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NDC 00713-0526-10 PROMETHEGAN 25 mg/1 Details

PROMETHEGAN 25 mg/1

PROMETHEGAN is a RECTAL SUPPOSITORY in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Cosette Pharmaceuticals, Inc.. The primary component is PROMETHAZINE HYDROCHLORIDE.

MedlinePlus Drug Summary

Promethazine is used to relieve the symptoms of allergic reactions such as allergic rhinitis (runny nose and watery eyes caused by allergy to pollen, mold or dust), allergic conjunctivitis (red, watery eyes caused by allergies), allergic skin reactions, and allergic reactions to blood or plasma products. Promethazine is used with other medications to treat anaphylaxis (sudden, severe allergic reactions) and the symptoms of the common cold such as sneezing, cough, and runny nose. Promethazine is also used to relax and sedate patients before and after surgery, during labor, and at other times. Promethazine is also used to prevent and control nausea and vomiting that may occur after surgery, and with other medications to help relieve pain after surgery. Promethazine is also used to prevent and treat motion sickness. Promethazine helps control symptoms, but will not treat the cause of the symptoms or speed recovery. Promethazine is in a class of medications called phenothiazines. It works by blocking the action of a certain natural substance in the body.

Related Packages: 00713-0526-10
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Promethazine

Product Information

NDC	00713-0526
Product ID	0713-0526_0b622b7b-a45f-eab0-e063-6394a90a0c0a
Associated GPIs	41400020105210
GCN Sequence Number	003873
GCN Sequence Number Description	promethazine HCl SUPP.RECT 25 MG RECTAL
HIC3	H6J
HIC3 Description	ANTIEMETIC/ANTIVERTIGO AGENTS
GCN	15001
HICL Sequence Number	012014
HICL Sequence Number Description	PROMETHAZINE HCL
Brand/Generic	Generic
Proprietary Name	PROMETHEGAN
Proprietary Name Suffix	n/a
Non-Proprietary Name	Promethazine Hydrochloride
Product Type	HUMAN PRESCRIPTION DRUG
Dosage Form	SUPPOSITORY
Route	RECTAL
Active Ingredient Strength	25
Active Ingredient Units	mg/1
Substance Name	PROMETHAZINE HYDROCHLORIDE
Labeler Name	Cosette Pharmaceuticals, Inc.
Pharmaceutical Class	Phenothiazine [EPC], Phenothiazines [CS]
DEA Schedule	n/a
Marketing Category	ANDA
Application Number	ANDA040428
Listing Certified Through	2024-12-31

Package

NDC 00713-0526-10 (00713052610)

Pricing Information	N/A
NDC Package Code	0713-0526-10
Billing NDC	00713052610
Package	1000 SUPPOSITORY in 1 BOX (0713-0526-10)
Marketing Start Date	2002-02-28
NDC Exclude Flag	N