EXALGO - 54868-6387-0 - (Hydromorphone Hydrochloride)

Alphabetical Index


Drug Information of EXALGO

Product NDC: 54868-6387
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: 54868-6387
Labeler Name: Physicians Total Care, Inc.
Product Type: HUMAN PRESCRIPTION DRUG
FDA Application Number: NDA021217
Marketing Category: NDA
Start Marketing Date: 20121231

Package Information of EXALGO

Package NDC: 54868-6387-0
Package Description: 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (54868-6387-0)

NDC Information of EXALGO

NDC Code 54868-6387-0
Proprietary Name EXALGO
Package Description 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (54868-6387-0)
Product NDC 54868-6387
Product Type Name HUMAN PRESCRIPTION DRUG
Non Proprietary Name Hydromorphone Hydrochloride
Dosage Form Name TABLET, EXTENDED RELEASE
Route Name ORAL
Start Marketing Date 20121231
Marketing Category Name NDA
Labeler Name Physicians Total Care, Inc.
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