Promethazine Hydrochloride

Product NDC
71205-805
11-digit product format
712050805
Labeler code
71205
Product ID
71205-805_dcb1694a-8451-403c-b848-edb89ba17020
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Promethazine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA040596
Marketing category
ANDA
Marketing start
2005-12-14
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
71205-805-157120508051515 TABLET in 1 BOTTLE (71205-805-15) 15 tablet2023-05-23NoNoHistorical
71205-805-307120508053030 TABLET in 1 BOTTLE (71205-805-30) 30 tablet2023-05-23NoNoHistorical
71205-805-607120508056060 TABLET in 1 BOTTLE (71205-805-60) 60 tablet2023-05-23NoNoHistorical
71205-805-907120508059090 TABLET in 1 BOTTLE (71205-805-90) 90 tablet2023-05-23NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Promethazine Hydrochloride Tablets USPProficient Rx LP2023-05-01HUMAN PRESCRIPTION DRUG LABEL1