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U.S. Department of Health and Human Services

Drugs

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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 TYPESPONSORNDA #
ANDA #
NDC #
TALACEN (APAP; PENTAZOCINE)TABLETSANOFI AVENTIS1845800024-1937-04
FIORICET W/ CODEINE (APAP; BUTALBITAL; CAFFEINE; CODEINE)CAPSULEWATSON2023252544-0958-01
ULTRACET (APAP; TRAMADOL)TABLETORTHO MCNEIL JANSSEN2112300045-0650-60
ACETAMINOPHEN; BUTALBITALCAPSULE; ORALVALEANT88831 
 TABLET; ORALMIKART89987 
 TABLET; ORALMIKART89988 
 TABLET; ORALVALEANT87811 
ACETAMINOPHEN; BUTALBITAL; CAFFEINECAPSULE; ORALMIKART89007 
 CAPSULE; ORALNEXGEN PHARMA40885 
 CAPSULE; ORALWEST WARD40261 
 CAPSULE; ORALMIKART40085 
 SOLUTION; ORALMIKART40387 
 TABLET; ORALCONCORD LABS NJ40864 
 TABLET; ORALCONCORD LABS NJ40883 
 TABLET; ORALMALLINCKRODT87804 
 TABLET; ORALMIKART89175 
 TABLET; ORALMIKART40496 
 TABLET; ORALVINTAGE PHARMS40511 
 TABLET; ORALVINTAGE PHARMS40513 
 TABLET; ORALWATSON LABS40267 
 TABLET; ORALWEST WARD89718 
 TABLET; ORALWEST WARD40336 
 TABLET; ORALMIKART89451 
 TABLET; ORALWATSON LABS88616 
ACETAMINOPHEN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATECAPSULE; ORALNEXGEN PHARMA INC76560 
 CAPSULE; ORALVINTAGE PHARMS75929 
 CAPSULE; ORALWEST WARD75618 
 CAPSULE; ORALVALEANT74911 
ACETAMINOPHEN; CAFFEINE; DIHYDROCODEINE BITARTRATECAPSULE; ORALE5 PHARMA INC40688 
 CAPSULE; ORALMIKART40109 
 TABLET; ORALBOCA PHARMA40701 
 TABLET; ORALMIKART40316 
 TABLET; ORALWEST WARD40637 
ACETAMINOPHEN; CODEINE PHOSPHATESOLUTION; ORALACTAVIS MID ATLANTIC85861 
 SOLUTION; ORALHI TECH PHARMA40119 
 SOLUTION; ORALMIKART89450 
 SOLUTION; ORALMORTON GROVE87006 
 SOLUTION; ORALPHARM ASSOC87508 
 SUSPENSION; ORALACTAVIS MID ATLANTIC85883 
 SUSPENSION; ORALVALEANT86024 
 TABLET; ORALAMNEAL PHARMS NY40779 
 TABLET; ORALDURAMED PHARMS BARR40223 
 TABLET; ORALMALLINCKRODT40419 
 TABLET; ORALMIKART89238 
 TABLET; ORALMIKART89231 
 TABLET; ORALMIKART89363 
 TABLET; ORALRANBAXY85868 
 TABLET; ORALRANBAXY87083 
 TABLET; ORALTEVA88627 
 TABLET; ORALTEVA88628 
 TABLET; ORALTEVA88629 
 TABLET; ORALVINTAGE89990 
 TABLET; ORALVINTAGE89805 
 TABLET; ORALVINTAGE PHARMS89828 
 TABLET; ORALWATSON LABS89997 
 TABLET; ORALWATSON LABS89998 
 TABLET; ORALWATSON LABS89999 
 TABLET; ORALWATSON LABS FLORIDA40443 
 TABLET; ORALORTHO MCNEIL JANSSEN85055 
ACETAMINOPHEN; HYDROCODONE BITARTRATECAPSULE; ORALMIKART81067 
 CAPSULE; ORALMIKART89008 
 SOLUTION; ORALKV PHARM40366 
 SOLUTION; ORALMALLINCKRODT40418 
 SOLUTION; ORALMALLINCKRODT40508 
