norethindrone acetate

Generic: norethindrone acetate

Labeler: teva pharmaceuticals usa, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name norethindrone acetate
Generic Name norethindrone acetate
Labeler teva pharmaceuticals usa, inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

norethindrone acetate 5 mg/1

Manufacturer
Teva Pharmaceuticals USA, Inc.

Identifiers & Regulatory

Product NDC 0555-0211
Product ID 0555-0211_953441f0-0a24-40ba-a433-1de55da3ebaa
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA075951
Listing Expiration 2026-12-31
Marketing Start 2001-06-29

Pharmacologic Class

Classes
progesterone congeners [cs] progestin [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 05550211
Hyphenated Format 0555-0211

Supplemental Identifiers

RxCUI
1000405
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 ANDA075951 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 50 TABLET in 1 BOTTLE (0555-0211-10)
source: ndc

Packages (1)

0555-0211-10 50 TABLET in 1 BOTTLE (0555-0211-10)

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": "953441f0-0a24-40ba-a433-1de55da3ebaa", "openfda": {"unii": ["9S44LIC7OJ"], "rxcui": ["1000405"], "spl_set_id": ["f73f9807-4af6-4faa-ba9a-656a47a4c5e0"], "manufacturer_name": ["Teva Pharmaceuticals USA, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "50 TABLET in 1 BOTTLE (0555-0211-10)", "package_ndc": "0555-0211-10", "marketing_start_date": "20010629"}], "brand_name": "Norethindrone Acetate", "product_id": "0555-0211_953441f0-0a24-40ba-a433-1de55da3ebaa", "dosage_form": "TABLET", "pharm_class": ["Progesterone Congeners [CS]", "Progestin [EPC]"], "product_ndc": "0555-0211", "generic_name": "Norethindrone Acetate", "labeler_name": "Teva Pharmaceuticals USA, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Norethindrone Acetate", "active_ingredients": [{"name": "NORETHINDRONE ACETATE", "strength": "5 mg/1"}], "application_number": "ANDA075951", "marketing_category": "ANDA", "marketing_start_date": "20010629", "listing_expiration_date": "20261231"}