lyleq

Generic: norethindrone

Labeler: afaxys pharma, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name lyleq
Generic Name norethindrone
Labeler afaxys pharma, llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

norethindrone .35 mg/1

Manufacturer
Afaxys Pharma, LLC

Identifiers & Regulatory

Product NDC 50102-300
Product ID 50102-300_ffb8f5fe-9e1a-4ca9-adc9-181093af01b9
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA207304
Listing Expiration 2026-12-31
Marketing Start 2016-09-23

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 50102300
Hyphenated Format 50102-300

Supplemental Identifiers

RxCUI
198042 748961 2397128
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 lyleq (source: ndc)
Generic Name norethindrone (source: ndc)
Application Number ANDA207304 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • .35 mg/1
source: ndc
Packaging
  • 3 PACKAGE in 1 CARTON (50102-300-13) / 1 BLISTER PACK in 1 PACKAGE (50102-300-11) / 28 TABLET in 1 BLISTER PACK (50102-300-01)
source: ndc

Packages (1)

50102-300-13 3 PACKAGE in 1 CARTON (50102-300-13) / 1 BLISTER PACK in 1 PACKAGE (50102-300-11) / 28 TABLET in 1 BLISTER PACK (50102-300-01)

Ingredients (1)

norethindrone (.35 mg/1)

Linked Drug Pages (1)

Lyleq ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "ffb8f5fe-9e1a-4ca9-adc9-181093af01b9", "openfda": {"nui": ["M0447349", "N0000175602"], "unii": ["T18F433X4S"], "rxcui": ["198042", "748961", "2397128"], "spl_set_id": ["c9f00a3e-c827-4066-bf85-079b3a20f25e"], "pharm_class_cs": ["Progesterone Congeners [CS]"], "pharm_class_epc": ["Progestin [EPC]"], "manufacturer_name": ["Afaxys Pharma, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "3 PACKAGE in 1 CARTON (50102-300-13)  / 1 BLISTER PACK in 1 PACKAGE (50102-300-11)  / 28 TABLET in 1 BLISTER PACK (50102-300-01)", "package_ndc": "50102-300-13", "marketing_start_date": "20160923"}], "brand_name": "Lyleq", "product_id": "50102-300_ffb8f5fe-9e1a-4ca9-adc9-181093af01b9", "dosage_form": "TABLET", "pharm_class": ["Progesterone Congeners [CS]", "Progestin [EPC]"], "product_ndc": "50102-300", "generic_name": "NORETHINDRONE", "labeler_name": "Afaxys Pharma, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Lyleq", "active_ingredients": [{"name": "NORETHINDRONE", "strength": ".35 mg/1"}], "application_number": "ANDA207304", "marketing_category": "ANDA", "marketing_start_date": "20160923", "listing_expiration_date": "20261231"}