Prescription Drug Information: DROSPIRENONE, ETHINYL ESTRADIOL AND LEVOMEFOLATE CALCIUM AND LEVOMEFOLATE CALCIUM (Page 8 of 8)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Drospirenone, Ethinyl Estradiol and Levomefolate Calcium Tablets and Levomefolate Calcium Tablets

NDC 68180-894-73

3 blisters of 28 tablets each

Rx Only

Carton Label
(click image for full-size original)

Drospirenone, Ethinyl Estradiol and Levomefolate Calcium Tablets and Levomefolate Calcium Tablets

NDC 68180-894-71

1 blister of 28 tablets each

Rx Only

Pouch Label
(click image for full-size original)

Drospirenone, Ethinyl Estradiol and Levomefolate Calcium Tablets and Levomefolate Calcium Tablets

NDC 68180-894-71

28 tablets

Rx Only

Blister Label
(click image for full-size original)
DROSPIRENONE, ETHINYL ESTRADIOL AND LEVOMEFOLATE CALCIUM AND LEVOMEFOLATE CALCIUM drospirenone, ethinyl estradiol and levomefolate calcium and levomefolate calcium kit
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68180-894
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68180-894-73 3 POUCH in 1 CARTON contains a POUCH
1 1 BLISTER PACK in 1 POUCH This package is contained within the CARTON (68180-894-73) and contains a BLISTER PACK (68180-894-71)
1 NDC:68180-894-71 1 KIT in 1 BLISTER PACK This package is contained within a POUCH and a CARTON (68180-894-73)
Quantity of Parts
Part # Package Quantity Total Product Quantity
Part 1 24
Part 2 4
Part 1 of 2
DROSPIRENONE, ETHINYL ESTRADIOL, LEVOMEFOLATE CALCIUM drospirenone, ethinyl estradiol, levomefolate calcium tablet, film coated
Product Information
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DROSPIRENONE (DROSPIRENONE) DROSPIRENONE 3 mg
ETHINYL ESTRADIOL (ETHINYL ESTRADIOL) ETHINYL ESTRADIOL 0.02 mg
LEVOMEFOLATE CALCIUM (LEVOMEFOLIC ACID) LEVOMEFOLATE CALCIUM 0.451 mg
Inactive Ingredients
Ingredient Name Strength
ASCORBIC ACID
CROSCARMELLOSE SODIUM
FERRIC OXIDE RED
HYPROMELLOSES
LACTOSE MONOHYDRATE
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED
MAGNESIUM STEARATE
TALC
TITANIUM DIOXIDE
POLYETHYLENE GLYCOL, UNSPECIFIED
STARCH, CORN
Product Characteristics
Color PINK Score no score
Shape ROUND Size 6mm
Flavor Imprint Code LU;J61
Contains
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA205947 11/17/2020
Part 2 of 2
LEVOMEFOLATE CALCIUM levomefolate calcium tablet, film coated
Product Information
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LEVOMEFOLATE CALCIUM (LEVOMEFOLIC ACID) LEVOMEFOLATE CALCIUM 0.451
Inactive Ingredients
Ingredient Name Strength
ASCORBIC ACID
CROSCARMELLOSE SODIUM
FERRIC OXIDE YELLOW
FERRIC OXIDE RED
HYPROMELLOSES
LACTOSE MONOHYDRATE
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED
MAGNESIUM STEARATE
TALC
TITANIUM DIOXIDE
POLYETHYLENE GLYCOL, UNSPECIFIED
STARCH, CORN
Product Characteristics
Color ORANGE (LIGHT ORANGE) Score no score
Shape ROUND Size 6mm
Flavor Imprint Code LU;J62
Contains
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA205947 11/17/2020
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA205947 11/17/2020
Labeler — Lupin Pharmaceuticals, Inc. (089153071)
Registrant — LUPIN LIMITED (675923163)
Establishment
Name Address ID/FEI Operations
LUPIN LIMITED 650582310 MANUFACTURE (68180-894)

Revised: 11/2020 Lupin Pharmaceuticals, Inc.

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