| Product NDC: | 50102-100 |
| Proprietary Name: | Norethindrone |
| Non Proprietary Name: | Norethindrone |
| Active Ingredient(s): | .35 mg/1 & nbsp; Norethindrone |
| Administration Route(s): | ORAL |
| Dosage Form(s): | TABLET |
| Coding System: | National Drug Codes(NDC) |
| Product NDC: | 50102-100 |
| Labeler Name: | Afaxys Inc. |
| Product Type: | HUMAN PRESCRIPTION DRUG |
| FDA Application Number: | ANDA200980 |
| Marketing Category: | ANDA |
| Start Marketing Date: | 20130624 |
| Package NDC: | 50102-100-48 |
| Package Description: | 48 CARTON in 1 CASE (50102-100-48) > 1 BLISTER PACK in 1 CARTON > 28 TABLET in 1 BLISTER PACK |
| NDC Code | 50102-100-48 |
| Proprietary Name | Norethindrone |
| Package Description | 48 CARTON in 1 CASE (50102-100-48) > 1 BLISTER PACK in 1 CARTON > 28 TABLET in 1 BLISTER PACK |
| Product NDC | 50102-100 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Non Proprietary Name | Norethindrone |
| Dosage Form Name | TABLET |
| Route Name | ORAL |
| Start Marketing Date | 20130624 |
| Marketing Category Name | ANDA |
| Labeler Name | Afaxys Inc. |
| Substance Name | NORETHINDRONE |
| Strength Number | .35 |
| Strength Unit | mg/1 |
| Pharmaceutical Classes | Progesterone Congeners [Chemical/Ingredient],Progestin [EPC] |