Hydrocodone Bitartrate and Acetaminophen

Product NDC
63629-2295
11-digit product format
636292295
Labeler code
63629
Product ID
63629-2295_e72c2226-b86e-473f-a820-8955f6587615
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydrocodone Bitartrate and Acetaminophen
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA202214
Marketing category
ANDA
Marketing start
2014-10-06
Substance
ACETAMINOPHEN; HYDROCODONE BITARTRATE
Active strength
325; 7.5 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
63629-2295-163629229501100 TABLET in 1 BOTTLE, PLASTIC (63629-2295-1) 100 tablet2014-10-06NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Hydrocodone Bitartrate and AcetaminophenBryant Ranch Prepack2024-08-12HUMAN PRESCRIPTION DRUG LABEL106