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Lybrel
Lybrel - 0008-1117-35 - (levonorgestrel and ethinyl estradiol)
Drug Information of Lybrel
| Product NDC: | 0008-1117 |
| Proprietary Name: | Lybrel |
| Non Proprietary Name: | levonorgestrel and ethinyl estradiol |
| Active Ingredient(s): | 20; 90 ug/1; ug/1 & nbsp; levonorgestrel and ethinyl estradiol |
| Administration Route(s): | ORAL |
| Dosage Form(s): | TABLET, FILM COATED |
| Coding System: | National Drug Codes(NDC) |
Labeler Information of Lybrel
| Product NDC: | 0008-1117 |
| Labeler Name: | Wyeth Pharmaceuticals Company, a subsidiary of Pfizer Inc. |
| Product Type: | HUMAN PRESCRIPTION DRUG |
| FDA Application Number: | NDA021864 |
| Marketing Category: | NDA |
| Start Marketing Date: | 20070601 |
Package Information of Lybrel
| Package NDC: | 0008-1117-35 |
| Package Description: | 10 CARTON in 1 CARTON (0008-1117-35) > 1 CASE in 1 CARTON (0008-1117-34) > 28 TABLET, FILM COATED in 1 CASE |
NDC Information of Lybrel
| NDC Code | 0008-1117-35 |
| Proprietary Name | Lybrel |
| Package Description | 10 CARTON in 1 CARTON (0008-1117-35) > 1 CASE in 1 CARTON (0008-1117-34) > 28 TABLET, FILM COATED in 1 CASE |
| Product NDC | 0008-1117 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Non Proprietary Name | levonorgestrel and ethinyl estradiol |
| Dosage Form Name | TABLET, FILM COATED |
| Route Name | ORAL |
| Start Marketing Date | 20070601 |
| Marketing Category Name | NDA |
| Labeler Name | Wyeth Pharmaceuticals Company, a subsidiary of Pfizer Inc. |
| Substance Name | ETHINYL ESTRADIOL; LEVONORGESTREL |
| Strength Number | 20; 90 |
| Strength Unit | ug/1; ug/1 |
| Pharmaceutical Classes | Inhibit Ovum Fertilization [PE],Progesterone Congeners [Chemical/Ingredient],Progesterone Congeners [Chemical/Ingredient],Progestin [EPC],Progestin-containing Intrauterine Device [EPC],Estrogen [EPC],Estrogen Receptor Agonists [MoA] |
