norethindrone

Generic: norethindrone

Labeler: pd-rx pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name norethindrone
Generic Name norethindrone
Labeler pd-rx pharmaceuticals, inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

norethindrone .35 mg/1

Manufacturer
PD-Rx Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 72789-439
Product ID 72789-439_2e82440c-7f1b-f694-e063-6394a90a5646
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA200980
Marketing Start 2013-06-24
Marketing End 2026-05-31

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 72789439
Hyphenated Format 72789-439

Supplemental Identifiers

RxCUI
198042 748961
UPC
0372789439792
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 ANDA200980 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • .35 mg/1
source: ndc
Packaging
  • 1 BLISTER PACK in 1 POUCH (72789-439-79) / 28 TABLET in 1 BLISTER PACK
source: ndc

Packages (1)

Ingredients (1)

norethindrone (.35 mg/1)

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["ORAL"], "spl_id": "2e82440c-7f1b-f694-e063-6394a90a5646", "openfda": {"nui": ["M0447349", "N0000175602"], "upc": ["0372789439792"], "unii": ["T18F433X4S"], "rxcui": ["198042", "748961"], "spl_set_id": ["19e77ccf-1138-4efa-a7f3-8367cc1e69a6"], "pharm_class_cs": ["Progesterone Congeners [CS]"], "pharm_class_epc": ["Progestin [EPC]"], "manufacturer_name": ["PD-Rx Pharmaceuticals, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "1 BLISTER PACK in 1 POUCH (72789-439-79)  / 28 TABLET in 1 BLISTER PACK", "package_ndc": "72789-439-79", "marketing_end_date": "20260531", "marketing_start_date": "20241015"}], "brand_name": "Norethindrone", "product_id": "72789-439_2e82440c-7f1b-f694-e063-6394a90a5646", "dosage_form": "TABLET", "pharm_class": ["Progesterone Congeners [CS]", "Progestin [EPC]"], "product_ndc": "72789-439", "generic_name": "Norethindrone", "labeler_name": "PD-Rx Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Norethindrone", "active_ingredients": [{"name": "NORETHINDRONE", "strength": ".35 mg/1"}], "application_number": "ANDA200980", "marketing_category": "ANDA", "marketing_end_date": "20260531", "marketing_start_date": "20130624"}