loestrin 21 day (51285-127)

Drug Facts

Product Profile

Brand Name loestrin 21 day

Generic Name norethindrone acetate and ethinyl estradiol

Labeler teva women's health llc

Dosage Form TABLET

Routes

ORAL

Active Ingredients

ethinyl estradiol 30 ug/1, norethindrone acetate 1.5 mg/1

Manufacturer

Teva Women's Health LLC

Identifiers & Regulatory

Product NDC 51285-127

Product ID 51285-127_21f0dbf2-f0a8-447a-a975-482b4194b1eb

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA076381

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 51285127

Hyphenated Format 51285-127

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 21 day (source: ndc)

Generic Name norethindrone acetate and ethinyl estradiol (source: ndc)

Application Number ANDA076381 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

30 ug/1
1.5 mg/1

source: ndc

Packaging

5 POUCH in 1 CARTON (51285-127-97) / 1 BLISTER PACK in 1 POUCH / 21 TABLET in 1 BLISTER PACK

source: ndc

Packages (1)

51285-127-97 5 POUCH in 1 CARTON (51285-127-97) / 1 BLISTER PACK in 1 POUCH / 21 TABLET in 1 BLISTER PACK

Ingredients (2)

ethinyl estradiol (30 ug/1) norethindrone acetate (1.5 mg/1)

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

{"route": ["ORAL"], "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 (51285-127-97)  / 1 BLISTER PACK in 1 POUCH / 21 TABLET in 1 BLISTER PACK", "package_ndc": "51285-127-97", "marketing_start_date": "20150226"}], "brand_name": "Loestrin 21 Day", "product_id": "51285-127_21f0dbf2-f0a8-447a-a975-482b4194b1eb", "dosage_form": "TABLET", "pharm_class": ["Estrogen Receptor Agonists [MoA]", "Estrogen [EPC]", "Progesterone Congeners [CS]", "Progestin [EPC]"], "product_ndc": "51285-127", "generic_name": "Norethindrone Acetate and Ethinyl Estradiol", "labeler_name": "Teva Women's Health LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Loestrin", "brand_name_suffix": "21 Day", "active_ingredients": [{"name": "ETHINYL ESTRADIOL", "strength": "30 ug/1"}, {"name": "NORETHINDRONE ACETATE", "strength": "1.5 mg/1"}], "application_number": "ANDA076381", "marketing_category": "ANDA", "marketing_start_date": "20150226", "listing_expiration_date": "20261231"}