET; ORAL MIKART 40496  
  TABLET; ORAL VINTAGE PHARMS 40511  
  TABLET; ORAL VINTAGE PHARMS 40513  
  TABLET; ORAL WATSON LABS 40267  
  TABLET; ORAL WEST WARD 89718  
  TABLET; ORAL WEST WARD 40336  
  TABLET; ORAL MIKART 89451  
  TABLET; ORAL WATSON LABS 88616  
ACETAMINOPHEN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE CAPSULE; ORAL NEXGEN PHARMA INC 76560  
  CAPSULE; ORAL VINTAGE PHARMS 75929  
  CAPSULE; ORAL WEST WARD 75618  
  CAPSULE; ORAL VALEANT 74911  
ACETAMINOPHEN; CAFFEINE; DIHYDROCODEINE BITARTRATE CAPSULE; ORAL E5 PHARMA INC 40688  
  CAPSULE; ORAL MIKART 40109  
  TABLET; ORAL BOCA PHARMA 40701  
  TABLET; ORAL MIKART 40316  
  TABLET; ORAL WEST WARD 40637  
ACETAMINOPHEN; CODEINE PHOSPHATE SOLUTION; ORAL ACTAVIS MID ATLANTIC 85861  
  SOLUTION; ORAL HI TECH PHARMA 40119  
  SOLUTION; ORAL MIKART 89450  
  SOLUTION; ORAL MORTON GROVE 87006  
  SOLUTION; ORAL PHARM ASSOC 87508  
  SUSPENSION; ORAL ACTAVIS MID ATLANTIC 85883  
  SUSPENSION; ORAL VALEANT 86024  
  TABLET; ORAL AMNEAL PHARMS NY 40779  
  TABLET; ORAL DURAMED PHARMS BARR 40223  
  TABLET; ORAL MALLINCKRODT 40419  
  TABLET; ORAL MIKART 89238  
  TABLET; ORAL MIKART 89231  
  TABLET; ORAL MIKART 89363  
  TABLET; ORAL RANBAXY 85868  
  TABLET; ORAL RANBAXY 87083  
  TABLET; ORAL TEVA 88627  
  TABLET; ORAL TEVA 88628  
  TABLET; ORAL TEVA 88629  
  TABLET; ORAL VINTAGE 89990  
  TABLET; ORAL VINTAGE 89805  
  TABLET; ORAL VINTAGE PHARMS 89828  
  TABLET; ORAL WATSON LABS 89997  
  TABLET; ORAL WATSON LABS 89998  
  TABLET; ORAL WATSON LABS 89999  
  TABLET; ORAL WATSON LABS FLORIDA 40443  
  TABLET; ORAL ORTHO MCNEIL JANSSEN 85055  
ACETAMINOPHEN; HYDROCODONE BITARTRATE CAPSULE; ORAL MIKART 81067  
  CAPSULE; ORAL MIKART 89008  
  SOLUTION; ORAL KV PHARM 40366  
  SOLUTION; ORAL MALLINCKRODT 40418  
  SOLUTION; ORAL MALLINCKRODT 40508  
  SOLUTION; ORAL MIKART 81051  
  SOLUTION; ORAL MIKART 40881  
  SOLUTION; ORAL MIKART 40482  
  SOLUTION; ORAL PHARM ASSOC 40182  
  SOLUTION; ORAL PHARM ASSOC 40834  
  SOLUTION; ORAL VINTAGE 40520  
  TABLET; ORAL MALLINCKRODT 89160  
  TABLET; ORAL MALLINCKRODT 40468  
  TABLET; ORAL MALLINCKRODT 40409  
  TABLET; ORAL MALLINCKRODT 40405  
  TABLET; ORAL MALLINCKRODT 89725  
  TABLET; ORAL SCHWARZ PHARMA 87757  
  TABLET; ORAL AMNEAL PHARMS NY 40736  
  TABLET; ORAL AMNEAL PHARMS NY 40746  
  TABLET; ORAL AMNEAL PHARMS NY 40729  
  TABLET; ORAL AMNEAL PHARMS NY 40748  
  TABLET; ORAL AMNEAL PHARMS NY 40813  
  TABLET; ORAL AMNEAL PHARMS NY 40754  
  TABLET; ORAL AMNEAL PHARMS NY 40757  
  TABLET; ORAL AMNEAL PHARMS NY 40769  
  TABLET; ORAL MALLINCKRODT 40400  
