norethindrone acetate

Generic: norethindrone

Labeler: avkare
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name norethindrone acetate
Generic Name norethindrone
Labeler avkare
Dosage Form TABLET
Routes
ORAL
Active Ingredients

norethindrone acetate 5 mg/1

Manufacturer
AvKARE

Identifiers & Regulatory

Product NDC 42291-650
Product ID 42291-650_3f07bf1f-a9bc-c5ad-e063-6394a90a7545
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA200275
Listing Expiration 2026-12-31
Marketing Start 2013-06-18

Pharmacologic Class

Classes
progesterone congeners [cs] progestin [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 42291650
Hyphenated Format 42291-650

Supplemental Identifiers

RxCUI
1000405
UNII
9S44LIC7OJ

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 (source: ndc)
Application Number ANDA200275 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 90 TABLET in 1 BOTTLE (42291-650-90)
source: ndc

Packages (1)

42291-650-90 90 TABLET in 1 BOTTLE (42291-650-90)

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": "3f07bf1f-a9bc-c5ad-e063-6394a90a7545", "openfda": {"unii": ["9S44LIC7OJ"], "rxcui": ["1000405"], "spl_set_id": ["827c7ef1-a8b7-d0c4-b062-c5154b331a35"], "manufacturer_name": ["AvKARE"]}, "finished": true, "packaging": [{"sample": false, "description": "90 TABLET in 1 BOTTLE (42291-650-90)", "package_ndc": "42291-650-90", "marketing_start_date": "20130618"}], "brand_name": "Norethindrone Acetate", "product_id": "42291-650_3f07bf1f-a9bc-c5ad-e063-6394a90a7545", "dosage_form": "TABLET", "pharm_class": ["Progesterone Congeners [CS]", "Progestin [EPC]"], "product_ndc": "42291-650", "generic_name": "Norethindrone", "labeler_name": "AvKARE", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Norethindrone Acetate", "active_ingredients": [{"name": "NORETHINDRONE ACETATE", "strength": "5 mg/1"}], "application_number": "ANDA200275", "marketing_category": "ANDA", "marketing_start_date": "20130618", "listing_expiration_date": "20261231"}