FDA.reportPublic FDA data

Hydrocodone Bitartrate and Acetaminophen

Product NDC
63629-5434
11-digit product format
636295434
Labeler code
63629
Product ID
63629-5434_878efd95-3026-4583-adc2-1fbcb5566441
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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-5434-0EA - Each63629-543442065acd-7d2f-4562-97a9-6d1dcfc573ac12015-10-02
63629-5434-1EA - Each63629-54344b6b13d5-2df8-4803-bdb3-0e8bb68efe1312015-10-02
63629-5434-2EA - Each63629-543421c93e02-7c40-43dd-9901-71ea259b103612015-10-02
63629-5434-3EA - Each63629-54340e34bf1c-e465-4711-97e5-aff3a49913f712015-10-02
63629-5434-4EA - Each63629-5434efd3f30d-de35-4132-9920-21c6194fc12a12015-10-02
63629-5434-5EA - Each63629-54345f087858-b1b4-4e23-bbd7-9de6105a95d612015-10-02
63629-5434-6EA - Each63629-5434469897f1-df79-4e97-b1e1-18e359f47eb812015-10-02
63629-5434-7EA - Each63629-54348815e4a1-b6aa-4a65-94c4-e7c7fd5c894912015-10-02
63629-5434-8EA - Each63629-54344940b730-51e9-451f-a3f7-87e213f9710812015-10-02
63629-5434-9EA - Each63629-5434d5b7da10-76e1-4b46-9ea7-452709d417e312015-10-02

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-5434-063629543400120 TABLET in 1 BOTTLE (63629-5434-0) 120 tablet2014-10-080000-00-00NoNoCurrent
63629-5434-16362954340120 TABLET in 1 BOTTLE (63629-5434-1) 20 tablet2014-10-170000-00-00NoNoCurrent
63629-5434-26362954340230 TABLET in 1 BOTTLE (63629-5434-2) 30 tablet2014-10-060000-00-00NoNoCurrent
63629-5434-36362954340340 TABLET in 1 BOTTLE (63629-5434-3) 40 tablet2014-10-160000-00-00NoNoCurrent
63629-5434-46362954340445 TABLET in 1 BOTTLE (63629-5434-4) 45 tablet2022-02-020000-00-00NoNoCurrent
63629-5434-56362954340556 TABLET in 1 BOTTLE (63629-5434-5) 56 tablet2014-10-200000-00-00NoNoCurrent
63629-5434-66362954340660 TABLET in 1 BOTTLE (63629-5434-6) 60 tablet2014-10-060000-00-00NoNoCurrent
63629-5434-76362954340784 TABLET in 1 BOTTLE (63629-5434-7) 84 tablet2014-10-200000-00-00NoNoCurrent
63629-5434-86362954340890 TABLET in 1 BOTTLE (63629-5434-8) 90 tablet2014-10-060000-00-00NoNoCurrent
63629-5434-963629543409100 TABLET in 1 BOTTLE (63629-5434-9) 100 tablet2015-10-090000-00-00NoNoCurrent