Acetaminophen and Codeine Phosphate

Product NDC
50090-0215
11-digit product format
500900215
Labeler code
50090
Product ID
50090-0215_40e0fef0-f52f-4fd2-84b3-a812cffe483e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ACETAMINOPHEN and CODEINE PHOSPHATE
Dosage form
SOLUTION
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA087508
Marketing category
ANDA
Marketing start
1981-08-21
Marketing end
0000-00-00
Substance
ACETAMINOPHEN; CODEINE PHOSPHATE
Active strength
120 mg/5mL; mg/5mL
Pharmacologic classes
Full Opioid Agonists [MoA],Opioid Agonist [EPC]
DEA schedule
CV
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-0215-02023-02-07C16284748780-1f386c64a-01b5-0266-e053-dadaa90a7c1a31cce165-fdfb-434c-83c2-fcc7709c03f4
50090-0215-02023-01-30C16284748780-1f386c64a-01b5-0266-e053-dadaa90a7c1a31cce165-fdfb-434c-83c2-fcc7709c03f4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-0215-0ML - Milliliter50090-021506dbd93e-7d4c-437e-a0b7-e4792e81465312018-08-13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-0215-050090021500118 mL in 1 BOTTLE (50090-0215-0) 118 ml2014-11-280000-00-00NoNoCurrent