estradiol and norethindrone acetate

Generic: estradiol and norethindrone acetate

Labeler: ingenus pharmaceuticals, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

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

Manufacturer
Ingenus Pharmaceuticals, LLC

Identifiers & Regulatory

Product NDC 50742-657
Product ID 50742-657_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 50742657
Hyphenated Format 50742-657

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
  • 1 mg/1
  • .5 mg/1
source: ndc
Packaging
  • 1 BLISTER PACK in 1 CARTON (50742-657-28) / 28 TABLET in 1 BLISTER PACK (50742-657-01)
  • 6 BLISTER PACK in 1 CARTON (50742-657-68) / 28 TABLET in 1 BLISTER PACK (50742-657-01)
  • 3 BLISTER PACK in 1 CARTON (50742-657-84) / 28 TABLET in 1 BLISTER PACK (50742-657-01)
source: ndc

Packages (3)

50742-657-28 1 BLISTER PACK in 1 CARTON (50742-657-28) / 28 TABLET in 1 BLISTER PACK (50742-657-01) 50742-657-68 6 BLISTER PACK in 1 CARTON (50742-657-68) / 28 TABLET in 1 BLISTER PACK (50742-657-01) 50742-657-84 3 BLISTER PACK in 1 CARTON (50742-657-84) / 28 TABLET in 1 BLISTER PACK (50742-657-01)

Ingredients (2)

estradiol (1 mg/1) norethindrone acetate (.5 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 (50742-657-28)  / 28 TABLET in 1 BLISTER PACK (50742-657-01)", "package_ndc": "50742-657-28", "marketing_start_date": "20190403"}, {"sample": false, "description": "6 BLISTER PACK in 1 CARTON (50742-657-68)  / 28 TABLET in 1 BLISTER PACK (50742-657-01)", "package_ndc": "50742-657-68", "marketing_start_date": "20190403"}, {"sample": false, "description": "3 BLISTER PACK in 1 CARTON (50742-657-84)  / 28 TABLET in 1 BLISTER PACK (50742-657-01)", "package_ndc": "50742-657-84", "marketing_start_date": "20190403"}], "brand_name": "Estradiol and Norethindrone Acetate", "product_id": "50742-657_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": "50742-657", "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": "1 mg/1"}, {"name": "NORETHINDRONE ACETATE", "strength": ".5 mg/1"}], "application_number": "ANDA210612", "marketing_category": "ANDA", "marketing_start_date": "20190403", "listing_expiration_date": "20261231"}