restart

Generic: levonorgestrel

Labeler: winx health inc.
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name restart
Generic Name levonorgestrel
Labeler winx health inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

levonorgestrel 1.5 mg/1

Manufacturer
Winx Health Inc.

Identifiers & Regulatory

Product NDC 80584-103
Product ID 80584-103_3d594e56-b2b5-8a28-e063-6394a90a20e1
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA207660
Listing Expiration 2026-12-31
Marketing Start 2024-10-08

Pharmacologic Class

Established (EPC)
progestin [epc] progestin-containing intrauterine system [epc]
Chemical Structure
progesterone congeners [cs]
Physiologic Effect
inhibit ovum fertilization [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 80584103
Hyphenated Format 80584-103

Supplemental Identifiers

RxCUI
483325 2722270
UNII
5W7SIA7YZW
NUI
N0000175830 M0447349 N0000175602 N0000175832

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 restart (source: ndc)
Generic Name levonorgestrel (source: ndc)
Application Number ANDA207660 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 1.5 mg/1
source: ndc
Packaging
  • 1 BLISTER PACK in 1 CARTON (80584-103-01) / 1 TABLET in 1 BLISTER PACK
source: ndc

Packages (1)

80584-103-01 1 BLISTER PACK in 1 CARTON (80584-103-01) / 1 TABLET in 1 BLISTER PACK

Ingredients (1)

levonorgestrel (1.5 mg/1)

Linked Drug Pages (1)

Restart ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "3d594e56-b2b5-8a28-e063-6394a90a20e1", "openfda": {"nui": ["N0000175830", "M0447349", "N0000175602", "N0000175832"], "unii": ["5W7SIA7YZW"], "rxcui": ["483325", "2722270"], "spl_set_id": ["0cdf198e-c114-b9fa-e063-6294a90a566a"], "pharm_class_cs": ["Progesterone Congeners [CS]"], "pharm_class_pe": ["Inhibit Ovum Fertilization [PE]"], "pharm_class_epc": ["Progestin [EPC]", "Progestin-containing Intrauterine System [EPC]"], "manufacturer_name": ["Winx Health Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BLISTER PACK in 1 CARTON (80584-103-01)  / 1 TABLET in 1 BLISTER PACK", "package_ndc": "80584-103-01", "marketing_start_date": "20241008"}], "brand_name": "Restart", "product_id": "80584-103_3d594e56-b2b5-8a28-e063-6394a90a20e1", "dosage_form": "TABLET", "pharm_class": ["Inhibit Ovum Fertilization [PE]", "Progesterone Congeners [CS]", "Progesterone Congeners [CS]", "Progestin [EPC]", "Progestin-containing Intrauterine System [EPC]"], "product_ndc": "80584-103", "generic_name": "Levonorgestrel", "labeler_name": "Winx Health Inc.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Restart", "active_ingredients": [{"name": "LEVONORGESTREL", "strength": "1.5 mg/1"}], "application_number": "ANDA207660", "marketing_category": "ANDA", "marketing_start_date": "20241008", "listing_expiration_date": "20261231"}