Promethazine VC

Product NDC

68788-6763

11-digit product format

687886763

Labeler code

68788

Product ID

68788-6763_7c7443de-ad12-45f5-b439-c668ab5ae9fb

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

Promethazinehydrochloride and phenylephrine hydrochloride

Dosage form

SYRUP

Route

ORAL

Labeler

Preferred Pharmaceuticals, Inc.

Application

ANDA040654

Marketing category

ANDA

Marketing start

2012-07-25

Marketing end

0000-00-00

Substance

PROMETHAZINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE

Active strength

6 mg/5mL; mg/5mL

Pharmacologic classes

Phenothiazine [EPC],Phenothiazines [CS],alpha-1 Adrenergic Agonist [EPC],Adrenergic alpha1-Agonists [MoA]

NDC exclude flag

E

Listing certified through

2017-12-31

Current FDA listing

Historical FDA.report record