hydrocodone bitartrate and acetaminophen

Product NDC
63629-1179
11-digit product format
636291179
Labeler code
63629
Product ID
63629-1179_9df309b1-d246-4eb4-b91b-e326c86c1751
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
hydrocodone bitartrate and acetaminophen
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA207509
Marketing category
ANDA
Marketing start
2020-09-01
Substance
ACETAMINOPHEN; HYDROCODONE BITARTRATE
Active strength
300; 5 mg/1; mg/1
Pharmacologic classes
Opioid Agonist [EPC], Opioid Agonists [MoA]
DEA schedule
CII
NDC exclude flag
No
Listing certified through
2027-12-31
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
63629-1179-163629117901500 TABLET in 1 BOTTLE (63629-1179-1) 500 tablet2020-09-01NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Hydrocodone Bitartrate and Acetaminophen Tablets, USPBryant Ranch Prepack2026-03-20HUMAN PRESCRIPTION DRUG LABEL4