FDA.reportPublic FDA data

NDC 63304-497-11 - 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
63304-497
Requested NDC
63304-497-11
Package NDCs from labels
63304-497-03, 63304-497-05, 63304-497-01, 63304-497-10, 63304-497-11, 63304-497-69
Manufacturer
Sun Pharmaceutical Industries, Inc. | Ohm Laboratories Inc
Effective date
2018-07-31
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
ACETAMINOPHEN - Sun Pharmaceutical Industries, Inc. | Ohm Laboratories IncSun Pharmaceutical Industries, Inc. | Ohm Laboratories Inc2018-07-31HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63304-497-01Hydrocodone Bitartrate and Acetaminophen100 in 1 BOTTLETABLET10012
63304-497-03Hydrocodone Bitartrate and Acetaminophen10 in 1 BOTTLETABLET1012
63304-497-05Hydrocodone Bitartrate and Acetaminophen500 in 1 BOTTLETABLET50012
63304-497-10Hydrocodone Bitartrate and Acetaminophen1000 in 1 BOTTLETABLET100012
63304-497-11Hydrocodone Bitartrate and Acetaminophen1 in 1 BLISTER PACKTABLET112
63304-497-69Hydrocodone Bitartrate and Acetaminophen10 in 1 CARTONTABLET1012

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63304-497HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.]12Current NDC, Legacy NDC, 6 package rows20180731_6e153073-ca78-481e-9e9c-0365ee3f3d59.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63304-497-01EA - Each63304-4971c02525c-8912-438d-9273-287e9225eeda12013-07-02
63304-497-05EA - Each63304-497da75a38e-36bd-45f0-8532-ac86260e22e712013-07-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [RANBAXY PHARMACEUTICALS INC.]7
HYDROCODONE BITARTRATEACTIVE INGREDIENTNO70W886KKHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [RANBAXY PHARMACEUTICALS INC.]7
ACETAMINOPHENACTIVE MOIETY362O9ITL9DHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [RANBAXY PHARMACEUTICALS INC.]7
HYDROCODONEACTIVE MOIETY6YKS4Y3WQ7HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [RANBAXY PHARMACEUTICALS INC.]7
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [RANBAXY PHARMACEUTICALS INC.]7
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [RANBAXY PHARMACEUTICALS INC.]7
CROSPOVIDONEINACTIVE INGREDIENT68401960MKHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [RANBAXY PHARMACEUTICALS INC.]7
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [RANBAXY PHARMACEUTICALS INC.]7
POVIDONESINACTIVE INGREDIENTFZ989GH94EHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [RANBAXY PHARMACEUTICALS INC.]7
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [RANBAXY PHARMACEUTICALS INC.]7
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [RANBAXY PHARMACEUTICALS INC.]7
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [RANBAXY PHARMACEUTICALS INC.]7

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 2 of 182 · 3,638 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
severe cold and cough daytimeACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDERARITAN PHARMACEUTICALS INC3ce8508e-7d9d-4413-858a-8f952e760c012026-09-08WarningsExact identifier
unii: 362O9ITL9D
Multi Symptom Severe ColdACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLRARITAN PHARMACEUTICALS INCd9606c9a-31b1-4121-9870-809a05f5b68a2026-09-08WarningsExact identifier
unii: 362O9ITL9D
DESENFRIOL-ITO PLUSACETAMINOPHENOPMX LLC5ac41edd-e845-734d-e063-6294a90a990a2026-09-05WarningsExact identifier
unii: 362O9ITL9D
DRX CHOICE Regular StrengthACETAMINOPHENRaritan Pharmaceuticals Inc.8bacb24a-24d0-4175-b3e0-05efb5f5d3732026-09-05WarningsExact identifier
unii: 362O9ITL9D
Severe Congestion and PainACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCLMeijer Distribution, Inc.49235f4f-e661-4a83-88ef-b9a9568487772026-09-04WarningsExact identifier
unii: 362O9ITL9D
NIGHTTIME COLD AND FLUACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEAmazon.com Services LLC774d2bde-9f57-4ced-800a-cada39c685ed2026-09-04WarningsExact identifier
unii: 362O9ITL9D
Psoriasis ControlCENTELLA ASIATICA, SODIUM CHLORIDE, AND SILICON DIOXIDEForces of Nature2db33771-0bb9-49f8-84fa-dddc28e4ba262026-09-04WarningsExact identifier
unii: ETJ7Z6XBU4
Butalbital, Acetaminophen, CaffeineBUTALBITAL, ACETAMINOPHEN, AND CAFFEINEREMEDYREPACK INC.dc2bb7fc-1722-4865-a02c-be5e5c2115052026-09-03Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
Feverall Jr. StrengthACETAMINOPHENSun Pharmaceutical Industries, Inc.3561bbc3-53b0-4857-8b71-39e165ed95ce2026-09-03WarningsExact identifier
unii: 362O9ITL9D
infants pain and feverACETAMINOPHENCVS Pharmacy53b06c48-598e-41ad-ac7a-5508c195535c2026-09-03WarningsExact identifier
unii: 362O9ITL9D
AMAZON BASIC CARE ACETAMINOPHENACETAMINOPHENAmazon.com Services LLC113d92bf-f6c9-cc3d-e063-6294a90af0332026-09-02WarningsExact identifier
unii: 362O9ITL9D
Childrens Multi Symptom Fever and ColdACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLTHE KROGER CO.3daf7620-eb57-43d5-ba88-938b7221e3462026-09-02WarningsExact identifier
unii: 362O9ITL9D
Extra Strength Pain RelieverACETAMINOPHENShield Pharmaceuticals Corp.78052120-40d8-4a3f-b72f-cc78ca76213b2026-09-02WarningsExact identifier
unii: 362O9ITL9D
Nighttime Cold and Flu Multi Symptom ReliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEShield Pharmaceuticals Corpdecafa3a-3734-4161-bab0-1219458818462026-09-02WarningsExact identifier
unii: 362O9ITL9D
Nighttime Severe Cold and CoughACETAMINOPHEN, DIPHENHYDRAMINE, PHENYLEPHRINEKROGER COMPANY7def6781-0881-46bf-ad7a-7a3f23a8d9f72026-09-02WarningsExact identifier
unii: 362O9ITL9D
Maximum Strength Cold Flu and Sore ThroatACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLKROGER COMPANYe1d27123-358f-4b0c-8e3b-33474750a0e62026-09-02WarningsExact identifier
unii: 362O9ITL9D
Kroger Nighttime Cold and Flu ReliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEKroger Companyc5ce0901-a5d7-46c4-8492-5a80c76e85172026-09-02WarningsExact identifier
unii: 362O9ITL9D
Maximum Strength Nighttime Cold and FluACETAMINOPHEN , DIPHENHYDRAMINE HCL,PHENYLEPHRINE HCLTHE KROGER CO058b2021-8a61-40b0-8a2e-a784d2b847fb2026-09-02WarningsExact identifier
unii: 362O9ITL9D
Daytime Cold and Flu ReliefACETAMINOHPEN, DEXTROMETHORPHAN HBR, GUAIFENESIN PHENYLEPHRINE HCLThe Kroger Co.494e69ef-dc9f-4e14-b856-5eaf0f541a032026-09-02WarningsExact identifier
unii: 362O9ITL9D
Kroger Children Pain plus Fever chewablesACETAMINOPHENKROGER COMPANY83b5733c-70a1-4383-9729-2eb896d0149a2026-09-01WarningsExact identifier
unii: 362O9ITL9D

Reported adverse events (FAERS/openFDA)#

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