ACETAMINOPHEN AND CODEINE PHOSPHATE

Product NDC
50090-5198
11-digit product format
500905198
Labeler code
50090
Product ID
50090-5198_b28bbc9f-a299-43e6-b9bb-eb5f9b1a017a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
acetaminophen and codeine phosphate
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA211610
Marketing category
ANDA
Marketing start
2019-08-02
Marketing end
0000-00-00
Substance
ACETAMINOPHEN; CODEINE PHOSPHATE
Active strength
300 mg/1; mg/1
Pharmacologic classes
Full Opioid Agonists [MoA],Opioid Agonist [EPC]
DEA schedule
CIII
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-5198-02023-02-07C16284748780-1f386c64a-1e64-0266-e053-dadaa90a7c1aa9dc0d7b-d27d-48c9-ae37-fc406f599e73
50090-5198-02023-01-30C16284748780-1f386c64a-1e64-0266-e053-dadaa90a7c1aa9dc0d7b-d27d-48c9-ae37-fc406f599e73

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-5198-05009051980015 TABLET in 1 BOTTLE (50090-5198-0) 15 tablet2020-10-020000-00-00NoNoCurrent