Tydemy (Page 9 of 9)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Tydemy™ (drosperinone, ethinyl estradiol, and levomefolate calcium tablets, 3 mg/0.03 mg/0.451 mg and levomefolate calcium tablets, 0.451 mg)

Rx only

NDC 68180-904-11

Wallet Label: 28 Tablets

image
(click image for full-size original)

Tydemy™ (drosperinone, ethinyl estradiol, and levomefolate calcium tablets, 3 mg/0.03 mg/0.451 mg and levomefolate calcium tablets, 0.451 mg)

Rx only

NDC 68180-904-11

Pouch Label: 1 wallet of 28 Tablets

image
(click image for full-size original)

Tydemy™ (drosperinone, ethinyl estradiol, and levomefolate calcium tablets, 3 mg/0.03 mg/0.451 mg and levomefolate calcium tablets, 0.451 mg)

Rx only

NDC 68180-904-13

Carton Label: 3 wallets each containing 28 Tablets

image
(click image for full-size original)
TYDEMY drospirenone, ethinyl estradiol and levomefolate calcium and levomefolate calcium kit
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68180-904
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68180-904-13 3 POUCH in 1 CARTON contains a POUCH
1 1 BLISTER PACK in 1 POUCH This package is contained within the CARTON (68180-904-13) and contains a BLISTER PACK (68180-904-11)
1 NDC:68180-904-11 1 KIT in 1 BLISTER PACK This package is contained within a POUCH and a CARTON (68180-904-13)
Quantity of Parts
Part # Package Quantity Total Product Quantity
Part 1 21
Part 2 7
Part 1 of 2
TYDEMY drospirenone, ethinyl estradiol and 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 0.03 mg
LEVOMEFOLATE CALCIUM (LEVOMEFOLIC ACID) LEVOMEFOLIC ACID 0.451 mg
Inactive Ingredients
Ingredient Name Strength
ASCORBIC ACID
CROSCARMELLOSE SODIUM
FERRIC OXIDE RED
FERRIC OXIDE YELLOW
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED
HYPROMELLOSES
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
POLYETHYLENE GLYCOL, UNSPECIFIED
STARCH, CORN
TALC
TITANIUM DIOXIDE
Product Characteristics
Color ORANGE Score no score
Shape ROUND Size 6mm
Flavor Imprint Code LU;J63
Contains
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA205948 02/21/2018 11/30/2021
Part 2 of 2
TYDEMY 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) LEVOMEFOLIC ACID 0.451 mg
Inactive Ingredients
Ingredient Name Strength
ASCORBIC ACID
CROSCARMELLOSE SODIUM
FERRIC OXIDE RED
FERRIC OXIDE YELLOW
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED
HYPROMELLOSES
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
POLYETHYLENE GLYCOL, UNSPECIFIED
STARCH, CORN
TALC
TITANIUM DIOXIDE
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 ANDA205948 02/21/2018 11/30/2021
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA205948 02/21/2018 11/30/2021
Labeler — Lupin Pharmaceuticals, Inc. (089153071)
Registrant — LUPIN LIMITED (675923163)
Establishment
Name Address ID/FEI Operations
LUPIN LIMITED 650582310 MANUFACTURE (68180-904), PACK (68180-904)

Revised: 12/2020 Lupin Pharmaceuticals, Inc.

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