PROMETHAZINE HYDROCHLORIDE

Product NDC
50090-4750
11-digit product format
500904750
Labeler code
50090
Product ID
50090-4750_f90a7e25-88b3-4d4f-9930-964418e6cf8c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
promethazine hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA040712
Marketing category
ANDA
Marketing start
2006-07-31
Substance
PROMETHAZINE HYDROCHLORIDE
Active strength
25 mg/1
Pharmacologic classes
Phenothiazine [EPC], Phenothiazines [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
R61ZEH7I1IPROMETHAZINE HYDROCHLORIDE58-33-3PROMETHAZINE HYDROCHLORIDE

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
50090-4750-05009047500012 TABLET in 1 BOTTLE (50090-4750-0) 12 tablet2019-11-22NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
PROMETHAZINE HYDROCHLORIDE TABLETS, USPA-S Medication Solutions2023-10-24HUMAN PRESCRIPTION DRUG LABEL5