estradiol and norethindrone acetate (50742-658)

Drug Facts

Product Profile

Brand Name estradiol and norethindrone acetate

Generic Name estradiol and norethindrone acetate

Labeler ingenus pharmaceuticals, llc

Dosage Form TABLET

Routes

ORAL

Active Ingredients

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

Manufacturer

Ingenus Pharmaceuticals, LLC

Identifiers & Regulatory

Product NDC 50742-658

Product ID 50742-658_e285b638-ef6a-40f1-9fc9-206dac35cb9f

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA210612

Listing Expiration 2026-12-31

Marketing Start 2019-04-03

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 50742658

Hyphenated Format 50742-658

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 and norethindrone acetate (source: ndc)

Generic Name estradiol and norethindrone acetate (source: ndc)

Application Number ANDA210612 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

.5 mg/1
.1 mg/1

source: ndc

Packaging

1 BLISTER PACK in 1 CARTON (50742-658-28) / 28 TABLET in 1 BLISTER PACK (50742-658-01)
6 BLISTER PACK in 1 CARTON (50742-658-68) / 28 TABLET in 1 BLISTER PACK (50742-658-01)
3 BLISTER PACK in 1 CARTON (50742-658-84) / 28 TABLET in 1 BLISTER PACK (50742-658-01)

source: ndc

Packages (3)

50742-658-28 1 BLISTER PACK in 1 CARTON (50742-658-28) / 28 TABLET in 1 BLISTER PACK (50742-658-01) 50742-658-68 6 BLISTER PACK in 1 CARTON (50742-658-68) / 28 TABLET in 1 BLISTER PACK (50742-658-01) 50742-658-84 3 BLISTER PACK in 1 CARTON (50742-658-84) / 28 TABLET in 1 BLISTER PACK (50742-658-01)

Ingredients (2)

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

Linked Drug Pages (1)

Estradiol and Norethindrone Acetate ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload

{"route": ["ORAL"], "spl_id": "e285b638-ef6a-40f1-9fc9-206dac35cb9f", "openfda": {"nui": ["M0447348", "N0000175825", "N0000000100"], "unii": ["9S44LIC7OJ", "4TI98Z838E"], "rxcui": ["1359123", "1359124", "1359126", "1359127"], "spl_set_id": ["50c786d6-91bd-4eea-9455-ff2abc08372f"], "pharm_class_cs": ["Estradiol Congeners [CS]"], "pharm_class_epc": ["Estrogen [EPC]"], "pharm_class_moa": ["Estrogen Receptor Agonists [MoA]"], "manufacturer_name": ["Ingenus Pharmaceuticals, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BLISTER PACK in 1 CARTON (50742-658-28)  / 28 TABLET in 1 BLISTER PACK (50742-658-01)", "package_ndc": "50742-658-28", "marketing_start_date": "20190403"}, {"sample": false, "description": "6 BLISTER PACK in 1 CARTON (50742-658-68)  / 28 TABLET in 1 BLISTER PACK (50742-658-01)", "package_ndc": "50742-658-68", "marketing_start_date": "20190403"}, {"sample": false, "description": "3 BLISTER PACK in 1 CARTON (50742-658-84)  / 28 TABLET in 1 BLISTER PACK (50742-658-01)", "package_ndc": "50742-658-84", "marketing_start_date": "20190403"}], "brand_name": "Estradiol and Norethindrone Acetate", "product_id": "50742-658_e285b638-ef6a-40f1-9fc9-206dac35cb9f", "dosage_form": "TABLET", "pharm_class": ["Estradiol Congeners [CS]", "Estrogen Receptor Agonists [MoA]", "Estrogen [EPC]", "Progesterone Congeners [CS]", "Progestin [EPC]"], "product_ndc": "50742-658", "generic_name": "Estradiol and Norethindrone Acetate", "labeler_name": "Ingenus Pharmaceuticals, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Estradiol and Norethindrone Acetate", "active_ingredients": [{"name": "ESTRADIOL", "strength": ".5 mg/1"}, {"name": "NORETHINDRONE ACETATE", "strength": ".1 mg/1"}], "application_number": "ANDA210612", "marketing_category": "ANDA", "marketing_start_date": "20190403", "listing_expiration_date": "20261231"}