loestrin fe 28 day

Generic: norethindrone acetate and ethinyl estradiol and ferrous fumarate

Labeler: teva women's health llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name loestrin fe 28 day
Generic Name norethindrone acetate and ethinyl estradiol and ferrous fumarate
Labeler teva women's health llc
Dosage Form KIT
Manufacturer
Teva Women's Health LLC

Identifiers & Regulatory

Product NDC 51285-128
Product ID 51285-128_21f0dbf2-f0a8-447a-a975-482b4194b1eb
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA076064
Listing Expiration 2026-12-31
Marketing Start 2015-02-26

Pharmacologic Class

Established (EPC)
estrogen [epc]
Mechanism of Action
estrogen receptor agonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 51285128
Hyphenated Format 51285-128

Supplemental Identifiers

RxCUI
259176 1358762 1358763 1358770 1358776 1358781 1359022 1359023 1359026 1359028 1359031
UNII
9S44LIC7OJ 423D2T571U
NUI
N0000175825 N0000000100

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name loestrin fe 28 day (source: ndc)
Generic Name norethindrone acetate and ethinyl estradiol and ferrous fumarate (source: ndc)
Application Number ANDA076064 (source: ndc)
Routes
oral
source: label

Resolved Composition

Strengths
  • 1 mg
  • 20 mcg
  • 75 mg
  • 1.5 mg
  • 30 mcg
source: label
Packaging
  • 5 POUCH in 1 CARTON (51285-128-70) / 1 BLISTER PACK in 1 POUCH / 1 KIT in 1 BLISTER PACK
source: ndc

Packages (1)

51285-128-70 5 POUCH in 1 CARTON (51285-128-70) / 1 BLISTER PACK in 1 POUCH / 1 KIT in 1 BLISTER PACK

Ingredients (0)

No ingredient records.

Linked Drug Pages (1)

Loestrin Fe 28 Day, Loestrin 21 Day ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"spl_id": "21f0dbf2-f0a8-447a-a975-482b4194b1eb", "openfda": {"nui": ["N0000175825", "N0000000100"], "unii": ["9S44LIC7OJ", "423D2T571U"], "rxcui": ["259176", "1358762", "1358763", "1358770", "1358776", "1358781", "1359022", "1359023", "1359026", "1359028", "1359031"], "spl_set_id": ["f29ebcb5-7e65-4092-bfaa-f5ec026fc255"], "pharm_class_epc": ["Estrogen [EPC]"], "pharm_class_moa": ["Estrogen Receptor Agonists [MoA]"], "manufacturer_name": ["Teva Women's Health LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "5 POUCH in 1 CARTON (51285-128-70)  / 1 BLISTER PACK in 1 POUCH / 1 KIT in 1 BLISTER PACK", "package_ndc": "51285-128-70", "marketing_start_date": "20150226"}], "brand_name": "Loestrin Fe 28 Day", "product_id": "51285-128_21f0dbf2-f0a8-447a-a975-482b4194b1eb", "dosage_form": "KIT", "product_ndc": "51285-128", "generic_name": "Norethindrone Acetate and Ethinyl Estradiol and Ferrous Fumarate", "labeler_name": "Teva Women's Health LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Loestrin", "brand_name_suffix": "Fe 28 Day", "application_number": "ANDA076064", "marketing_category": "ANDA", "marketing_start_date": "20150226", "listing_expiration_date": "20261231"}