| Product NDC: | 51285-963 |
| Proprietary Name: | Plan B One-Step |
| Non Proprietary Name: | levonorgestrel |
| Active Ingredient(s): | 1.5 mg/1 & nbsp; levonorgestrel |
| Administration Route(s): | ORAL |
| Dosage Form(s): | TABLET |
| Coding System: | National Drug Codes(NDC) |
| Product NDC: | 51285-963 |
| Labeler Name: | Duramed Pharmaceuticals, Inc. |
| Product Type: | HUMAN PRESCRIPTION DRUG |
| FDA Application Number: | NDA021998 |
| Marketing Category: | NDA |
| Start Marketing Date: | 20090710 |
| Package NDC: | 51285-963-19 |
| Package Description: | 1 BLISTER PACK in 1 CARTON (51285-963-19) > 1 TABLET in 1 BLISTER PACK |
| NDC Code | 51285-963-19 |
| Proprietary Name | Plan B One-Step |
| Package Description | 1 BLISTER PACK in 1 CARTON (51285-963-19) > 1 TABLET in 1 BLISTER PACK |
| Product NDC | 51285-963 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Non Proprietary Name | levonorgestrel |
| Dosage Form Name | TABLET |
| Route Name | ORAL |
| Start Marketing Date | 20090710 |
| Marketing Category Name | NDA |
| Labeler Name | Duramed Pharmaceuticals, Inc. |
| Substance Name | LEVONORGESTREL |
| Strength Number | 1.5 |
| Strength Unit | mg/1 |
| Pharmaceutical Classes | Inhibit Ovum Fertilization [PE],Progesterone Congeners [Chemical/Ingredient],Progesterone Congeners [Chemical/Ingredient],Progestin [EPC],Progestin-containing Intrauterine Device [EPC] |