norethindrone

Generic: norethindrone

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

Drug Facts

Product Profile

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

norethindrone .35 mg/1

Manufacturer
Mylan Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 0378-7292
Product ID 0378-7292_952f8023-4a5f-746d-c678-388b50e8909c
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA201483
Listing Expiration 2026-12-31
Marketing Start 2013-07-12

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 03787292
Hyphenated Format 0378-7292

Supplemental Identifiers

RxCUI
198042 748961
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 ANDA201483 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • .35 mg/1
source: ndc
Packaging
  • 3 POUCH in 1 CARTON (0378-7292-53) / 1 BLISTER PACK in 1 POUCH (0378-7292-85) / 28 TABLET in 1 BLISTER PACK
source: ndc

Packages (1)

0378-7292-53 3 POUCH in 1 CARTON (0378-7292-53) / 1 BLISTER PACK in 1 POUCH (0378-7292-85) / 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": "952f8023-4a5f-746d-c678-388b50e8909c", "openfda": {"nui": ["M0447349", "N0000175602"], "unii": ["T18F433X4S"], "rxcui": ["198042", "748961"], "spl_set_id": ["af851d82-b30f-463b-9dba-0437225dc1ee"], "pharm_class_cs": ["Progesterone Congeners [CS]"], "pharm_class_epc": ["Progestin [EPC]"], "manufacturer_name": ["Mylan Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "3 POUCH in 1 CARTON (0378-7292-53)  / 1 BLISTER PACK in 1 POUCH (0378-7292-85)  / 28 TABLET in 1 BLISTER PACK", "package_ndc": "0378-7292-53", "marketing_start_date": "20130712"}], "brand_name": "NORETHINDRONE", "product_id": "0378-7292_952f8023-4a5f-746d-c678-388b50e8909c", "dosage_form": "TABLET", "pharm_class": ["Progesterone Congeners [CS]", "Progestin [EPC]"], "product_ndc": "0378-7292", "generic_name": "norethindrone", "labeler_name": "Mylan Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "NORETHINDRONE", "active_ingredients": [{"name": "NORETHINDRONE", "strength": ".35 mg/1"}], "application_number": "ANDA201483", "marketing_category": "ANDA", "marketing_start_date": "20130712", "listing_expiration_date": "20261231"}