  TABLET; ORAL MALLINCKRODT 40084  
  TABLET; ORAL MALLINCKRODT 40201  
  TABLET; ORAL MALLINCKRODT 40201  
  TABLET; ORAL MALLINCKRODT 40084  
  TABLET; ORAL MALLINCKRODT 40084  
  TABLET; ORAL MALLINCKRODT 40084  
  TABLET; ORAL MIKART 40432  
  TABLET; ORAL MIKART 89698  
  TABLET; ORAL MIKART 89699  
  TABLET; ORAL MIKART 89689  
  TABLET; ORAL MIKART 81223  
  TABLET; ORAL MIKART 40658  
  TABLET; ORAL MIKART 40556  
  TABLET; ORAL MIKART 40556  
  TABLET; ORAL RANBAXY 40826  
  TABLET; ORAL RANBAXY 40825  
  TABLET; ORAL RANBAXY 40824  
  TABLET; ORAL RANBAXY 40822  
  TABLET; ORAL SANDOZ 40149  
  TABLET; ORAL SANDOZ 40149  
  TABLET; ORAL SUN PHARM INDS INC 90118  
  TABLET; ORAL SUN PHARM INDS INC 90118  
  TABLET; ORAL SUN PHARM INDS INC 90118  
  TABLET; ORAL SUN PHARM INDS INC 90265  
  TABLET; ORAL SUN PHARM INDS INC 90265  
  TABLET; ORAL SUN PHARM INDS INC 90265  
  TABLET; ORAL SUN PHARM INDS INC 90380  
  TABLET; ORAL SUN PHARM INDS INC 90380  
  TABLET; ORAL SUN PHARM INDS INC 90380  
  TABLET; ORAL SUN PHARM INDS INC 90380  
  TABLET; ORAL VINTAGE PHARMS 40655  
  TABLET; ORAL VINTAGE PHARMS 40656  
  TABLET; ORAL VINTAGE PHARMS 40355  
  TABLET; ORAL VINTAGE PHARMS 40144  
  TABLET; ORAL VINTAGE PHARMS 89971  
  TABLET; ORAL VINTAGE PHARMS 40144  
  TABLET; ORAL VINTAGE PHARMS 40356  
  TABLET; ORAL VINTAGE PHARMS 40155  
  TABLET; ORAL VINTAGE PHARMS 40143  
  TABLET; ORAL VINTAGE PHARMS 40358  
  TABLET; ORAL VINTAGE PHARMS 40157  
  TABLET; ORAL WATSON LABS 40248  
  TABLET; ORAL WATSON LABS 81079  
  TABLET; ORAL WATSON LABS 40123  
  TABLET; ORAL WATSON LABS 89883  
  TABLET; ORAL WATSON LABS 81080  
  TABLET; ORAL WATSON LABS 40123  
  TABLET; ORAL WATSON LABS 40148  
  TABLET; ORAL WATSON LABS 40094  
  TABLET; ORAL WATSON LABS 40123  
  TABLET; ORAL WATSON LABS 40123  
  TABLET; ORAL WATSON LABS 40094  
  TABLET; ORAL WATSON LABS 40094  
  TABLET; ORAL WATSON LABS 81083  
  TABLET; ORAL WATSON LABS 40094  
  TABLET; ORAL WATSON LABS 40493  
  TABLET; ORAL WATSON LABS 40495  
  TABLET; ORAL WATSON LABS 40494  
  TABLET; ORAL MALLINCKRODT 87722  
  TABLET; ORAL UCB INC 40100  
  TABLET; ORAL WATSON LABS 40099  
  TABLET; ORAL WATSON LABS 40148  
  TABLET; ORAL ABBOTT 88058  
  TABLET; ORAL ABBOTT 89736  
  TABLET; ORAL ABBOTT 40117  
  TABLET; ORAL ENDO PHARMS 40288  
  TABLET; ORAL ENDO PHARMS 40288  
  TABLET; ORAL ENDO PHARMS 40288  
ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE CAPSULE; ORAL ACTAVIS TOTOWA 40199  
  CAPSULE; ORAL DURAMED PHARMS BARR 40289  
  CAPSULE; ORAL ENDO PHARMS 40303  
  CAPSULE; ORAL MALLINCKRODT 40257  
