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Microgestin Fe

MICROGESTIN 1/20 (Norethindrone Acetate and Ethinyl Estradiol Tablets USP) MICROGESTIN Fe 1/20 (Norethindrone Acetate and Ethinyl Estradiol Tablets USP and Ferrous Fumarate Tablets*) *Ferrous fumarate tablets are not USP for dissolution and assay. MICROGESTIN 1.5/30 (Norethindrone Acetate and Ethinyl Estradiol Tablets USP) MICROGESTIN Fe 1.5/30 (Norethindrone Acetate and Ethinyl Estradiol Tablets USP and Ferrous Fumarate Tablets*) *Ferrous fumarate tablets are not USP for dissolution and assay. Rx only Revised: October 2007 14786

Approved
Approval ID

54262321-1af5-4433-88c6-4409ff428079

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Apr 26, 2012

Manufacturers
FDA

Physicians Total Care, Inc.

DUNS: 194123980

Products 2

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

Norethindrone Acetate and Ethinyl Estradiol

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code54868-6213
Application NumberANDA075647
Product Classification
M
Marketing Category
C73584
G
Generic Name
Norethindrone Acetate and Ethinyl Estradiol
Product Specifications
Route of AdministrationORAL
Effective DateApril 26, 2012
FDA Product Classification

INGREDIENTS (8)

ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
NORETHINDRONE ACETATEActive
Quantity: 1.0 mg in 1 1
Code: 9S44LIC7OJ
Classification: ACTIB
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
POLACRILIN POTASSIUMInactive
Code: 0BZ5A00FQU
Classification: IACT
ETHINYL ESTRADIOLActive
Quantity: 0.02 mg in 1 1
Code: 423D2T571U
Classification: ACTIB
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT

Norethindrone Acetate and Ethinyl Estradiol and Ferrous Fumarate

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code54868-4744
Application NumberANDA075647
Product Classification
M
Marketing Category
C73584
G
Generic Name
Norethindrone Acetate and Ethinyl Estradiol and Ferrous Fumarate
Product Specifications
Effective DateApril 26, 2012
FDA Product Classification

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Microgestin Fe - FDA Drug Approval Details