Zumandimine (Page 7 of 7)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL — 3 mg/ 0.03 mg Blister Pouch

NDC 59651-030-28
Zumandimine®
(drospirenone and ethinyl estradiol
tablets, USP) 3 mg/0.03 mg

This product (like all oral contraceptives) is intended
to prevent pregnancy. It does not protect against HIV
infection (AIDS) and other sexually transmitted
diseases.

To the Dispenser: This pouch contains patient information
labeling and day label stickers along with the blister pack
intended for the patient. All informational pieces are to be
provided to the patient with each prescription.

Rx only One blister pack of 28 tablets
AUROBINDO

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL -- 3 mg/ 0.03 mg Blister Pouch
(click image for full-size original)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL — 3 mg/ 0.03 mg Pouch Carton

NDC 59651-030-87

Zumandimine®
(drospirenone and ethinyl estradiol
tablets, USP) 3 mg/0.03 mg
This product (like all oral contraceptives) is intended to prevent pregnancy. It
does not protect against HIV infection (AIDS) and other sexually transmitted
diseases.

To the Dispenser: This pouch contains patient information labeling and day label stickers
along with the blister pack intended for the patient. All informational pieces are to be
provided to the patient with each prescription

Rx only One blister pack of 28 tablets. AUROBINDO

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL -- 3 mg/ 0.03 mg Pouch Carton
(click image for full-size original)

ZUMANDIMINE drospirenone and ethinyl estradiol kit
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:59651-030
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:59651-030-87 1 POUCH in 1 CARTON contains a POUCH
1 1 BLISTER PACK in 1 POUCH This package is contained within the CARTON (59651-030-87) and contains a BLISTER PACK
1 1 KIT in 1 BLISTER PACK This package is contained within a POUCH and a CARTON (59651-030-87)
2 NDC:59651-030-88 3 POUCH in 1 CARTON contains a POUCH
2 1 BLISTER PACK in 1 POUCH This package is contained within the CARTON (59651-030-88) and contains a BLISTER PACK
2 1 KIT in 1 BLISTER PACK This package is contained within a POUCH and a CARTON (59651-030-88)
3 NDC:59651-030-28 1 BLISTER PACK in 1 CARTON contains a BLISTER PACK
3 1 KIT in 1 BLISTER PACK This package is contained within the CARTON (59651-030-28)
4 NDC:59651-030-85 3 BLISTER PACK in 1 CARTON contains a BLISTER PACK
4 1 KIT in 1 BLISTER PACK This package is contained within the CARTON (59651-030-85)
Quantity of Parts
Part # Package Quantity Total Product Quantity
Part 1 21
Part 2 7
Part 1 of 2
ZUMANDIMINE drospirenone and ethinyl estradiol tablet
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
Inactive Ingredients
Ingredient Name Strength
STARCH, CORN
FD&C RED NO. 40
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
POVIDONE, UNSPECIFIED
TALC
.ALPHA.-TOCOPHEROL
Product Characteristics
Color PINK (Light Pink to Pink) Score no score
Shape ROUND (Flat Faced, Beveled Edged) Size 6mm
Flavor Imprint Code S;76
Contains
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA209407 03/26/2018
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 (Flat Faced, Beveled Edged) Size 6mm
Flavor Imprint Code S;37
Contains
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA209407 03/26/2018
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA209407 03/26/2018
Labeler — Aurobindo Pharma Limited (650082092)
Establishment
Name Address ID/FEI Operations
Aurobindo Pharma Limited 650381903 ANALYSIS (59651-030), MANUFACTURE (59651-030)

Revised: 05/2022 Aurobindo Pharma Limited

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