Promethazine Hydrochloride

Product NDC

40085-218

11-digit product format

400850218

Labeler code

40085

Product ID

40085-218_fc539046-58bc-4530-a688-296333d5c9b1

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

Promethazine Hydrochloride

Dosage form

SUPPOSITORY

Route

RECTAL

Labeler

Renaissance Pharma, Inc.

Application

ANDA040428

Marketing category

ANDA

Marketing start

2014-08-01

Marketing end

2020-02-29

Substance

PROMETHAZINE HYDROCHLORIDE

Active strength

13 mg/1

Pharmacologic classes

Phenothiazine [EPC],Phenothiazines [CS]

NDC exclude flag

No

Listing certified through

0000-00-00

Current FDA listing

Historical FDA.report record