PROMETHAZINE DM

Product NDC

70518-0418

11-digit product format

705180418

Labeler code

70518

Product ID

70518-0418_84f6a71f-5f81-cdb0-e053-2a91aa0a6209

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

Dextromethorphan Hydrobromide and Promethazine Hydrochloride

Dosage form

SOLUTION

Route

ORAL

Labeler

REMEDYREPACK INC.

Application

ANDA040649

Marketing category

ANDA

Marketing start

2017-06-05

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