Hydrocodone Bitartrate and Acetaminophen

Product NDC
63629-7822
11-digit product format
636297822
Labeler code
63629
Product ID
63629-7822_e3c3e1a8-8250-4836-b75b-a8bb57aa71cb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydrocodone Bitartrate and Acetaminophen
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA201013
Marketing category
ANDA
Marketing start
2012-04-11
Marketing end
0000-00-00
Substance
HYDROCODONE BITARTRATE; ACETAMINOPHEN
Active strength
8 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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-7822-1EA - Each63629-78224a474137-475d-4b41-80fa-1326a4f543b212019-01-24

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-7822-16362978220121 TABLET in 1 BOTTLE (63629-7822-1) 21 tablet2012-04-110000-00-00NoNoCurrent
63629-7822-26362978220236 TABLET in 1 BOTTLE (63629-7822-2) 36 tablet2021-12-150000-00-00NoNoCurrent