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Betapace AF
Betapace AF - 50419-119-06 - (sotalol hydrochloride)
Drug Information of Betapace AF
| Product NDC: | 50419-119 |
| Proprietary Name: | Betapace AF |
| Non Proprietary Name: | sotalol hydrochloride |
| Active Ingredient(s): | 120 mg/1 & nbsp; sotalol hydrochloride |
| Administration Route(s): | ORAL |
| Dosage Form(s): | TABLET |
| Coding System: | National Drug Codes(NDC) |
Labeler Information of Betapace AF
| Product NDC: | 50419-119 |
| Labeler Name: | Bayer HealthCare Pharmaceuticals Inc. |
| Product Type: | HUMAN PRESCRIPTION DRUG |
| FDA Application Number: | NDA021151 |
| Marketing Category: | NDA |
| Start Marketing Date: | 20000222 |
Package Information of Betapace AF
| Package NDC: | 50419-119-06 |
| Package Description: | 1 BOTTLE, PLASTIC in 1 PACKAGE (50419-119-06) > 60 TABLET in 1 BOTTLE, PLASTIC |
NDC Information of Betapace AF
| NDC Code | 50419-119-06 |
| Proprietary Name | Betapace AF |
| Package Description | 1 BOTTLE, PLASTIC in 1 PACKAGE (50419-119-06) > 60 TABLET in 1 BOTTLE, PLASTIC |
| Product NDC | 50419-119 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Non Proprietary Name | sotalol hydrochloride |
| Dosage Form Name | TABLET |
| Route Name | ORAL |
| Start Marketing Date | 20000222 |
| Marketing Category Name | NDA |
| Labeler Name | Bayer HealthCare Pharmaceuticals Inc. |
| Substance Name | SOTALOL HYDROCHLORIDE |
| Strength Number | 120 |
| Strength Unit | mg/1 |
| Pharmaceutical Classes | Antiarrhythmic [EPC] |
