MedPath

Loestrin

LOESTRIN 21 Day (norethindrone acetate and ethinyl estradiol tablets USP)LOESTRIN Fe 28 Day(norethindrone acetate and ethinyl estradiol tablets USP and ferrous fumarate tablets*)*Ferrous fumarate tablets are not USP for dissolution and assay.

Approved
Approval ID

f29ebcb5-7e65-4092-bfaa-f5ec026fc255

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Aug 30, 2023

Manufacturers
FDA

Teva Women's Health LLC

DUNS: 017038951

Products 4

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 Code51285-127
Application NumberANDA076381
Product Classification
M
Marketing Category
C73584
G
Generic Name
Norethindrone Acetate and Ethinyl Estradiol
Product Specifications
Route of AdministrationORAL
Effective DateAugust 30, 2023
FDA Product Classification

INGREDIENTS (9)

NORETHINDRONE ACETATEActive
Quantity: 1.5 mg in 1 1
Code: 9S44LIC7OJ
Classification: ACTIB
ETHINYL ESTRADIOLActive
Quantity: 30 ug in 1 1
Code: 423D2T571U
Classification: ACTIB
ACACIAInactive
Code: 5C5403N26O
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
MALTODEXTRINInactive
Code: 7CVR7L4A2D
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT

Norethindrone Acetate and Ethinyl Estradiol

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code51285-131
Application NumberANDA076380
Product Classification
M
Marketing Category
C73584
G
Generic Name
Norethindrone Acetate and Ethinyl Estradiol
Product Specifications
Route of AdministrationORAL
Effective DateAugust 30, 2023
FDA Product Classification

INGREDIENTS (9)

NORETHINDRONE ACETATEActive
Quantity: 1 mg in 1 1
Code: 9S44LIC7OJ
Classification: ACTIB
ETHINYL ESTRADIOLActive
Quantity: 20 ug in 1 1
Code: 423D2T571U
Classification: ACTIB
ACACIAInactive
Code: 5C5403N26O
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
MALTODEXTRINInactive
Code: 7CVR7L4A2D
Classification: IACT
D&C YELLOW NO. 10 ALUMINUM LAKEInactive
Code: CQ3XH3DET6
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT

Norethindrone Acetate and Ethinyl Estradiol and Ferrous Fumarate

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code51285-128
Application NumberANDA076064
Product Classification
M
Marketing Category
C73584
G
Generic Name
Norethindrone Acetate and Ethinyl Estradiol and Ferrous Fumarate
Product Specifications
Effective DateAugust 30, 2023
FDA Product Classification

Norethindrone Acetate and Ethinyl Estradiol and Ferrous Fumarate

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code51285-125
Application NumberANDA076081
Product Classification
M
Marketing Category
C73584
G
Generic Name
Norethindrone Acetate and Ethinyl Estradiol and Ferrous Fumarate
Product Specifications
Effective DateAugust 30, 2023
FDA Product Classification

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.

Loestrin - FDA Drug Approval Details