PROMETHAZINE DM

Product NDC

50436-1867

11-digit product format

504361867

Labeler code

50436

Product ID

50436-1867_14f7c995-e018-4cc6-8b48-d160aa2c9047

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

Dextromethorphan Hydrobromide and Promethazine Hydrochloride

Dosage form

SOLUTION

Route

ORAL

Labeler

Unit Dose Services

Application

ANDA040649

Marketing category

ANDA

Marketing start

2006-02-14

Marketing end

0000-00-00

Substance

DEXTROMETHORPHAN HYDROBROMIDE; PROMETHAZINE HYDROCHLORIDE

Active strength

15 mg/5mL; mg/5mL

Pharmacologic classes

Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC],Sigma-1 Agonist [EPC],Uncompetitive NMDA Receptor Antagonists [MoA],Sigma-1 Receptor Agonists [MoA],Phenothiazine [EPC],Phenothiazines [CS]

NDC exclude flag

No

Listing certified through

2019-12-31

Current FDA listing

Historical FDA.report record