FDA.reportPublic FDA data

NDC 00591-0385 - HYDROCODONE BITARTRATE AND ACETAMINOPHEN

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
00591-0385
Manufacturer
Keltman Pharmaceuticals Inc.
Effective date
2010-12-10
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
hydrocodone bitartrate and acetaminophen tabletKeltman Pharmaceuticals Inc.2010-12-10HUMAN PRESCRIPTION DRUG LABEL

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [KELTMAN PHARMACEUTICALS INC.]3
HYDROCODONE BITARTRATEACTIVE INGREDIENTNO70W886KKHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [KELTMAN PHARMACEUTICALS INC.]3
ACETAMINOPHENACTIVE MOIETY362O9ITL9DHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [KELTMAN PHARMACEUTICALS INC.]3
HYDROCODONEACTIVE MOIETY6YKS4Y3WQ7HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [KELTMAN PHARMACEUTICALS INC.]3
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [KELTMAN PHARMACEUTICALS INC.]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [KELTMAN PHARMACEUTICALS INC.]3
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [KELTMAN PHARMACEUTICALS INC.]3
CROSPOVIDONEINACTIVE INGREDIENT68401960MKHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [KELTMAN PHARMACEUTICALS INC.]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [KELTMAN PHARMACEUTICALS INC.]3
POVIDONEINACTIVE INGREDIENTFZ989GH94EHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [KELTMAN PHARMACEUTICALS INC.]3
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [KELTMAN PHARMACEUTICALS INC.]3
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [KELTMAN PHARMACEUTICALS INC.]3

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 149 of 155 · 3,088 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Arthritis PainACETAMINOPHENBETTER LIVING BRANDS, LLCee84323a-b615-3ec6-e053-2995a90a5a262023-06-15WarningsExact identifier
unii: 362O9ITL9D
8 Hour Pain ReliefACETAMINOPHENSTRATEGIC SOURCING SERVICES LLCc003a34a-bfe5-4298-8a4e-8c75576f56742023-06-09WarningsExact identifier
unii: 362O9ITL9D
Butalbital, Acetaminophen, CaffeineBUTALBITAL, ACETAMINOPHEN, AND CAFFEINEBryant Ranch Prepack90e166ac-8789-4e7a-b5bb-37c475e3a5b02023-06-08Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
DG health dual pain relieverACETAMINOPHEN, IBUPROFENDolgencorp Inc464d436a-79b0-45b4-8b5f-51dc2de2d8e42023-05-19WarningsExact identifier
unii: 362O9ITL9D
AcetaminophenACETAMINOPHENB. Braun Medical Inc.6d763554-913d-4bed-9efd-b9c9b936a2f42023-05-18Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
eight hour pain reliefACETAMINOPHENUnited Natural Foods, Inc. dba UNFIb5fe8873-13c9-402e-b06c-6e679af7267e2023-05-17WarningsExact identifier
unii: 362O9ITL9D
ACETAMINOPHEN ASPIRIN AND CAFFEINEACETAMINOPHEN, ASPIRIN AND CAFFEINEAurohealth LLCe47e2169-4b31-4c23-bb9d-c26aa106ea372023-05-11WarningsExact identifier
unii: 362O9ITL9D
pain reliever fever reducer childrensACETAMINOPHENWalgreen Companyf2085b26-5778-4656-8de3-9edd83f914dd2023-05-03WarningsExact identifier
unii: 362O9ITL9D
Migraine ReliefACETAMINOPHEN, ASPIRIN AND CAFFEINEAAA PHARMACEUTICAL, INC.f9c9a0b4-dbfe-7da9-e053-6294a90a7e092023-05-03WarningsExact identifier
unii: 362O9ITL9D
AcetaminophenACETAMINOPHENWG Critical Care, LLC60f0d5b2-cab4-4a7c-8b53-1526a0908a542023-05-03Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
8 hr Arthritis Pain ReliefACETAMINOPHENDOLGENCORP, INC.ea2eae7c-e9bd-534c-e053-2a95a90a26c82023-04-20WarningsExact identifier
unii: 362O9ITL9D
8 hr Pain ReliefACETAMINOPHENDOLGENCORP, INC.ea2ebb7b-ceab-567a-e053-2995a90aa4022023-04-20WarningsExact identifier
unii: 362O9ITL9D
HEBACETAMINOPHENHEB96b1808f-defa-28cb-e053-2995a90a563b2023-04-12WarningsExact identifier
unii: 362O9ITL9D
butalbital, acetaminophen and caffeineBUTALBITAL, ACETAMINOPHEN AND CAFFEINEBryant Ranch Prepack3875c01b-7cd6-4bed-8d4e-c580c55408602023-04-11Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
Arthritis Pain ReliefACETAMINOPHENWINCO FOODS, LLCf45f43da-b994-2bc8-e053-2995a90a93e02023-04-11WarningsExact identifier
unii: 362O9ITL9D
DG Health migraine reliefACETAMINOPHEN, ASPIRIN, CAFFEINEDolgencorp, LLCd0e82cac-dfbb-49cb-99c8-560b02fb1a8c2023-04-05WarningsExact identifier
unii: 362O9ITL9D
Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENProficient Rx LP82b24978-8b15-43a9-b5b0-3313ed2a73c22023-04-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: NO70W886KK
unii: 362O9ITL9D
equate pain relieverACETAMINOPHEN, IBUPROFENWALMART INC.8e0aaae0-a97d-4b9d-b326-44ef45f3fa0c2023-03-17WarningsExact identifier
unii: 362O9ITL9D
Butalbital, Acetaminophen and CaffeineBUTALBITAL, ACETAMINOPHEN AND CAFFEINEGolden State Medical Supply, Inc.ee131bce-863b-b5a1-e053-2a95a90afc792023-03-16Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
basic care migraine reliefACETAMINOPHEN, ASPIRIN, CAFFEINEAmazon.com Services LLCedcc7b4b-1317-4060-b947-8c16effc57422023-02-27WarningsExact identifier
unii: 362O9ITL9D

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.