Hydrocodone Bitartrate and Acetaminophen

Product NDC
63629-8887
11-digit product format
636298887
Labeler code
63629
Product ID
63629-8887_d64ec11c-e7c3-4ab4-a293-f99c389a0d06
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydrocodone Bitartrate and Acetaminophen
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA210211
Marketing category
ANDA
Marketing start
2018-07-13
Marketing end
0000-00-00
Substance
HYDROCODONE BITARTRATE; ACETAMINOPHEN
Active strength
5 mg/1; mg/1
Pharmacologic classes
Opioid Agonist [EPC],Opioid Agonists [MoA]
DEA schedule
CII
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-8887-16362988870130 TABLET in 1 BOTTLE (63629-8887-1) 30 tablet2021-10-210000-00-00NoNoCurrent
63629-8887-26362988870215 TABLET in 1 BOTTLE (63629-8887-2) 15 tablet2021-10-210000-00-00NoNoCurrent
63629-8887-36362988870328 TABLET in 1 BOTTLE (63629-8887-3) 28 tablet2021-10-210000-00-00NoNoCurrent
63629-8887-46362988870456 TABLET in 1 BOTTLE (63629-8887-4) 56 tablet2021-10-210000-00-00NoNoCurrent
63629-8887-56362988870560 TABLET in 1 BOTTLE (63629-8887-5) 60 tablet2021-10-210000-00-00NoNoCurrent
63629-8887-66362988870690 TABLET in 1 BOTTLE (63629-8887-6) 90 tablet2021-10-210000-00-00NoNoCurrent
63629-8887-763629888707120 TABLET in 1 BOTTLE (63629-8887-7) 120 tablet2021-10-210000-00-00NoNoCurrent