OpenRx Open Medications Explorer
© 2026 OpenRx · public-domain U.S. government data
On this page

Loestrin

Norethindrone Acetate and Ethinyl Estradiol and Ferrous Fumarate · Kit

Prescription ANDA TE AB
Informational index, not medical advice. Content is reproduced from public FDA and NLM data. Always confirm against the manufacturer's current prescribing information.

Overview

Brand name
Loestrin Fe 28 Day
Generic name
Norethindrone Acetate and Ethinyl Estradiol and Ferrous Fumarate
Dosage form
Kit
Route
—
Marketing category
ANDA · ANDA
Labeler
Teva Women's Health LLC
Product type
Human Prescription Drug
DEA schedule
Not scheduled
Active ingredients
0
NDC product codes
2
Packages
2
Data completeness
54% of corroborating sources present

Forms, strengths and routes

Source: NDC Directory
Dosage form
Kit
Route of administration
—
Presentations
4

Regulatory status

Source: Drugs@FDANDC Directory
Application number
076064
Application type
ANDA · Abbreviated New Drug Application
Approval date
September 18, 2003
Sponsor
BARR
Products on application
1
Submissions recorded
5
Products approved under application 076064.
Product Trade name Form Strength Ingredient Status TE Flags
076064-001 JUNEL FE 1.5/30 TABLET ETHINYL ESTRADIOL; NORETHINDRONE ACETATE Prescription AB RS

Therapeutic equivalence

Source: Orange Book
TE code
AB
Reference Listed Drug
No
Reference Standard
Yes

What this rating means: Therapeutically equivalent — bioequivalence demonstrated by in vivo or in vitro testing

Codes beginning with “A” indicate products the FDA considers therapeutically equivalent. Codes beginning with “B” indicate bioequivalence has not been established. See methodology.

Approval history

Source: Drugs@FDA
Most recent submissions on application 076064.
Type No. Action Status Date Review
Supplement 30 Labeling Approved September 25, 2023 Standard
Supplement 26 Labeling Approved September 25, 2023 Standard
Supplement 18 Labeling Approved August 18, 2021 Standard
Supplement 3 Labeling Approved October 20, 2004 —
Original application 1 Approved September 18, 2003 —

Packaging and NDCs

Source: NDC Directory
Every National Drug Code package associated with this medication. The NDC is the identifier used for dispensing, billing and pharmacovigilance in the United States.
Package NDC Product NDC Labeler Description Marketing start
51285-125-70 51285-125 Teva Women's Health LLC 5 POUCH in 1 CARTON (51285-125-70) / 1 BLISTER PACK in 1 POUCH / 1 KIT in 1 BLISTER PACK February 26, 2015
51285-128-70 51285-128 Teva Women's Health LLC 5 POUCH in 1 CARTON (51285-128-70) / 1 BLISTER PACK in 1 POUCH / 1 KIT in 1 BLISTER PACK February 26, 2015
51285-125 51285-125 Teva Women's Health LLC — February 26, 2015
51285-128 51285-128 Teva Women's Health LLC — February 26, 2015

Sources for this page

Every dataset that contributed a fact to this page.
Dataset Agency Used for
NDC Directory FDA Identity, ingredients, strengths, forms, routes, labelers, packages
Drugs@FDA FDA Application, sponsor, submissions, review documents, marketing status
Orange Book FDA Therapeutic equivalence codes, reference drug flags, patents, exclusivity

Generated September 25, 2026 · 8 sections on this page.