Label: LEVONORGESTREL AND ETHINYL ESTRADIOL- levonorgestrel and ethinyl estradiol kit
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Contains inactivated NDC Code(s)
NDC Code(s): 57994-008-90 - Packager: Jai Pharma Limited
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated September 27, 2016
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INGREDIENTS AND APPEARANCE
LEVONORGESTREL AND ETHINYL ESTRADIOL
levonorgestrel and ethinyl estradiol kitProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:57994-008 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:57994-008-90 2 in 1 CARTON 01/01/2017 1 1 in 1 POUCH 1 1 in 1 BLISTER PACK; Type 0: Not a Combination Product Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 84 Part 2 7 Part 1 of 2 LEVONORGESTREL AND ETHINYL ESTRADIOL
levonorgestrel and ethinyl estradiol tabletProduct Information Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LEVONORGESTREL (UNII: 5W7SIA7YZW) (LEVONORGESTREL - UNII:5W7SIA7YZW) LEVONORGESTREL 0.1 mg ETHINYL ESTRADIOL (UNII: 423D2T571U) (ETHINYL ESTRADIOL - UNII:423D2T571U) ETHINYL ESTRADIOL 0.02 mg Inactive Ingredients Ingredient Name Strength LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) MAGNESIUM STEARATE (UNII: 70097M6I30) POLACRILIN POTASSIUM (UNII: 0BZ5A00FQU) Product Characteristics Color WHITE Score no score Shape ROUND Size 6mm Flavor Imprint Code 214 Contains Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA200493 01/01/2017 Part 2 of 2 ETHINYL ESTRADIOL
ethinyl estradiol tabletProduct Information Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ETHINYL ESTRADIOL (UNII: 423D2T571U) (ETHINYL ESTRADIOL - UNII:423D2T571U) ETHINYL ESTRADIOL 0.01 mg Inactive Ingredients Ingredient Name Strength .ALPHA.-TOCOPHEROL, DL- (UNII: 7QWA1RIO01) ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) MAGNESIUM STEARATE (UNII: 70097M6I30) POLACRILIN POTASSIUM (UNII: 0BZ5A00FQU) POVIDONE K25 (UNII: K0KQV10C35) Product Characteristics Color ORANGE (Light Peach) Score no score Shape ROUND Size 6mm Flavor Imprint Code 215 Contains Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA200493 01/01/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA200493 01/01/2017 Labeler - Jai Pharma Limited (650882132) Registrant - Jai Pharma Limited (650882132) Establishment Name Address ID/FEI Business Operations Jai Pharma Limited 677604150 analysis(57994-008) , label(57994-008) , manufacture(57994-008) , pack(57994-008)
