ZYDONE - 16590-350-62 - (HYDROCODONE BITARTRATE AND ACETAMINOPHEN)

Alphabetical Index


Drug Information of ZYDONE

Product NDC: 16590-350
Proprietary Name: ZYDONE
Non Proprietary Name: HYDROCODONE BITARTRATE AND ACETAMINOPHEN
Active Ingredient(s): 400; 7.5    mg/1; mg/1 & nbsp;   HYDROCODONE BITARTRATE AND ACETAMINOPHEN
Administration Route(s): ORAL
Dosage Form(s): TABLET
Coding System: National Drug Codes(NDC)

Labeler Information of ZYDONE

Product NDC: 16590-350
Labeler Name: STAT RX USA LLC
Product Type: HUMAN PRESCRIPTION DRUG
FDA Application Number: ANDA040288
Marketing Category: ANDA
Start Marketing Date: 19981201

Package Information of ZYDONE

Package NDC: 16590-350-62
Package Description: 84 TABLET in 1 BOTTLE (16590-350-62)

NDC Information of ZYDONE

NDC Code 16590-350-62
Proprietary Name ZYDONE
Package Description 84 TABLET in 1 BOTTLE (16590-350-62)
Product NDC 16590-350
Product Type Name HUMAN PRESCRIPTION DRUG
Non Proprietary Name HYDROCODONE BITARTRATE AND ACETAMINOPHEN
Dosage Form Name TABLET
Route Name ORAL
Start Marketing Date 19981201
Marketing Category Name ANDA
Labeler Name STAT RX USA LLC
Substance Name ACETAMINOPHEN; HYDROCODONE BITARTRATE
Strength Number 400; 7.5
Strength Unit mg/1; mg/1
Pharmaceutical Classes Opioid Agonist [EPC],Opioid Agonists [MoA]

Complete Information of ZYDONE


General Information