DailyMed - LEVONORGESTREL AND ETHINYL ESTRADIOL- levonorgestrel and ethinyl estradiol kit

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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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

#	Item Code	Package Description	Marketing Start Date
Packaging
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

Part #	Package Quantity	Total Product Quantity
Quantity of Parts
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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
LEVONORGESTREL (UNII: 5W7SIA7YZW) (LEVONORGESTREL - UNII:5W7SIA7YZW)	LEVONORGESTREL	0.1 mg
ETHINYL ESTRADIOL (UNII: 423D2T571U) (ETHINYL ESTRADIOL - UNII:423D2T571U)	ETHINYL ESTRADIOL	0.02 mg

Ingredient Name	Strength
Inactive Ingredients
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA200493	01/01/2017

Part 2 of 2

ETHINYL ESTRADIOL
ethinyl estradiol tablet

Product Information
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ETHINYL ESTRADIOL (UNII: 423D2T571U) (ETHINYL ESTRADIOL - UNII:423D2T571U)	ETHINYL ESTRADIOL	0.01 mg

Ingredient Name	Strength
Inactive Ingredients
.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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA200493	01/01/2017

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA200493	01/01/2017

Labeler - Jai Pharma Limited (650882132)

Registrant - Jai Pharma Limited (650882132)

Name	Address	ID/FEI	Business Operations
Establishment
Jai Pharma Limited		677604150	analysis(57994-008) , label(57994-008) , manufacture(57994-008) , pack(57994-008)

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Published Date (What is this?)	Version	Files
Jan 3, 2017	1 (current)	download

	RxCUI	RxNorm NAME	RxTTY
1	242297	levonorgestrel 0.1 MG / ethinyl estradiol 0.02 MG Oral Tablet	PSN
2	242297	Ethinyl Estradiol 0.02 MG / Levonorgestrel 0.1 MG Oral Tablet	SCD
3	248310	ethinyl estradiol 0.01 MG Oral Tablet	PSN
4	248310	Ethinyl Estradiol 0.01 MG Oral Tablet	SCD
5	248310	ethinyl estradiol 10 MCG Oral Tablet	SY
6	310230	ethinyl estradiol 0.03 MG / levonorgestrel 0.05 MG Oral Tablet	PSN
7	310230	Ethinyl Estradiol 0.03 MG / Levonorgestrel 0.05 MG Oral Tablet	SCD
8	348804	ethinyl estradiol 0.03 MG / levonorgestrel 0.125 MG Oral Tablet	PSN
9	348804	Ethinyl Estradiol 0.03 MG / Levonorgestrel 0.125 MG Oral Tablet	SCD
10	348804	ethinyl estradiol 30 MCG / levonorgestrel 125 MCG Oral Tablet	SY
11	348805	ethinyl estradiol 0.04 MG / levonorgestrel 0.075 MG Oral Tablet	PSN
12	348805	Ethinyl Estradiol 0.04 MG / Levonorgestrel 0.075 MG Oral Tablet	SCD
13	348805	ethinyl estradiol 40 MCG / levonorgestrel 75 MCG Oral Tablet	SY
14	748797	inert 1 MG Oral Tablet	PSN
15	748797	Inert Ingredients 1 MG Oral Tablet	SCD
16	748832	Eth estra-Levonorgest 0.03-0.05 MG (6) Oral Tablet / Eth estra-Levonorgest 0.03-0.125 MG (10) Oral Tablet / Eth estra-Levonorgest 0.04-0.075 MG (5) Oral Tablet / Inert 1 MG (7) Oral Tablet 28 Day Pack	PSN
17	748832	{6 (Ethinyl Estradiol 0.03 MG / Levonorgestrel 0.05 MG Oral Tablet) / 10 (Ethinyl Estradiol 0.03 MG / Levonorgestrel 0.125 MG Oral Tablet) / 5 (Ethinyl Estradiol 0.04 MG / Levonorgestrel 0.075 MG Oral Tablet) / 7 (Inert Ingredients 1 MG Oral Tablet) } Pack	GPCK

RxCUI

RxNorm NAME

RxTTY

242297

levonorgestrel 0.1 MG / ethinyl estradiol 0.02 MG Oral Tablet

PSN

242297

Ethinyl Estradiol 0.02 MG / Levonorgestrel 0.1 MG Oral Tablet

SCD

248310

ethinyl estradiol 0.01 MG Oral Tablet

PSN

248310

Ethinyl Estradiol 0.01 MG Oral Tablet

SCD

248310

ethinyl estradiol 10 MCG Oral Tablet

310230

ethinyl estradiol 0.03 MG / levonorgestrel 0.05 MG Oral Tablet

PSN

310230

Ethinyl Estradiol 0.03 MG / Levonorgestrel 0.05 MG Oral Tablet

SCD

348804

ethinyl estradiol 0.03 MG / levonorgestrel 0.125 MG Oral Tablet

PSN

348804

Ethinyl Estradiol 0.03 MG / Levonorgestrel 0.125 MG Oral Tablet

SCD

348804

ethinyl estradiol 30 MCG / levonorgestrel 125 MCG Oral Tablet

348805

ethinyl estradiol 0.04 MG / levonorgestrel 0.075 MG Oral Tablet

PSN

348805

Ethinyl Estradiol 0.04 MG / Levonorgestrel 0.075 MG Oral Tablet

SCD

348805

ethinyl estradiol 40 MCG / levonorgestrel 75 MCG Oral Tablet

748797

inert 1 MG Oral Tablet

PSN

748797

Inert Ingredients 1 MG Oral Tablet

SCD

748832

Eth estra-Levonorgest 0.03-0.05 MG (6) Oral Tablet / Eth estra-Levonorgest 0.03-0.125 MG (10) Oral Tablet / Eth estra-Levonorgest 0.04-0.075 MG (5) Oral Tablet / Inert 1 MG (7) Oral Tablet 28 Day Pack

PSN

748832

{6 (Ethinyl Estradiol 0.03 MG / Levonorgestrel 0.05 MG Oral Tablet) / 10 (Ethinyl Estradiol 0.03 MG / Levonorgestrel 0.125 MG Oral Tablet) / 5 (Ethinyl Estradiol 0.04 MG / Levonorgestrel 0.075 MG Oral Tablet) / 7 (Inert Ingredients 1 MG Oral Tablet) } Pack

GPCK

Label: LEVONORGESTREL AND ETHINYL ESTRADIOL- levonorgestrel and ethinyl estradiol kit

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Label: LEVONORGESTREL AND ETHINYL ESTRADIOL- levonorgestrel and ethinyl estradiol kit

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Drug Label Info

Safety

Related Resources

More Info For This Drug

Drug Label Information

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Safety

Related Resources

More Info on this Drug

LEVONORGESTREL AND ETHINYL ESTRADIOL- levonorgestrel and ethinyl estradiol kit

Number of versions: 1

LEVONORGESTREL AND ETHINYL ESTRADIOL- levonorgestrel and ethinyl estradiol kit

LEVONORGESTREL AND ETHINYL ESTRADIOL- levonorgestrel and ethinyl estradiol kit

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LEVONORGESTREL AND ETHINYL ESTRADIOL- levonorgestrel and ethinyl estradiol kit

If this SPL contains inactivated NDCs listed by the FDA initiated compliance action, they will be specified as such.