 SOLUTION; ORALMIKART81051 
 SOLUTION; ORALMIKART40881 
 SOLUTION; ORALMIKART40482 
 SOLUTION; ORALPHARM ASSOC40182 
 SOLUTION; ORALPHARM ASSOC40834 
 SOLUTION; ORALVINTAGE40520 
 TABLET; ORALMALLINCKRODT89160 
 TABLET; ORALMALLINCKRODT40468 
 TABLET; ORALMALLINCKRODT40409 
 TABLET; ORALMALLINCKRODT40405 
 TABLET; ORALMALLINCKRODT89725 
 TABLET; ORALSCHWARZ PHARMA87757 
 TABLET; ORALAMNEAL PHARMS NY40736 
 TABLET; ORALAMNEAL PHARMS NY40746 
 TABLET; ORALAMNEAL PHARMS NY40729 
 TABLET; ORALAMNEAL PHARMS NY40748 
 TABLET; ORALAMNEAL PHARMS NY40813 
 TABLET; ORALAMNEAL PHARMS NY40754 
 TABLET; ORALAMNEAL PHARMS NY40757 
 TABLET; ORALAMNEAL PHARMS NY40769 
 TABLET; ORALMALLINCKRODT40400 
 TABLET; ORALMALLINCKRODT40084 
 TABLET; ORALMALLINCKRODT40201 
 TABLET; ORALMALLINCKRODT40201 
 TABLET; ORALMALLINCKRODT40084 
 TABLET; ORALMALLINCKRODT40084 
 TABLET; ORALMALLINCKRODT40084 
 TABLET; ORALMIKART40432 
 TABLET; ORALMIKART89698 
 TABLET; ORALMIKART89699 
 TABLET; ORALMIKART89689 
 TABLET; ORALMIKART81223 
 TABLET; ORALMIKART40658 
 TABLET; ORALMIKART40556 
 TABLET; ORALMIKART40556 
 TABLET; ORALRANBAXY40826 
 TABLET; ORALRANBAXY40825 
 TABLET; ORALRANBAXY40824 
 TABLET; ORALRANBAXY40822 
 TABLET; ORALSANDOZ40149 
 TABLET; ORALSANDOZ40149 
 TABLET; ORALSUN PHARM INDS INC90118 
 TABLET; ORALSUN PHARM INDS INC90118 
 TABLET; ORALSUN PHARM INDS INC90118 
 TABLET; ORALSUN PHARM INDS INC90265 
 TABLET; ORALSUN PHARM INDS INC90265 
 TABLET; ORALSUN PHARM INDS INC90265 
 TABLET; ORALSUN PHARM INDS INC90380 
 TABLET; ORALSUN PHARM INDS INC90380 
 TABLET; ORALSUN PHARM INDS INC90380 
 TABLET; ORALSUN PHARM INDS INC90380 
 TABLET; ORALVINTAGE PHARMS40655 
 TABLET; ORALVINTAGE PHARMS40656 
 TABLET; ORALVINTAGE PHARMS40355 
 TABLET; ORALVINTAGE PHARMS40144 
 TABLET; ORALVINTAGE PHARMS89971 
 TABLET; ORALVINTAGE PHARMS40144 
 TABLET; ORALVINTAGE PHARMS40356 
 TABLET; ORALVINTAGE PHARMS40155 
 TABLET; ORALVINTAGE PHARMS40143 
 TABLET; ORALVINTAGE PHARMS40358 
 TABLET; ORALVINTAGE PHARMS40157 
 TABLET; ORALWATSON LABS40248 
 TABLET; ORALWATSON LABS81079 
 TABLET; ORALWATSON LABS40123 
 TABLET; ORALWATSON LABS89883 
 TABLET; ORALWATSON LABS81080 
 TABLET; ORALWATSON LABS40123 
 TABLET; ORALWATSON LABS40148 
 TABLET; ORALWATSON LABS40094 
 TABLET; ORALWATSON LABS40123 
 TABLET; ORALWATSON LABS40123 
 TABLET; ORALWATSON LABS40094 
 TABLET; ORALWATSON LABS40094 
 TABLET; ORALWATSON LABS81083 
 TABLET; ORALWATSON LABS40094 
 TABLET; ORALWATSON LABS40493 
 TABLET; ORALWATSON LABS40495 
 TABLET; ORALWATSON LABS40494 
 TABLET; ORALMALLINCKRODT87722 
