REZIRA - 63717-875-99 - (hydrocodone bitartrate, pseudoephedrine hydrochloride)

Alphabetical Index


Drug Information of REZIRA

Product NDC: 63717-875
Proprietary Name: REZIRA
Non Proprietary Name: hydrocodone bitartrate, pseudoephedrine hydrochloride
Active Ingredient(s): 5; 60    mg/5mL; mg/5mL & nbsp;   hydrocodone bitartrate, pseudoephedrine hydrochloride
Administration Route(s): ORAL
Dosage Form(s): SOLUTION
Coding System: National Drug Codes(NDC)

Labeler Information of REZIRA

Product NDC: 63717-875
Labeler Name: Hawthorn Pharmaceuticals, Inc.
Product Type: HUMAN PRESCRIPTION DRUG
FDA Application Number: NDA022442
Marketing Category: NDA
Start Marketing Date: 20110608

Package Information of REZIRA

Package NDC: 63717-875-99
Package Description: 12 BOTTLE in 1 CARTON (63717-875-99) > 5 mL in 1 BOTTLE

NDC Information of REZIRA

NDC Code 63717-875-99
Proprietary Name REZIRA
Package Description 12 BOTTLE in 1 CARTON (63717-875-99) > 5 mL in 1 BOTTLE
Product NDC 63717-875
Product Type Name HUMAN PRESCRIPTION DRUG
Non Proprietary Name hydrocodone bitartrate, pseudoephedrine hydrochloride
Dosage Form Name SOLUTION
Route Name ORAL
Start Marketing Date 20110608
Marketing Category Name NDA
Labeler Name Hawthorn Pharmaceuticals, Inc.
Substance Name HYDROCODONE BITARTRATE; PSEUDOEPHEDRINE HYDROCHLORIDE
Strength Number 5; 60
Strength Unit mg/5mL; mg/5mL
Pharmaceutical Classes Opioid Agonist [EPC],Opioid Agonists [MoA],Adrenergic alpha-Agonists [MoA],alpha-Adrenergic Agonist [EPC]

Complete Information of REZIRA


General Information