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Hydromorphone Hydrochloride - 0054-0386-63 - (hydromorphone hydrochloride)

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Drug Information of Hydromorphone Hydrochloride

Product NDC: 0054-0386
Proprietary Name: Hydromorphone Hydrochloride
Non Proprietary Name: hydromorphone hydrochloride
Active Ingredient(s): 1    mg/mL & nbsp;   hydromorphone hydrochloride
Administration Route(s): ORAL
Dosage Form(s): SOLUTION
Coding System: National Drug Codes(NDC)

Labeler Information of Hydromorphone Hydrochloride

Product NDC: 0054-0386
Labeler Name: Roxane Laboratories, Inc
Product Type: HUMAN PRESCRIPTION DRUG
FDA Application Number: ANDA074653
Marketing Category: ANDA
Start Marketing Date: 20120301

Package Information of Hydromorphone Hydrochloride

Package NDC: 0054-0386-63
Package Description: 473 mL in 1 BOTTLE (0054-0386-63)

NDC Information of Hydromorphone Hydrochloride

NDC Code 0054-0386-63
Proprietary Name Hydromorphone Hydrochloride
Package Description 473 mL in 1 BOTTLE (0054-0386-63)
Product NDC 0054-0386
Product Type Name HUMAN PRESCRIPTION DRUG
Non Proprietary Name hydromorphone hydrochloride
Dosage Form Name SOLUTION
Route Name ORAL
Start Marketing Date 20120301
Marketing Category Name ANDA
Labeler Name Roxane Laboratories, Inc
Substance Name HYDROMORPHONE HYDROCHLORIDE
Strength Number 1
Strength Unit mg/mL
Pharmaceutical Classes Full Opioid Agonists [MoA],Opioid Agonist [EPC]

Complete Information of Hydromorphone Hydrochloride


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