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Promethazine Hydrochloride - 50383-801-16 - (Promethazine Hydrochloride)

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Drug Information of Promethazine Hydrochloride

Product NDC: 50383-801
Proprietary Name: Promethazine Hydrochloride
Non Proprietary Name: Promethazine Hydrochloride
Active Ingredient(s): 6.25    mg/5mL & nbsp;   Promethazine Hydrochloride
Administration Route(s): ORAL
Dosage Form(s): SOLUTION
Coding System: National Drug Codes(NDC)

Labeler Information of Promethazine Hydrochloride

Product NDC: 50383-801
Labeler Name: Hi-Tech Pharmacal Co., Inc.
Product Type: HUMAN PRESCRIPTION DRUG
FDA Application Number: ANDA040026
Marketing Category: ANDA
Start Marketing Date: 19980925

Package Information of Promethazine Hydrochloride

Package NDC: 50383-801-16
Package Description: 473 mL in 1 BOTTLE, GLASS (50383-801-16)

NDC Information of Promethazine Hydrochloride

NDC Code 50383-801-16
Proprietary Name Promethazine Hydrochloride
Package Description 473 mL in 1 BOTTLE, GLASS (50383-801-16)
Product NDC 50383-801
Product Type Name HUMAN PRESCRIPTION DRUG
Non Proprietary Name Promethazine Hydrochloride
Dosage Form Name SOLUTION
Route Name ORAL
Start Marketing Date 19980925
Marketing Category Name ANDA
Labeler Name Hi-Tech Pharmacal Co., Inc.
Substance Name PROMETHAZINE HYDROCHLORIDE
Strength Number 6.25
Strength Unit mg/5mL
Pharmaceutical Classes Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient]

Complete Information of Promethazine Hydrochloride


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