Zamicet

Product NDC
0121-2313
11-digit product format
001212313
Labeler code
0121
Product ID
0121-2313_2872e73b-2895-4319-8c65-2ec29c17d0ad
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
HYDROCODONE BITARTRATE and ACETAMINOPHEN
Dosage form
SOLUTION
Route
ORAL
Labeler
Pharmaceutical Associates, Inc.
Application
ANDA040834
Marketing category
ANDA
Marketing start
2008-08-18
Marketing end
0000-00-00
Substance
HYDROCODONE BITARTRATE; ACETAMINOPHEN
Active strength
10 mg/15mL; mg/15mL
Pharmacologic classes
Opioid Agonist [EPC],Opioid Agonists [MoA]
DEA schedule
CII
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0121-2313-402024-11-15C16284748780-1d6a99b39-e965-a426-e053-dadaa90af4c2c84877aa-5b61-4603-9494-fcf95d22a1f1
0121-2313-402022-01-28C16284748780-1d6a99b39-e965-a426-e053-dadaa90af4c2c84877aa-5b61-4603-9494-fcf95d22a1f1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0121-2313-40001212313404 TRAY in 1 CASE (0121-2313-40) > 10 CUP, UNIT-DOSE in 1 TRAY > 15 mL in 1 CUP, UNIT-DOSE (0121-2313-15) 4 tray2008-08-180000-00-00NoNoCurrent