norethindrone

Generic: norethindrone

Labeler: proficient rx lp
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name norethindrone
Generic Name norethindrone
Labeler proficient rx lp
Dosage Form TABLET
Routes
ORAL
Active Ingredients

norethindrone .35 mg/1

Manufacturer
Proficient Rx LP

Identifiers & Regulatory

Product NDC 63187-748
Product ID 63187-748_a55952ea-18c3-4e7b-bb29-16518eae5ff2
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA091209
Listing Expiration 2026-12-31
Marketing Start 2010-11-03

Pharmacologic Class

Established (EPC)
progestin [epc]
Chemical Structure
progesterone congeners [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 63187748
Hyphenated Format 63187-748

Supplemental Identifiers

RxCUI
198042 748961
UNII
T18F433X4S
NUI
M0447349 N0000175602

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 (source: ndc)
Generic Name norethindrone (source: ndc)
Application Number ANDA091209 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • .35 mg/1
source: ndc
Packaging
  • 28 TABLET in 1 POUCH (63187-748-28)
source: ndc

Packages (1)

63187-748-28 28 TABLET in 1 POUCH (63187-748-28)

Ingredients (1)

norethindrone (.35 mg/1)

Linked Drug Pages (1)

Norethindrone ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "a55952ea-18c3-4e7b-bb29-16518eae5ff2", "openfda": {"nui": ["M0447349", "N0000175602"], "unii": ["T18F433X4S"], "rxcui": ["198042", "748961"], "spl_set_id": ["fb84b86e-5f1f-4c17-8b69-ff695c5faf55"], "pharm_class_cs": ["Progesterone Congeners [CS]"], "pharm_class_epc": ["Progestin [EPC]"], "manufacturer_name": ["Proficient Rx LP"]}, "finished": true, "packaging": [{"sample": false, "description": "28 TABLET in 1 POUCH (63187-748-28)", "package_ndc": "63187-748-28", "marketing_start_date": "20161003"}], "brand_name": "Norethindrone", "product_id": "63187-748_a55952ea-18c3-4e7b-bb29-16518eae5ff2", "dosage_form": "TABLET", "pharm_class": ["Progesterone Congeners [CS]", "Progestin [EPC]"], "product_ndc": "63187-748", "generic_name": "Norethindrone", "labeler_name": "Proficient Rx LP", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Norethindrone", "active_ingredients": [{"name": "NORETHINDRONE", "strength": ".35 mg/1"}], "application_number": "ANDA091209", "marketing_category": "ANDA", "marketing_start_date": "20101103", "listing_expiration_date": "20261231"}