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 153 of 154 · 3,078 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Acetaminophen 500mg ESACETAMINOPHEN 500MGAllegiant Health91acc132-01b6-467b-9af5-70f4dc93e0872019-01-08WarningsExact identifier
unii: 362O9ITL9D
Acetaminophen 325mg RSACETAMINOPHEN 325MGAllegiant Health61c6d281-e59b-4277-bbce-f71c12c2a56d2019-01-07WarningsExact identifier
unii: 362O9ITL9D
Cold Multi-SymptomACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLAllegiant Health9a4c0c43-a71a-4e22-a3d5-9eb9622689a22019-01-02WarningsExact identifier
unii: 362O9ITL9D
Pressure Pain Mucus PEACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEChain Drug Marketing Association1e54ecb3-c3c3-477a-8725-23f24e77a44b2018-12-31WarningsExact identifier
unii: 362O9ITL9D
Pain Relief PM Extra StrengthACETAMINOPHEN 500 MG AND DIPHENHYDRAMINE HCL 25 MGAllegiant Health423a8445-964c-4cdb-889a-f391ca5253e72018-12-31WarningsExact identifier
unii: 362O9ITL9D
Cold Multi-Symptom Night-timeACETAMINOPHEN,CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR AND PHENYLEPHRINE HCIAllegiant Health3f020cf2-6011-4216-9b39-0b3dc5f0749c2018-12-26WarningsExact identifier
unii: 362O9ITL9D
Sinus Headache PEMaximum Strength Non-Drowsy Maximum Strength Non-DrowsyACETAMINOPHEN AND PHENYLEPHRINE HCLAllegiant Healthb04b96e0-d99b-48d1-b8b8-e2fdd8dd3f5f2018-12-21WarningsExact identifier
unii: 362O9ITL9D
ACETAMINOPHENACETAMINOPHENTIME CAP LABORATORIES, INC2569383a-4a05-4ddb-852e-b37e487ffcde2018-12-17WarningsExact identifier
unii: 362O9ITL9D
Comfort-TimeACETAMINOPHEN, CAFFEINE, AND PYRILAMINE MALEATETime Cap Labs, Ince94a26a2-36e5-4e1e-aea1-24e035c980432018-12-14WarningsExact identifier
unii: 362O9ITL9D
Severe Cold Head CongestionACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEMarc Glassman, Inc.3a774544-1994-4a93-9da9-06e55b1a83c82018-12-13WarningsExact identifier
unii: 362O9ITL9D
Clear Choice Regular Strength Pain RelieverACETAMINOPHENAthlete's Needs, Inc.d0d9fda5-5eba-4d51-b505-e93a2ae0bdd72018-12-11WarningsExact identifier
unii: 362O9ITL9D
AcetaminophenACETAMINOPHENWalgreen Companya1cec332-5802-4684-8b7f-6cb98da40e8b2018-08-15WarningsExact identifier
unii: 362O9ITL9D
Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENSun Pharmaceutical Industries, Inc.6e153073-ca78-481e-9e9c-0365ee3f3d592018-07-31Boxed warning, Warnings, Adverse reactionsExact identifier
unii: NO70W886KK
unii: 362O9ITL9D
Pain Relief PMACETAMINOPHEN PMVelocity Pharmac1c1de91-6a54-4d91-93a9-b6be6d7c7dfb2018-05-14WarningsExact identifier
unii: 362O9ITL9D
AcetaminophenACETAMINOPHENVelocity Pharma LLCbba2ddc5-19e0-4f11-8ff7-7dd7c2d53b502018-05-14WarningsExact identifier
unii: 362O9ITL9D
Oxycodone and AcetaminophenOXYCODONE AND ACETAMINOPHENCamber Pharmaceuticals, Inc.2a49ee34-6f1d-4ed3-8daa-343723d2a2be2018-02-20Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
Childrens Multi-symptom Cold and Fever LiquidACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLWal-Mart Stores, Inc.7bf30c75-e867-4a2f-a481-702d7aa96c232018-01-08WarningsExact identifier
unii: 362O9ITL9D
AcetaminophenACETAMINOPHENAdvance Pharmaceutical Inc.3793a17e-13bf-4d27-b8fa-6753b760f8202017-12-22WarningsExact identifier
unii: 362O9ITL9D
ACETAMINOPHEN PMACETAMINOPHEN PMAdvance Pharmaceutical Inc.b172226e-8f2a-4d9c-b7c7-dd737b90463a2017-12-22WarningsExact identifier
unii: 362O9ITL9D
APAPACETAMINOPHENAdvance Pharmaceutical Inc.aba26f0a-94e4-4919-a3b0-033e3a9598ef2017-12-22WarningsExact identifier
unii: 362O9ITL9D

Reported adverse events (FAERS/openFDA)#

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