 TABLET; ORALUCB INC40100 
 TABLET; ORALWATSON LABS40099 
 TABLET; ORALWATSON LABS40148 
 TABLET; ORALABBOTT88058 
 TABLET; ORALABBOTT89736 
 TABLET; ORALABBOTT40117 
 TABLET; ORALENDO PHARMS40288 
 TABLET; ORALENDO PHARMS40288 
 TABLET; ORALENDO PHARMS40288 
ACETAMINOPHEN; OXYCODONE HYDROCHLORIDECAPSULE; ORALACTAVIS TOTOWA40199 
 CAPSULE; ORALDURAMED PHARMS BARR40289 
 CAPSULE; ORALENDO PHARMS40303 
 CAPSULE; ORALMALLINCKRODT40257 
 CAPSULE; ORALVINTAGE PHARMS40106 
 CAPSULE; ORALWATSON LABS40234 
 CAPSULE; ORALROXANE40061 
 CAPSULE; ORALORTHO MCNEIL JANSSEN88790 
 SOLUTION; ORALMALLINCKRODT40680 
 SOLUTION; ORALROXANE89351 
 TABLET; ORALMALLINCKRODT87463 
 TABLET; ORALACTAVIS TOTOWA40203 
 TABLET; ORALAMNEAL PHARMS NY40777 
 TABLET; ORALAMNEAL PHARMS NY40778 
 TABLET; ORALAMNEAL PHARMS NY40789 
 TABLET; ORALAMNEAL PHARMS NY40789 
 TABLET; ORALCOASTAL PHARMS90177 
 TABLET; ORALCOASTAL PHARMS90177 
 TABLET; ORALCOASTAL PHARMS90177 
 TABLET; ORALCOASTAL PHARMS90177 
 TABLET; ORALCOASTAL PHARMS90177 
 TABLET; ORALCOASTAL PHARMS90177 
 TABLET; ORALMALLINCKRODT40545 
 TABLET; ORALMALLINCKRODT40545 
 TABLET; ORALMALLINCKRODT40550 
 TABLET; ORALMALLINCKRODT40550 
 TABLET; ORALMIKART40608 
 TABLET; ORALMIKART40608 
 TABLET; ORALMIKART40608 
 TABLET; ORALMIKART40608 
 TABLET; ORALMIKART40679 
 TABLET; ORALMIKART40687 
 TABLET; ORALMIKART40698 
 TABLET; ORALMIKART40692 
 TABLET; ORALMIKART40676 
 TABLET; ORALVINTAGE PHARMS40105 
 TABLET; ORALWATSON LABS40171 
 TABLET; ORALWATSON LABS40535 
 TABLET; ORALWATSON LABS40535 
 TABLET; ORALWATSON LABS40371 
 TABLET; ORALWATSON LABS40371 
 TABLET; ORALENDO PHARMS40330 
 TABLET; ORALENDO PHARMS40330 
 TABLET; ORALENDO PHARMS40434 
 TABLET; ORALENDO PHARMS40434 
 TABLET; ORALENDO PHARMS40341 
 TABLET; ORALENDO PHARMS40341 
 TABLET; ORALROXANE87003 
 TABLET; ORALROXANE89775 
ACETAMINOPHEN; PENTAZOCINE HYDROCHLORIDETABLET; ORALGAVIS76202 
 TABLET; ORALWATSON LABS74699 
ACETAMINOPHEN; PROPOXYPHENE HYDROCHLORIDETABLET; ORALMYLAN83978 
 TABLET; ORALVINTAGE PHARMS40507 
ACETAMINOPHEN; PROPOXYPHENE NAPSYLATETABLET; ORALXANODYNE PHARM76429 
 TABLET; ORALXANODYNE PHARM17122 
 TABLET; ORALCONCORD LABS NJ77821 
 TABLET; ORALCORNERSTONE76750 
 TABLET; ORALCORNERSTONE76743 
 TABLET; ORALMYLAN70145 
 TABLET; ORALTEVA74119 
 TABLET; ORALVINTAGE PHARMS74843 
 TABLET; ORALWOCKHARDT77677 
ACETAMINOPHEN; TRAMADOL HYDROCHLORIDETABLET; ORALAMNEAL PHARMS90485 
 TABLET; ORALCARACO77184 
 TABLET; ORALKALI LABS76475 
 TABLET; ORALMYLAN77858 
 TABLET; ORALWATSON LABS76914 
 TABLET; ORALORTHO MCNEIL JANSSEN21123 
     
     
