Acetaminophen and Codeine Phosphate

Product NDC
50090-1935
11-digit product format
500901935
Labeler code
50090
Product ID
50090-1935_cdb01913-d6e9-4a6c-94f7-ded4330a0b40
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Acetaminophen and Codeine Phosphate
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA202800
Marketing category
ANDA
Marketing start
2013-04-15
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
50090-1935-02023-02-07C16284748780-1f386c649-a786-0266-e053-dadaa90a7c1a8c66128c-58c8-4f44-bb69-df60d64dedee
50090-1935-02023-01-30C16284748780-1f386c649-a786-0266-e053-dadaa90a7c1a8c66128c-58c8-4f44-bb69-df60d64dedee

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-1935-0EA - Each50090-1935d8bff89a-a1fe-4674-b415-44502293e7a712018-11-06

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-1935-05009019350015 TABLET in 1 BOTTLE (50090-1935-0) 15 tablet2015-07-160000-00-00NoNoCurrent