LEVONORGESTREL AND ETHINYL ESTRADIOL- levonorgestrel and ethinyl estradiol kit

LEVONORGESTREL AND ETHINYL ESTRADIOL by

Drug Labeling and Warnings

LEVONORGESTREL AND ETHINYL ESTRADIOL by is a Prescription medication manufactured, distributed, or labeled by Jai Pharma Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

LEVONORGESTREL AND ETHINYL ESTRADIOL  
levonorgestrel and ethinyl estradiol kit

Product 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 tablet

Product 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 tablet

Product 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)