Hydrocodone Bitartrate and Acetaminophen

Product NDC
63629-7821
11-digit product format
636297821
Labeler code
63629
Product ID
63629-7821_7fffdbd4-a816-4fbe-a885-1985a351db13
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydrocodone Bitartrate and Acetaminophen
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA040736
Marketing category
ANDA
Marketing start
2010-01-18
Marketing end
0000-00-00
Substance
ACETAMINOPHEN; HYDROCODONE BITARTRATE
Active strength
325 mg/1; mg/1
Pharmacologic classes
Opioid Agonist [EPC], Opioid Agonists [MoA]
DEA schedule
CII
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-7821-16362978210121 TABLET in 1 BOTTLE (63629-7821-1) 21 tablet2018-12-040000-00-00NoNoCurrent
63629-7821-26362978210212 TABLET in 1 BOTTLE (63629-7821-2) 12 tablet2018-12-280000-00-00NoNoCurrent