DISCN PRODUCT LIST    
     
ACETAMINOPHENSUPPOSITORY; RECTALG AND W LABS72218 
ACETAMINOPHEN; ASPIRIN; CODEINE PHOSPHATECAPSULE; ORALSCHERER LABS85640 
 CAPSULE; ORALSCHERER LABS85639 
 CAPSULE; ORALSCHERER LABS85638 
ACETAMINOPHEN; BUTALBITALCAPSULE; ORALMALLINCKRODT88991 
 CAPSULE; ORALMALLINCKRODT89405 
ACETAMINOPHEN; BUTALBITAL; CAFFEINETABLET; ORALMUTUAL PHARM40601 
 TABLET; ORALWATSON LABS89536 
ACETAMINOPHEN; CAFFEINE; DIHYDROCODEINE BITARTRATECAPSULE; ORALLEITNER PHARMS89166 
 TABLET; ORALEVERYLIFE85217 
 TABLET; ORALMIKART89244 
 TABLET; ORALMUTUAL PHARM89671 
 TABLET; ORALMUTUAL PHARM85795 
 TABLET; ORALMUTUAL PHARM89672 
 TABLET; ORALMUTUAL PHARM85794 
 TABLET; ORALMUTUAL PHARM87653 
 TABLET; ORALMUTUAL PHARM89673 
 TABLET; ORALPHARMERAL87762 
 TABLET; ORALSANDOZ87433 
 TABLET; ORALSANDOZ81250 
 TABLET; ORALSANDOZ85917 
 TABLET; ORALSANDOZ81249 
 TABLET; ORALSANDOZ87423 
 TABLET; ORALCARNRICK83643 
 TABLET; ORALWATSON LABS FLORIDA40447 
 TABLET; ORALWATSON LABS FLORIDA40441 
 TABLET; ORALORTHO MCNEIL JANSSEN85055 
ACETAMINOPHEN; HYDROCODONE BITARTRATECAPSULE; ORALCENT PHARMS88898 
 CAPSULE; ORALIVAX PHARMS89907 
 CAPSULE; ORALMALLINCKRODT88956 
 CAPSULE; ORALMALLINCKRODT89006 
 CAPSULE; ORALMIKART81070 
 CAPSULE; ORALMIKART81069 
 CAPSULE; ORALMIKART81068 
 CAPSULE; ORALMALLINCKRODT87336 
 SOLUTION; ORALMIKART89557 
 TABLET; ORALBARR40307 
 TABLET; ORALBARR40308 
 TABLET; ORALBARR40309 
 TABLET; ORALENDO PHARMS40281 
 TABLET; ORALENDO PHARMS40280 
 TABLET; ORALIVAX PHARMS89696 
 TABLET; ORALMIKART89697 
 TABLET; ORALMIKART89271 
 TABLET; ORALMUTUAL PHARM40240 
 TABLET; ORALMUTUAL PHARM40236 
 TABLET; ORALVINTAGE PHARMS89831 
 TABLET; ORALWATSON LABS40248 
 TABLET; ORALWATSON LABS40122 
ACETAMINOPHEN; OXYCODONE HYDROCHLORIDECAPSULE; ORALBARR40304 
 CAPSULE; ORALMUTUAL PHARM40219 
 TABLET; ORALBARR87406 
 TABLET; ORALDURAMED PHARMS BARR40272 
 TABLET; ORALENDO PHARMS85106 
ACETAMINOPHEN; PROPOXYPHENE HYDROCHLORIDETABLET; ORALMYLAN83689 
 TABLET; ORALSANDOZ89959 
 TABLET; ORALWATSON LABS40139 
 TABLET; ORALLEITNER PHARMS84999 
ACETAMINOPHEN; PROPOXYPHENE NAPSYLATETABLET; ORALACTAVIS ELIZABETH70910 
 TABLET; ORALIVAX SUB TEVA PHARMS70146 
 TABLET; ORALMALLINCKRODT75738 
 TABLET; ORALMUTUAL PHARM70115 
 TABLET; ORALMUTUAL PHARM70615 
 TABLET; ORALMUTUAL PHARM70771 
 TABLET; ORALMUTUAL PHARM70775 
 TABLET; ORALMUTUAL PHARM70116 
 TABLET; ORALMYLAN72195 
 TABLET; ORALSANDOZ70443 
 TABLET; ORALWATSON LABS FLORIDA77196 
 TABLET; ORALWATSON LABS FLORIDA76609 

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