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REZIRA
REZIRA - 63717-875-16 - (hydrocodone bitartrate, pseudoephedrine hydrochloride)
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: | 63717-875-16 |
| Package Description: | 480 mL in 1 BOTTLE (63717-875-16) |
NDC Information of REZIRA
| NDC Code | 63717-875-16 |
| Proprietary Name | REZIRA |
| Package Description | 480 mL in 1 BOTTLE (63717-875-16) |
| 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] |
