heather

Generic: norethindrone

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

Drug Facts

Product Profile

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

norethindrone .35 mg/1

Manufacturer
Glenmark Pharmaceuticals Inc., USA

Identifiers & Regulatory

Product NDC 68462-303
Product ID 68462-303_9240d076-c4e6-4897-af0b-a2c403a6f06d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA090454
Listing Expiration 2027-12-31
Marketing Start 2010-04-23

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68462303
Hyphenated Format 68462-303

Supplemental Identifiers

RxCUI
198042 748961 977836
UPC
0368462303290
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 heather (source: ndc)
Generic Name norethindrone (source: ndc)
Application Number ANDA090454 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • .35 mg/1
source: ndc
Packaging
  • 3 BLISTER PACK in 1 CARTON (68462-303-29) / 28 TABLET in 1 BLISTER PACK (68462-303-84)
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": "9240d076-c4e6-4897-af0b-a2c403a6f06d", "openfda": {"nui": ["M0447349", "N0000175602"], "upc": ["0368462303290"], "unii": ["T18F433X4S"], "rxcui": ["198042", "748961", "977836"], "spl_set_id": ["35b5ddb5-1729-4588-b2a2-ead56d78b6f9"], "pharm_class_cs": ["Progesterone Congeners [CS]"], "pharm_class_epc": ["Progestin [EPC]"], "manufacturer_name": ["Glenmark Pharmaceuticals Inc., USA"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": true, "description": "3 BLISTER PACK in 1 CARTON (68462-303-29)  / 28 TABLET in 1 BLISTER PACK (68462-303-84)", "package_ndc": "68462-303-29", "marketing_start_date": "20100423"}], "brand_name": "HEATHER", "product_id": "68462-303_9240d076-c4e6-4897-af0b-a2c403a6f06d", "dosage_form": "TABLET", "pharm_class": ["Progesterone Congeners [CS]", "Progestin [EPC]"], "product_ndc": "68462-303", "generic_name": "Norethindrone", "labeler_name": "Glenmark Pharmaceuticals Inc., USA", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "HEATHER", "active_ingredients": [{"name": "NORETHINDRONE", "strength": ".35 mg/1"}], "application_number": "ANDA090454", "marketing_category": "ANDA", "marketing_start_date": "20100423", "listing_expiration_date": "20271231"}