norethindrone acetate

Generic: norethindrone acetate

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

Drug Facts

Product Profile

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

norethindrone acetate 5 mg/1

Manufacturer
Glenmark Pharmaceuticals Inc., USA

Identifiers & Regulatory

Product NDC 68462-304
Product ID 68462-304_61f08f82-c9ec-45cf-ab8b-18afabde75e2
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA091090
Listing Expiration 2027-12-31
Marketing Start 2010-07-21

Pharmacologic Class

Classes
progesterone congeners [cs] progestin [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68462304
Hyphenated Format 68462-304

Supplemental Identifiers

RxCUI
1000405
UPC
0368462304501
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 ANDA091090 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 500 TABLET in 1 BOTTLE (68462-304-05)
  • 50 TABLET in 1 BOTTLE (68462-304-50)
source: ndc

Packages (2)

68462-304-05 500 TABLET in 1 BOTTLE (68462-304-05) 68462-304-50 50 TABLET in 1 BOTTLE (68462-304-50)

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": "61f08f82-c9ec-45cf-ab8b-18afabde75e2", "openfda": {"upc": ["0368462304501"], "unii": ["9S44LIC7OJ"], "rxcui": ["1000405"], "spl_set_id": ["d0a94321-eb60-4aa6-a429-f0156f9f8e01"], "manufacturer_name": ["Glenmark Pharmaceuticals Inc., USA"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "500 TABLET in 1 BOTTLE (68462-304-05)", "package_ndc": "68462-304-05", "marketing_start_date": "20100721"}, {"sample": false, "description": "50 TABLET in 1 BOTTLE (68462-304-50)", "package_ndc": "68462-304-50", "marketing_start_date": "20100721"}], "brand_name": "Norethindrone Acetate", "product_id": "68462-304_61f08f82-c9ec-45cf-ab8b-18afabde75e2", "dosage_form": "TABLET", "pharm_class": ["Progesterone Congeners [CS]", "Progestin [EPC]"], "product_ndc": "68462-304", "generic_name": "Norethindrone Acetate", "labeler_name": "Glenmark Pharmaceuticals Inc., USA", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Norethindrone Acetate", "active_ingredients": [{"name": "NORETHINDRONE ACETATE", "strength": "5 mg/1"}], "application_number": "ANDA091090", "marketing_category": "ANDA", "marketing_start_date": "20100721", "listing_expiration_date": "20271231"}