Hydromet - 0472-1030-16 - (Hydrocodone Bitartate and Homatropine Methylbromide)

Alphabetical Index


Drug Information of Hydromet

Product NDC: 0472-1030
Proprietary Name: Hydromet
Non Proprietary Name: Hydrocodone Bitartate and Homatropine Methylbromide
Active Ingredient(s): 1.5; 5    mg/5mL; mg/5mL & nbsp;   Hydrocodone Bitartate and Homatropine Methylbromide
Administration Route(s): ORAL
Dosage Form(s): SYRUP
Coding System: National Drug Codes(NDC)

Labeler Information of Hydromet

Product NDC: 0472-1030
Labeler Name: Actavis Mid Atlantic LLC
Product Type: HUMAN PRESCRIPTION DRUG
FDA Application Number: ANDA088017
Marketing Category: ANDA
Start Marketing Date: 20081201

Package Information of Hydromet

Package NDC: 0472-1030-16
Package Description: 473 mL in 1 BOTTLE (0472-1030-16)

NDC Information of Hydromet

NDC Code 0472-1030-16
Proprietary Name Hydromet
Package Description 473 mL in 1 BOTTLE (0472-1030-16)
Product NDC 0472-1030
Product Type Name HUMAN PRESCRIPTION DRUG
Non Proprietary Name Hydrocodone Bitartate and Homatropine Methylbromide
Dosage Form Name SYRUP
Route Name ORAL
Start Marketing Date 20081201
Marketing Category Name ANDA
Labeler Name Actavis Mid Atlantic LLC
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 Hydromet


General Information