Hydrocodone Bitartrate and Acetaminophen

Product NDC
63629-7823
11-digit product format
636297823
Labeler code
63629
Product ID
63629-7823_cdd1fab9-55dd-415b-8c06-3bee193736a6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydrocodone Bitartrate and Acetaminophen
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA040746
Marketing category
ANDA
Marketing start
2010-02-18
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
63629-7823-16362978230121 TABLET in 1 BOTTLE (63629-7823-1) 21 tablet2010-02-180000-00-00NoNoCurrent
63629-7823-26362978230215 TABLET in 1 BOTTLE (63629-7823-2) 15 tablet2018-12-040000-00-00NoNoCurrent
63629-7823-36362978230310 TABLET in 1 BOTTLE (63629-7823-3) 10 tablet2018-12-040000-00-00NoNoCurrent