NDC 62037-566-01 - 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
62037-566
Requested NDC
62037-566-01
Package NDCs from labels
62037-566-01, 62037-566-05
Manufacturer
Andrx Pharmaceuticals, Inc.
Effective date
2008-07-29
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLETS, USP 5 mg/500 mgAndrx Pharmaceuticals, Inc.2008-07-29HUMAN PRESCRIPTION DRUG LABELING

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62037-566-01HYDROCODONE BITARTRATE AND ACETAMINOPHEN100 in 1 BOTTLETABLET1002
62037-566-05HYDROCODONE BITARTRATE AND ACETAMINOPHEN500 in 1 BOTTLETABLET5002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62037-566HYDROCODONE BITARTRATE AND ACETAMINOPHEN (HYDROCODONE BITARTRATE AND ACETAMINOPHEN) TABLET [ANDRX PHARMACEUTICALS, INC.]22 package rows20080807_686def04-0a09-400a-916e-af8d2661ec22.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AcetaminophenACTIVE INGREDIENT362O9ITL9DHYDROCODONE BITARTRATE AND ACETAMINOPHEN (HYDROCODONE BITARTRATE AND ACETAMINOPHEN) TABLET [ANDRX PHARMACEUTICALS, INC.]2
Hydrocodone BitartrateACTIVE INGREDIENTNO70W886KKHYDROCODONE BITARTRATE AND ACETAMINOPHEN (HYDROCODONE BITARTRATE AND ACETAMINOPHEN) TABLET [ANDRX PHARMACEUTICALS, INC.]2
AcetaminophenACTIVE MOIETY362O9ITL9DHYDROCODONE BITARTRATE AND ACETAMINOPHEN (HYDROCODONE BITARTRATE AND ACETAMINOPHEN) TABLET [ANDRX PHARMACEUTICALS, INC.]2
HydrocodoneACTIVE MOIETY6YKS4Y3WQ7HYDROCODONE BITARTRATE AND ACETAMINOPHEN (HYDROCODONE BITARTRATE AND ACETAMINOPHEN) TABLET [ANDRX PHARMACEUTICALS, INC.]2
colloidal silicon dioxideINACTIVE INGREDIENTETJ7Z6XBU4HYDROCODONE BITARTRATE AND ACETAMINOPHEN (HYDROCODONE BITARTRATE AND ACETAMINOPHEN) TABLET [ANDRX PHARMACEUTICALS, INC.]2
corn starch (pregelatinized)INACTIVE INGREDIENTHYDROCODONE BITARTRATE AND ACETAMINOPHEN (HYDROCODONE BITARTRATE AND ACETAMINOPHEN) TABLET [ANDRX PHARMACEUTICALS, INC.]2
croscarmellose sodiumINACTIVE INGREDIENTHYDROCODONE BITARTRATE AND ACETAMINOPHEN (HYDROCODONE BITARTRATE AND ACETAMINOPHEN) TABLET [ANDRX PHARMACEUTICALS, INC.]2
crospovidoneINACTIVE INGREDIENTHYDROCODONE BITARTRATE AND ACETAMINOPHEN (HYDROCODONE BITARTRATE AND ACETAMINOPHEN) TABLET [ANDRX PHARMACEUTICALS, INC.]2
magnesium stearateINACTIVE INGREDIENT70097M6I30HYDROCODONE BITARTRATE AND ACETAMINOPHEN (HYDROCODONE BITARTRATE AND ACETAMINOPHEN) TABLET [ANDRX PHARMACEUTICALS, INC.]2
microcrystalline celluloseINACTIVE INGREDIENTOP1R32D61UHYDROCODONE BITARTRATE AND ACETAMINOPHEN (HYDROCODONE BITARTRATE AND ACETAMINOPHEN) TABLET [ANDRX PHARMACEUTICALS, INC.]2
povidoneINACTIVE INGREDIENTFZ989GH94EHYDROCODONE BITARTRATE AND ACETAMINOPHEN (HYDROCODONE BITARTRATE AND ACETAMINOPHEN) TABLET [ANDRX PHARMACEUTICALS, INC.]2
stearic acidINACTIVE INGREDIENT4ELV7Z65APHYDROCODONE BITARTRATE AND ACETAMINOPHEN (HYDROCODONE BITARTRATE AND ACETAMINOPHEN) TABLET [ANDRX PHARMACEUTICALS, INC.]2

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 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
D84CC0D3-09B2-B81F-4145-3AD7CFFAE75B686def04-0a09-400a-916e-af8d2661ec222008-07-29Warnings, Adverse reactionsExact identifier
spl id: D84CC0D3-09B2-B81F-4145-3AD7CFFAE75B
spl set id: 686def04-0a09-400a-916e-af8d2661ec22

Reported adverse events (FAERS/openFDA)#

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