  CAPSULE; ORAL VINTAGE PHARMS 40106  
  CAPSULE; ORAL WATSON LABS 40234  
  CAPSULE; ORAL ROXANE 40061  
  CAPSULE; ORAL ORTHO MCNEIL JANSSEN 88790  
  SOLUTION; ORAL MALLINCKRODT 40680  
  SOLUTION; ORAL ROXANE 89351  
  TABLET; ORAL MALLINCKRODT 87463  
  TABLET; ORAL ACTAVIS TOTOWA 40203  
  TABLET; ORAL AMNEAL PHARMS NY 40777  
  TABLET; ORAL AMNEAL PHARMS NY 40778  
  TABLET; ORAL AMNEAL PHARMS NY 40789  
  TABLET; ORAL AMNEAL PHARMS NY 40789  
  TABLET; ORAL COASTAL PHARMS 90177  
  TABLET; ORAL COASTAL PHARMS 90177  
  TABLET; ORAL COASTAL PHARMS 90177  
  TABLET; ORAL COASTAL PHARMS 90177  
  TABLET; ORAL COASTAL PHARMS 90177  
  TABLET; ORAL COASTAL PHARMS 90177  
  TABLET; ORAL MALLINCKRODT 40545  
  TABLET; ORAL MALLINCKRODT 40545  
  TABLET; ORAL MALLINCKRODT 40550  
  TABLET; ORAL MALLINCKRODT 40550  
  TABLET; ORAL MIKART 40608  
  TABLET; ORAL MIKART 40608  
  TABLET; ORAL MIKART 40608  
  TABLET; ORAL MIKART 40608  
  TABLET; ORAL MIKART 40679  
  TABLET; ORAL MIKART 40687  
  TABLET; ORAL MIKART 40698  
  TABLET; ORAL MIKART 40692  
  TABLET; ORAL MIKART 40676  
  TABLET; ORAL VINTAGE PHARMS 40105  
  TABLET; ORAL WATSON LABS 40171  
  TABLET; ORAL WATSON LABS 40535  
  TABLET; ORAL WATSON LABS 40535  
  TABLET; ORAL WATSON LABS 40371  
  TABLET; ORAL WATSON LABS 40371  
  TABLET; ORAL ENDO PHARMS 40330  
  TABLET; ORAL ENDO PHARMS 40330  
  TABLET; ORAL ENDO PHARMS 40434  
  TABLET; ORAL ENDO PHARMS 40434  
  TABLET; ORAL ENDO PHARMS 40341  
  TABLET; ORAL ENDO PHARMS 40341  
  TABLET; ORAL ROXANE 87003  
  TABLET; ORAL ROXANE 89775  
ACETAMINOPHEN; PENTAZOCINE HYDROCHLORIDE TABLET; ORAL GAVIS 76202  
  TABLET; ORAL WATSON LABS 74699  
ACETAMINOPHEN; PROPOXYPHENE HYDROCHLORIDE TABLET; ORAL MYLAN 83978  
  TABLET; ORAL VINTAGE PHARMS 40507  
ACETAMINOPHEN; PROPOXYPHENE NAPSYLATE TABLET; ORAL XANODYNE PHARM 76429  
  TABLET; ORAL XANODYNE PHARM 17122  
  TABLET; ORAL CONCORD LABS NJ 77821  
  TABLET; ORAL CORNERSTONE 76750  
  TABLET; ORAL CORNERSTONE 76743  
  TABLET; ORAL MYLAN 70145  
  TABLET; ORAL TEVA 74119  
  TABLET; ORAL VINTAGE PHARMS 74843  
  TABLET; ORAL WOCKHARDT 77677  
ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE TABLET; ORAL AMNEAL PHARMS 90485  
  TABLET; ORAL CARACO 77184  
  TABLET; ORAL KALI LABS 76475  
  TABLET; ORAL MYLAN 77858  
  TABLET; ORAL WATSON LABS 76914  
  TABLET; ORAL ORTHO MCNEIL JANSSEN 21123  
         
         
DISCN PRODUCT LIST        
         
ACETAMINOPHEN SUPPOSITORY; RECTAL G AND W LABS 72218  
ACETAMINOPHEN; ASPIRIN; CODEINE PHOSPHATE CAPSULE; ORAL SCHERER LABS 85640  
  CAPSULE; ORAL SCHERER LABS 85639  
  CAPSULE; ORAL SCHERER LABS 85638  
