EXALGO - 16590-942-60 - (HYDROMORPHONE HYDROCHLORIDE)

Alphabetical Index


Drug Information of EXALGO

Product NDC: 16590-942
Proprietary Name: EXALGO
Non Proprietary Name: HYDROMORPHONE HYDROCHLORIDE
Active Ingredient(s): 8    mg/1 & nbsp;   HYDROMORPHONE HYDROCHLORIDE
Administration Route(s): ORAL
Dosage Form(s): TABLET, EXTENDED RELEASE
Coding System: National Drug Codes(NDC)

Labeler Information of EXALGO

Product NDC: 16590-942
Labeler Name: STAT Rx USA LLC
Product Type: HUMAN PRESCRIPTION DRUG
FDA Application Number: NDA021217
Marketing Category: NDA
Start Marketing Date: 20110314

Package Information of EXALGO

Package NDC: 16590-942-60
Package Description: 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (16590-942-60)

NDC Information of EXALGO

NDC Code 16590-942-60
Proprietary Name EXALGO
Package Description 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (16590-942-60)
Product NDC 16590-942
Product Type Name HUMAN PRESCRIPTION DRUG
Non Proprietary Name HYDROMORPHONE HYDROCHLORIDE
Dosage Form Name TABLET, EXTENDED RELEASE
Route Name ORAL
Start Marketing Date 20110314
Marketing Category Name NDA
Labeler Name STAT Rx USA LLC
Substance Name HYDROMORPHONE HYDROCHLORIDE
Strength Number 8
Strength Unit mg/1
Pharmaceutical Classes Full Opioid Agonists [MoA],Opioid Agonist [EPC]

Complete Information of EXALGO


General Information