Lybrel - 0008-1117-35 - (levonorgestrel and ethinyl estradiol)

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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]

Complete Information of Lybrel


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