norethindrone acetate

Generic: norethindrone

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

Drug Facts

Product Profile

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

norethindrone acetate 5 mg/1

Manufacturer
Amneal Pharmaceuticals LLC

Identifiers & Regulatory

Product NDC 65162-475
Product ID 65162-475_764f6075-288a-4435-b148-35589e5e5835
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA200275
Listing Expiration 2026-12-31
Marketing Start 2009-07-01

Pharmacologic Class

Classes
progesterone congeners [cs] progestin [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 65162475
Hyphenated Format 65162-475

Supplemental Identifiers

RxCUI
1000405
UPC
0365162475098
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 (source: ndc)
Application Number ANDA200275 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BOTTLE (65162-475-03)
  • 50 TABLET in 1 BOTTLE (65162-475-05)
  • 90 TABLET in 1 BOTTLE (65162-475-09)
  • 500 TABLET in 1 BOTTLE (65162-475-50)
source: ndc

Packages (4)

65162-475-03 30 TABLET in 1 BOTTLE (65162-475-03) 65162-475-05 50 TABLET in 1 BOTTLE (65162-475-05) 65162-475-09 90 TABLET in 1 BOTTLE (65162-475-09) 65162-475-50 500 TABLET in 1 BOTTLE (65162-475-50)

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": "764f6075-288a-4435-b148-35589e5e5835", "openfda": {"upc": ["0365162475098"], "unii": ["9S44LIC7OJ"], "rxcui": ["1000405"], "spl_set_id": ["64cb920c-36e8-4d62-9d08-3ddf3989d313"], "manufacturer_name": ["Amneal Pharmaceuticals LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE (65162-475-03)", "package_ndc": "65162-475-03", "marketing_start_date": "20090701"}, {"sample": false, "description": "50 TABLET in 1 BOTTLE (65162-475-05)", "package_ndc": "65162-475-05", "marketing_start_date": "20090701"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (65162-475-09)", "package_ndc": "65162-475-09", "marketing_start_date": "20090701"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (65162-475-50)", "package_ndc": "65162-475-50", "marketing_start_date": "20090701"}], "brand_name": "Norethindrone Acetate", "product_id": "65162-475_764f6075-288a-4435-b148-35589e5e5835", "dosage_form": "TABLET", "pharm_class": ["Progesterone Congeners [CS]", "Progestin [EPC]"], "product_ndc": "65162-475", "generic_name": "Norethindrone", "labeler_name": "Amneal Pharmaceuticals LLC", "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": "20090701", "listing_expiration_date": "20261231"}