HYDROCODONE BITARTRATE AND ACETAMINOPHEN

Product NDC
70518-2923
11-digit product format
705182923
Labeler code
70518
Product ID
70518-2923_d798b67b-6b42-c43a-e053-2a95a90a3350
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
HYDROCODONE BITARTRATE AND ACETAMINOPHEN
Dosage form
TABLET
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA040400
Marketing category
ANDA
Marketing start
2020-10-26
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70518-2923-02022-02-09C16284748780-1d6a99b39-fe32-a426-e053-dadaa90af4c283d039fe-4c45-4447-83de-a03d57af5ba0
70518-2923-02022-01-28C16284748780-1d6a99b39-fe32-a426-e053-dadaa90af4c283d039fe-4c45-4447-83de-a03d57af5ba0

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-2923-0705182923004 TABLET in 1 BOTTLE, PLASTIC (70518-2923-0) 4 tablet2020-10-260000-00-00NoNoCurrent