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Hydrocodone Bitartrate and Homatropine Methylbromide - 50383-043-16 - (Hydrocodone Bitartrate and Homatropine Methylbromide)

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Drug Information of Hydrocodone Bitartrate and Homatropine Methylbromide

Product NDC: 50383-043
Proprietary Name: Hydrocodone Bitartrate and Homatropine Methylbromide
Non Proprietary Name: Hydrocodone Bitartrate and Homatropine Methylbromide
Active Ingredient(s): 1.5; 5    mg/5mL; mg/5mL & nbsp;   Hydrocodone Bitartrate and Homatropine Methylbromide
Administration Route(s): ORAL
Dosage Form(s): SYRUP
Coding System: National Drug Codes(NDC)

Labeler Information of Hydrocodone Bitartrate and Homatropine Methylbromide

Product NDC: 50383-043
Labeler Name: Hi-Tech Pharmacal Co., Inc.
Product Type: HUMAN PRESCRIPTION DRUG
FDA Application Number: ANDA040613
Marketing Category: ANDA
Start Marketing Date: 20080208

Package Information of Hydrocodone Bitartrate and Homatropine Methylbromide

Package NDC: 50383-043-16
Package Description: 473 mL in 1 BOTTLE (50383-043-16)

NDC Information of Hydrocodone Bitartrate and Homatropine Methylbromide

NDC Code 50383-043-16
Proprietary Name Hydrocodone Bitartrate and Homatropine Methylbromide
Package Description 473 mL in 1 BOTTLE (50383-043-16)
Product NDC 50383-043
Product Type Name HUMAN PRESCRIPTION DRUG
Non Proprietary Name Hydrocodone Bitartrate and Homatropine Methylbromide
Dosage Form Name SYRUP
Route Name ORAL
Start Marketing Date 20080208
Marketing Category Name ANDA
Labeler Name Hi-Tech Pharmacal Co., Inc.
Substance Name HOMATROPINE METHYLBROMIDE; HYDROCODONE BITARTRATE
Strength Number 1.5; 5
Strength Unit mg/5mL; mg/5mL
Pharmaceutical Classes Opioid Agonist [EPC],Opioid Agonists [MoA]

Complete Information of Hydrocodone Bitartrate and Homatropine Methylbromide


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