norethindrone acetate

Generic: norethindrone acetate

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

Drug Facts

Product Profile

Brand Name norethindrone acetate
Generic Name norethindrone acetate
Labeler ingenus pharmaceuticals, llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

norethindrone acetate 5 mg/1

Manufacturer
Ingenus Pharmaceuticals, LLC

Identifiers & Regulatory

Product NDC 50742-267
Product ID 50742-267_ec08066e-8299-493e-b502-e56db778b15e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA206490
Listing Expiration 2026-12-31
Marketing Start 2019-08-29

Pharmacologic Class

Classes
progesterone congeners [cs] progestin [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 50742267
Hyphenated Format 50742-267

Supplemental Identifiers

RxCUI
1000405
UPC
0350742267507
UNII
9S44LIC7OJ

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 norethindrone acetate (source: ndc)
Generic Name norethindrone acetate (source: ndc)
Application Number ANDA206490 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 50 TABLET in 1 BOTTLE (50742-267-50)
source: ndc

Packages (1)

50742-267-50 50 TABLET in 1 BOTTLE (50742-267-50)

Ingredients (1)

norethindrone acetate (5 mg/1)

Linked Drug Pages (1)

Norethindrone acetate ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "ec08066e-8299-493e-b502-e56db778b15e", "openfda": {"upc": ["0350742267507"], "unii": ["9S44LIC7OJ"], "rxcui": ["1000405"], "spl_set_id": ["2f39b608-cc62-4ff0-a52a-bc3343275269"], "manufacturer_name": ["Ingenus Pharmaceuticals, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "50 TABLET in 1 BOTTLE (50742-267-50)", "package_ndc": "50742-267-50", "marketing_start_date": "20190829"}], "brand_name": "Norethindrone acetate", "product_id": "50742-267_ec08066e-8299-493e-b502-e56db778b15e", "dosage_form": "TABLET", "pharm_class": ["Progesterone Congeners [CS]", "Progestin [EPC]"], "product_ndc": "50742-267", "generic_name": "norethindrone acetate", "labeler_name": "Ingenus Pharmaceuticals, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Norethindrone acetate", "active_ingredients": [{"name": "NORETHINDRONE ACETATE", "strength": "5 mg/1"}], "application_number": "ANDA206490", "marketing_category": "ANDA", "marketing_start_date": "20190829", "listing_expiration_date": "20261231"}