ACETAMINOPHEN; BUTALBITAL CAPSULE; ORAL MALLINCKRODT 88991  
  CAPSULE; ORAL MALLINCKRODT 89405  
ACETAMINOPHEN; BUTALBITAL; CAFFEINE TABLET; ORAL MUTUAL PHARM 40601  
  TABLET; ORAL WATSON LABS 89536  
ACETAMINOPHEN; CAFFEINE; DIHYDROCODEINE BITARTRATE CAPSULE; ORAL LEITNER PHARMS 89166  
  TABLET; ORAL EVERYLIFE 85217  
  TABLET; ORAL MIKART 89244  
  TABLET; ORAL MUTUAL PHARM 89671  
  TABLET; ORAL MUTUAL PHARM 85795  
  TABLET; ORAL MUTUAL PHARM 89672  
  TABLET; ORAL MUTUAL PHARM 85794  
  TABLET; ORAL MUTUAL PHARM 87653  
  TABLET; ORAL MUTUAL PHARM 89673  
  TABLET; ORAL PHARMERAL 87762  
  TABLET; ORAL SANDOZ 87433  
  TABLET; ORAL SANDOZ 81250  
  TABLET; ORAL SANDOZ 85917  
  TABLET; ORAL SANDOZ 81249  
  TABLET; ORAL SANDOZ 87423  
  TABLET; ORAL CARNRICK 83643  
  TABLET; ORAL WATSON LABS FLORIDA 40447  
  TABLET; ORAL WATSON LABS FLORIDA 40441  
  TABLET; ORAL ORTHO MCNEIL JANSSEN 85055  
ACETAMINOPHEN; HYDROCODONE BITARTRATE CAPSULE; ORAL CENT PHARMS 88898  
  CAPSULE; ORAL IVAX PHARMS 89907  
  CAPSULE; ORAL MALLINCKRODT 88956  
  CAPSULE; ORAL MALLINCKRODT 89006  
  CAPSULE; ORAL MIKART 81070  
  CAPSULE; ORAL MIKART 81069  
  CAPSULE; ORAL MIKART 81068  
  CAPSULE; ORAL MALLINCKRODT 87336  
  SOLUTION; ORAL MIKART 89557  
  TABLET; ORAL BARR 40307  
  TABLET; ORAL BARR 40308  
  TABLET; ORAL BARR 40309  
  TABLET; ORAL ENDO PHARMS 40281  
  TABLET; ORAL ENDO PHARMS 40280  
  TABLET; ORAL IVAX PHARMS 89696  
  TABLET; ORAL MIKART 89697  
  TABLET; ORAL MIKART 89271  
  TABLET; ORAL MUTUAL PHARM 40240  
  TABLET; ORAL MUTUAL PHARM 40236  
  TABLET; ORAL VINTAGE PHARMS 89831  
  TABLET; ORAL WATSON LABS 40248  
  TABLET; ORAL WATSON LABS 40122  
ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE CAPSULE; ORAL BARR 40304  
  CAPSULE; ORAL MUTUAL PHARM 40219  
  TABLET; ORAL BARR 87406  
  TABLET; ORAL DURAMED PHARMS BARR 40272  
  TABLET; ORAL ENDO PHARMS 85106  
ACETAMINOPHEN; PROPOXYPHENE HYDROCHLORIDE TABLET; ORAL MYLAN 83689  
  TABLET; ORAL SANDOZ 89959  
  TABLET; ORAL WATSON LABS 40139  
  TABLET; ORAL LEITNER PHARMS 84999  
ACETAMINOPHEN; PROPOXYPHENE NAPSYLATE TABLET; ORAL ACTAVIS ELIZABETH 70910  
  TABLET; ORAL IVAX SUB TEVA PHARMS 70146  
  TABLET; ORAL MALLINCKRODT 75738  
  TABLET; ORAL MUTUAL PHARM 70115  
  TABLET; ORAL MUTUAL PHARM 70615  
  TABLET; ORAL MUTUAL PHARM 70771  
  TABLET; ORAL MUTUAL PHARM 70775  
  TABLET; ORAL MUTUAL PHARM 70116  
  TABLET; ORAL MYLAN 72195  
  TABLET; ORAL SANDOZ 70443  
  TABLET; ORAL WATSON LABS FLORIDA 77196  
  TABLET; ORAL WATSON LABS FLORIDA 76609  

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