estradiol / norethindrone acetate (51991-474)

Drug Facts

Product Profile

Brand Name estradiol / norethindrone acetate

Generic Name estradiol and norethindrone acetate

Labeler breckenridge pharmaceutical, inc.

Dosage Form TABLET, FILM COATED

Routes

ORAL

Active Ingredients

estradiol 1 mg/1, norethindrone acetate .5 mg/1

Manufacturer

Breckenridge Pharmaceutical, Inc.

Identifiers & Regulatory

Product NDC 51991-474

Product ID 51991-474_d0f8f0e6-e2b1-40ff-8b4b-0ed8a7525689

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA078324

Listing Expiration 2026-12-31

Marketing Start 2008-04-17

Pharmacologic Class

Established (EPC)

estrogen [epc]

Mechanism of Action

estrogen receptor agonists [moa]

Chemical Structure

estradiol congeners [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 51991474

Hyphenated Format 51991-474

Supplemental Identifiers

RxCUI

1359123 1359124 1359126 1359127

UNII

9S44LIC7OJ 4TI98Z838E

NUI

M0447348 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 estradiol / norethindrone acetate (source: ndc)

Generic Name estradiol and norethindrone acetate (source: ndc)

Application Number ANDA078324 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

1 mg/1
.5 mg/1

source: ndc

Packaging

1 BLISTER PACK in 1 CARTON (51991-474-28) / 28 TABLET, FILM COATED in 1 BLISTER PACK

source: ndc

Packages (1)

51991-474-28 1 BLISTER PACK in 1 CARTON (51991-474-28) / 28 TABLET, FILM COATED in 1 BLISTER PACK

Ingredients (2)

estradiol (1 mg/1) norethindrone acetate (.5 mg/1)

Linked Drug Pages (1)

Estradiol / Norethindrone Acetate ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload

{"route": ["ORAL"], "spl_id": "d0f8f0e6-e2b1-40ff-8b4b-0ed8a7525689", "openfda": {"nui": ["M0447348", "N0000175825", "N0000000100"], "unii": ["9S44LIC7OJ", "4TI98Z838E"], "rxcui": ["1359123", "1359124", "1359126", "1359127"], "spl_set_id": ["44125b2f-10ac-435c-bdb4-a29bf8450dbf"], "pharm_class_cs": ["Estradiol Congeners [CS]"], "pharm_class_epc": ["Estrogen [EPC]"], "pharm_class_moa": ["Estrogen Receptor Agonists [MoA]"], "manufacturer_name": ["Breckenridge Pharmaceutical, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BLISTER PACK in 1 CARTON (51991-474-28)  / 28 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "51991-474-28", "marketing_start_date": "20080417"}], "brand_name": "Estradiol / Norethindrone Acetate", "product_id": "51991-474_d0f8f0e6-e2b1-40ff-8b4b-0ed8a7525689", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Estradiol Congeners [CS]", "Estrogen Receptor Agonists [MoA]", "Estrogen [EPC]", "Progesterone Congeners [CS]", "Progestin [EPC]"], "product_ndc": "51991-474", "generic_name": "Estradiol and Norethindrone Acetate", "labeler_name": "Breckenridge Pharmaceutical, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Estradiol / Norethindrone Acetate", "active_ingredients": [{"name": "ESTRADIOL", "strength": "1 mg/1"}, {"name": "NORETHINDRONE ACETATE", "strength": ".5 mg/1"}], "application_number": "ANDA078324", "marketing_category": "ANDA", "marketing_start_date": "20080417", "listing_expiration_date": "20261231"}