Bekyree (Page 6 of 6)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Bekyree™

desogestrel and ethinyl estradiol tablets USP, 0.15 mg/0.02 mg and ethinyl estradiol tablets USP,0.01 mg

NDC 68180-880-11

Wallet Label: 28 Tablets

Bekyree
(desogestrel and ethinyl estradiol tablets USP (0.15 mg/0.02 mg) and ethinyl estradiol tablets (0.01 mg)]
NDC 68180-880-11
																											Wallet Label: 28 Tablets
(click image for full-size original)

Bekyree™

desogestrel and ethinyl estradiol tablets USP, 0.15 mg/0.02 mg and ethinyl estradiol tablets USP,0.01 mg

NDC 68180-880-11

Pouch Label: 1 Wallet of 28 Tablets

Bekyree
(desogestrel and ethinyl estradiol tablets USP (0.15 mg/0.02 mg) and ethinyl estradiol tablets (0.01 mg)]
NDC 68180-880-11
																											Pouch Label: 1 Wallet of 28 Tablets
(click image for full-size original)

Bekyree™

desogestrel and ethinyl estradiol tablets USP, 0.15 mg/0.02 mg and ethinyl estradiol tablets USP,0.01 mg

NDC 68180-880-13

Carton Label: 3 Wallets of 28 Tablets each

Bekyree
(desogestrel and ethinyl estradiol tablets USP (0.15 mg/0.02 mg) and ethinyl estradiol tablets (0.01 mg)]
NDC 68180-880-13
																											Carton Label: 3 Wallets of 28 Tablets each
(click image for full-size original)
BEKYREE desogestrel and ethinyl estradiol and ethinyl estradiol kit
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:57297-880
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:57297-880-13 3 POUCH in 1 CARTON contains a POUCH (57297-880-11)
1 NDC:57297-880-11 1 KIT in 1 POUCH This package is contained within the CARTON (57297-880-13)
Quantity of Parts
Part # Package Quantity Total Product Quantity
Part 1 21
Part 2 2
Part 3 5
Part 1 of 3
BEKYREE desogestrel and ethinyl estradiol tablet, film coated
Product Information
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ETHINYL ESTRADIOL (ETHINYL ESTRADIOL) ETHINYL ESTRADIOL 0.02 mg
DESOGESTREL (DESOGESTREL) DESOGESTREL 0.15 mg
Inactive Ingredients
Ingredient Name Strength
HYPROMELLOSES
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
POLYETHYLENE GLYCOL 400
POVIDONES
SILICON DIOXIDE
STARCH, CORN
STEARIC ACID
TALC
TITANIUM DIOXIDE
TOCOPHEROL
Product Characteristics
Color WHITE (white) Score no score
Shape ROUND (Biconvex) Size 5mm
Flavor Imprint Code LU;K21
Contains
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA202226 10/26/2015
Part 2 of 3
BEKYREE inert tablet, film coated
Product Information
Route of Administration ORAL DEA Schedule
Inactive Ingredients
Ingredient Name Strength
ALUMINUM OXIDE
D&C YELLOW NO. 10
FD&C BLUE NO. 2
FD&C YELLOW NO. 6
HYPROMELLOSES
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
POLYETHYLENE GLYCOL 400
STARCH, CORN
TITANIUM DIOXIDE
Product Characteristics
Color GREEN (green) Score no score
Shape ROUND (BICONVEX) Size 5mm
Flavor Imprint Code LU;L22
Contains
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA202226 10/26/2015
Part 3 of 3
BEKYREE ethinyl estradiol tablet, film coated
Product Information
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ETHINYL ESTRADIOL (ETHINYL ESTRADIOL) ETHINYL ESTRADIOL 0.01 mg
Inactive Ingredients
Ingredient Name Strength
FD&C YELLOW NO. 5
FERRIC OXIDE YELLOW
HYPROMELLOSES
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
POLYETHYLENE GLYCOL 400
POVIDONES
SILICON DIOXIDE
STARCH, CORN
STEARIC ACID
TALC
TITANIUM DIOXIDE
TOCOPHEROL
ALUMINUM OXIDE
Product Characteristics
Color YELLOW (yellow) Score no score
Shape ROUND (biconvex) Size 5mm
Flavor Imprint Code LU;K22
Contains
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA202226 10/26/2015
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA202226 10/26/2015
Labeler — LUPIN LIMITED (675923163)
Registrant — LUPIN LIMITED (675923163)
Establishment
Name Address ID/FEI Operations
LUPIN LIMITED 650582310 manufacture (57297-880), pack (57297-880)

Revised: 05/2016 LUPIN LIMITED

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