norethindrone

Generic: norethindrone

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

Drug Facts

Product Profile

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

norethindrone .35 mg/1

Manufacturer
Lupin Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 68180-876
Product ID 68180-876_21d08d75-2957-4610-94c1-76c844ba2f1b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA091325
Listing Expiration 2026-12-31
Marketing Start 2020-11-11

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68180876
Hyphenated Format 68180-876

Supplemental Identifiers

RxCUI
198042 748961
UPC
0368180876717
UNII
T18F433X4S
NUI
M0447349 N0000175602

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 (source: ndc)
Generic Name norethindrone (source: ndc)
Application Number ANDA091325 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • .35 mg/1
source: ndc
Packaging
  • 3 BLISTER PACK in 1 CARTON (68180-876-73) / 28 TABLET in 1 BLISTER PACK
source: ndc

Packages (1)

68180-876-73 3 BLISTER PACK in 1 CARTON (68180-876-73) / 28 TABLET in 1 BLISTER PACK

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": "21d08d75-2957-4610-94c1-76c844ba2f1b", "openfda": {"nui": ["M0447349", "N0000175602"], "upc": ["0368180876717"], "unii": ["T18F433X4S"], "rxcui": ["198042", "748961"], "spl_set_id": ["121fbf86-1d76-4579-be2f-be9a957b23ab"], "pharm_class_cs": ["Progesterone Congeners [CS]"], "pharm_class_epc": ["Progestin [EPC]"], "manufacturer_name": ["Lupin Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "3 BLISTER PACK in 1 CARTON (68180-876-73)  / 28 TABLET in 1 BLISTER PACK", "package_ndc": "68180-876-73", "marketing_start_date": "20201111"}], "brand_name": "NORETHINDRONE", "product_id": "68180-876_21d08d75-2957-4610-94c1-76c844ba2f1b", "dosage_form": "TABLET", "pharm_class": ["Progesterone Congeners [CS]", "Progestin [EPC]"], "product_ndc": "68180-876", "generic_name": "NORETHINDRONE", "labeler_name": "Lupin Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "NORETHINDRONE", "active_ingredients": [{"name": "NORETHINDRONE", "strength": ".35 mg/1"}], "application_number": "ANDA091325", "marketing_category": "ANDA", "marketing_start_date": "20201111", "listing_expiration_date": "20261231"}