| Product NDC: | 51079-027 |
| Proprietary Name: | Quinidine Gluconate |
| Non Proprietary Name: | Quinidine Gluconate |
| Active Ingredient(s): | 324 mg/1 & nbsp; Quinidine Gluconate |
| Administration Route(s): | ORAL |
| Dosage Form(s): | TABLET, EXTENDED RELEASE |
| Coding System: | National Drug Codes(NDC) |
| Product NDC: | 51079-027 |
| Labeler Name: | UDL Laboratories, Inc. |
| Product Type: | HUMAN PRESCRIPTION DRUG |
| FDA Application Number: | ANDA089338 |
| Marketing Category: | ANDA |
| Start Marketing Date: | 20110823 |
| Package NDC: | 51079-027-20 |
| Package Description: | 100 BLISTER PACK in 1 BOX, UNIT-DOSE (51079-027-20) > 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (51079-027-01) |
| NDC Code | 51079-027-20 |
| Proprietary Name | Quinidine Gluconate |
| Package Description | 100 BLISTER PACK in 1 BOX, UNIT-DOSE (51079-027-20) > 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (51079-027-01) |
| Product NDC | 51079-027 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Non Proprietary Name | Quinidine Gluconate |
| Dosage Form Name | TABLET, EXTENDED RELEASE |
| Route Name | ORAL |
| Start Marketing Date | 20110823 |
| Marketing Category Name | ANDA |
| Labeler Name | UDL Laboratories, Inc. |
| Substance Name | QUINIDINE GLUCONATE |
| Strength Number | 324 |
| Strength Unit | mg/1 |
| Pharmaceutical Classes | Antiarrhythmic [EPC],Cytochrome P450 2D6 Inhibitor [EPC],Cytochrome P450 2D6 Inhibitors [MoA] |