Prescription Drug Information: Microgestin 1/20 (Page 7 of 7)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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MICROGESTIN 1/20
norethindrone acetate/ethinyl estradiol kit
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:51862-868
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:51862-868-01 1 BLISTER PACK in 1 PACKET contains a BLISTER PACK
1 1 KIT in 1 BLISTER PACK This package is contained within the PACKET (51862-868-01)
2 NDC:51862-868-02 1 BLISTER PACK in 1 CARTON contains a BLISTER PACK
2 1 KIT in 1 BLISTER PACK This package is contained within the CARTON (51862-868-02)
3 NDC:51862-868-03 3 BLISTER PACK in 1 CARTON contains a BLISTER PACK
3 1 KIT in 1 BLISTER PACK This package is contained within the CARTON (51862-868-03)
4 NDC:51862-868-06 6 BLISTER PACK in 1 CARTON contains a BLISTER PACK
4 1 KIT in 1 BLISTER PACK This package is contained within the CARTON (51862-868-06)
Quantity of Parts
Part # Package Quantity Total Product Quantity
Part 1 21
Part 1 of 1
MICROGESTIN 1/20
norethindrone acetate and ethinyl estradiol tablet
Product Information
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
NORETHINDRONE ACETATE (NORETHINDRONE) NORETHINDRONE ACETATE 1 mg
ETHINYL ESTRADIOL (ETHINYL ESTRADIOL) ETHINYL ESTRADIOL 0.02 mg
Inactive Ingredients
Ingredient Name Strength
POLYVINYL ALCOHOL
TITANIUM DIOXIDE
TALC
POLYETHYLENE GLYCOL 3350
LECITHIN, SOYBEAN
D&C YELLOW NO. 10
FD&C BLUE NO. 2
FD&C YELLOW NO. 6
LACTOSE
MAGNESIUM STEARATE
STARCH, PREGELATINIZED CORN
Product Characteristics
Color YELLOW (pale) Score no score
Shape ROUND (biconvex) Size 5mm
Flavor Imprint Code L2
Contains
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA202995 10/12/2020
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA202995 10/12/2020
Labeler — Mayne Pharma Inc. (867220261)
Registrant — Novast Laboratories, Ltd. (527695995)
Establishment
Name Address ID/FEI Operations
Novast Laboratories, Ltd. 527695995 analysis (51862-868), label (51862-868), manufacture (51862-868), pack (51862-868)

Revised: 10/2020 Mayne Pharma Inc.

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