Ayuna (Page 7 of 7)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL — 0.15 mg/0.03 mg (28 Tablets Pouch)

NDC 65862-848-28
Ayuna®
(levonorgestrel and
ethinyl
estradiol tablets USP)
0.15 mg/0.03 mg

21 orange tablets, each containing 0.15 mg levonorgestrel USP
and 0.03 mg ethinyl estradiol USP, and 7 green inert tablets.
This product (like all oral contraceptives) is intended to prevent
pregnancy. It does not protect against HIV infection (AIDS) and
other sexually transmitted diseases.

Rx only 1 Pouch of 28 Tablets
AUROBINDO

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -- 0.15 mg/0.03 mg (28 Tablets Pouch)
(click image for full-size original)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL — 0.15 mg/0.03 mg (168 Tablets Carton)

NDC 65862-848-92
Ayuna®
(levonorgestrel and
ethinyl
estradiol tablets USP)
0.15 mg/0.03 mg

21 orange tablets, each containing 0.15 mg levonorgestrel USP
and 0.03 mg ethinyl estradiol USP, and 7 green inert tablets.

Rx only 6 Pouches of 28 Tablets Each
AUROBINDO

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -- 0.15 mg/0.03 mg (168 Tablets Carton)
(click image for full-size original)

AYUNA levonorgestrel and ethinyl estradiol kit
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65862-848
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:65862-848-88 3 POUCH in 1 CARTON contains a POUCH (65862-848-28)
1 NDC:65862-848-28 1 BLISTER PACK in 1 POUCH This package is contained within the CARTON (65862-848-88) and contains a BLISTER PACK
1 1 KIT in 1 BLISTER PACK This package is contained within a POUCH (65862-848-28) and a CARTON (65862-848-88)
2 NDC:65862-848-92 6 POUCH in 1 CARTON contains a POUCH
2 1 BLISTER PACK in 1 POUCH This package is contained within the CARTON (65862-848-92) and contains a BLISTER PACK
2 1 KIT in 1 BLISTER PACK This package is contained within a POUCH and a CARTON (65862-848-92)
Quantity of Parts
Part # Package Quantity Total Product Quantity
Part 1 21
Part 2 7
Part 1 of 2
AYUNA levonorgestrel and ethinyl estradiol tablet
Product Information
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LEVONORGESTREL (LEVONORGESTREL) LEVONORGESTREL 0.15 mg
ETHINYL ESTRADIOL (ETHINYL ESTRADIOL) ETHINYL ESTRADIOL 0.03 mg
Inactive Ingredients
Ingredient Name Strength
CROSCARMELLOSE SODIUM
FD&C YELLOW NO. 6
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
POVIDONE, UNSPECIFIED
Product Characteristics
Color ORANGE Score no score
Shape ROUND (Biconvex, Beveled Edge) Size 6mm
Flavor Imprint Code S;44
Contains
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA206866 09/23/2016
Part 2 of 2
INERT inert tablet
Product Information
Route of Administration ORAL DEA Schedule
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS LACTOSE
CROSCARMELLOSE SODIUM
FD&C BLUE NO. 2
FERRIC OXIDE YELLOW
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
POVIDONE, UNSPECIFIED
Product Characteristics
Color GREEN Score no score
Shape ROUND (Mottled, Biconvex, Beveled Edge) Size 6mm
Flavor Imprint Code S;61
Contains
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA206866 09/23/2016
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA206866 09/23/2016
Labeler — Aurobindo Pharma Limited (650082092)
Establishment
Name Address ID/FEI Operations
Aurobindo Pharma Limited 650381903 ANALYSIS (65862-848), MANUFACTURE (65862-848)

Revised: 05/2022 Aurobindo Pharma Limited

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