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Microgestin Fe 1/20

Microgestin® Fe 1/20(Norethindrone Acetate and Ethinyl Estradiol Tablets, USP and Ferrous Fumarate Tablets*)*Ferrous fumarate tablets are not USP for dissolution.

Approved
Approval ID

9bff0c82-55b0-4eea-9c91-534341be0a05

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Apr 20, 2022

Manufacturers
FDA

RPK Pharmaceuticals, Inc.

DUNS: 147096275

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Norethindrone Acetate/Ethinyl Estradiol and Ferrous Fumarate

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code53002-2616
Application NumberANDA091454
Product Classification
M
Marketing Category
C73584
G
Generic Name
Norethindrone Acetate/Ethinyl Estradiol and Ferrous Fumarate
Product Specifications
Effective DateOctober 12, 2020
FDA Product Classification

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Microgestin Fe 1/20 - FDA Drug Approval Details