PROMETHAZINE DM

Product NDC

68788-9097

11-digit product format

687889097

Labeler code

68788

Product ID

68788-9097_7e4eef52-0f3b-446b-9e6e-17d175a23dfe

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

Dextromethorphan Hydrobromide and Promethazine Hydrochloride

Dosage form

SOLUTION

Route

ORAL

Labeler

Preferred Pharmaceuticals, Inc.

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

2020-12-31

Current FDA listing

Historical FDA.report record