Hydrocodone Bitartrate and Acetaminophen

Product NDC
60760-873
11-digit product format
607600873
Labeler code
60760
Product ID
60760-873_42528890-10b7-0ca6-e063-6394a90a346c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydrocodone Bitartrate and Acetaminophen
Dosage form
TABLET
Route
ORAL
Labeler
ST. MARY'S MEDICAL PARK PHARMACY
Application
ANDA202214
Marketing category
ANDA
Marketing start
2014-10-06
Substance
ACETAMINOPHEN; HYDROCODONE BITARTRATE
Active strength
325; 5 mg/1; mg/1
Pharmacologic classes
Opioid Agonist [EPC], Opioid Agonists [MoA]
DEA schedule
CII
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
362O9ITL9DACETAMINOPHEN103-90-2ACETAMINOPHEN
NO70W886KKHYDROCODONE BITARTRATE34195-34-1HYDROCODONE BITARTRATE

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
60760-873-606076008736060 TABLET in 1 BOTTLE, PLASTIC (60760-873-60) 60 tablet2025-10-29NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Hydrocodone Bitartrate and AcetaminophenST. MARY'S MEDICAL PARK PHARMACY2025-10-29HUMAN PRESCRIPTION DRUG LABEL1