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Restart Levonorgestrel 1.5 mg Tablet, 1 tablet — NDC 80584-103-01 (Billing 80584-0103-01)

by Winx Health Inc. · 1 BLISTER PACK in 1 CARTON / 1 TABLET in 1 BLISTER PACK

This is a package of 1 tablet of Restart Levonorgestrel 1.5 mg Tablet from Winx Health Inc., marketed since Dec 2025 and currently FDA-listed. It is this product's only package size.

NDC 80584-0103-01
🏷️ FDA NDC (as labeled) 80584-103-01 billing pads the product segment with a zero
OTC Generic On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 80584-103-01
Product NDC 80584-103
11-digit billing NDC 80584010301
RxCUI 483325, 2722270
UNII 5W7SIA7YZW
Application # ANDA207660
SPL Set ID 0cdf198e-c114-b9fa-e063-6294a90a566a
Established class (EPC) Progestin; Progestin-containing Intrauterine System
Physiologic effect Inhibit Ovum Fertilization
Chemical class Progesterone Congeners
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2025-12-19
Route ORAL
Dosage form TABLET
Substance LEVONORGESTREL
Quick answers
  • RxCUI (RxNorm): 483325
Why two NDCs? The FDA registers this code as 80584-103-01 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 80584-0103-01. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

RxNorm drug class

This medicine belongs to the Progestin class.

Pharmacologic class Progestin, Progestin-containing Intrauterine System
Drug family (ATC) Progestogens and estrogens, sequential preparations, Progestogens, Emergency contraceptives
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

Clinical

📗 Our plain-language guide HelloPharmacist
  • It comes in two main types. The intrauterine systems (Mirena, Liletta, Kyleena, Skyla) prevent pregnancy for years, and Mirena and Liletta also treat heavy menstrual bleeding. The...
  • Take it as soon as you can, within 72 hours (3 days) of unprotected sex. The sooner you take it, the better it works. If you vomit within 2 hours, call a healthcare professional to...
  • How do I take the emergency contraceptive tablet?
  • No. It's a backup method and isn't as effective as regular birth control. It also won't work if you're already pregnant, and it doesn't protect against HIV or other STDs.
📖 Read our full Levonorgestrel guide →
2
Nutrient depletion considerations

Levonorgestrel may be associated with lower levels of 2 nutrients — worth a chat with your pharmacist, not a cause for alarm.

🧪 Full Levonorgestrel nutrient depletion report →
An association is not a deficiency. Educational only — don't start or stop anything without professional guidance.
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer eachPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
80584-0103-01 You're viewing this Main listing 1 BLISTER PACK in 1 CARTON / 1 TABLET in 1 BLISTER PACK 2025-12-19 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Option 2 1.5 mg 00113-2003-12 L. 1 tablet $6.331 — Availability likely —
Levonorgestrel 1.5 mg 00536-1433-63 Rugby 1 tablet $6.331 — Availability likely —
New Day 1.5 mg 16714-0809-01 Northstar 1 tablet $6.331 — Availability likely —
EContra One-Step 1.5 mg 50102-0211-13 Afaxys 3 tablets $6.331 — Availability likely —
My Choice TM 1.5 mg 62756-0720-60 SUN 1 tablet $6.331 — Availability likely —
My Way 1.5 mg 68180-0852-11 Lupin 1 tablet $6.331 — Availability likely —
Levonorgestrel 1.5 mg 70700-0164-06 Xiromed 1 tablet $6.331 — Availability likely —
Her Style 1.5 mg 50742-0352-01 Ingenus 1 tablet $6.797 — FDA listed —
Opcicon One-Step 1.5 mg 62756-0718-60 Sun 1 tablet $6.797 — FDA listed —
Levonorgestrel 1.5 mg 40032-0622-30 Novel 1 tablet — — FDA listed —
My Way 1.5 mg 43386-0622-30 Lupin 1 tablet — — FDA listed —
Plan B One-Step 1.5 mg 50090-5978-00 A-S 1 tablet — — FDA listed —
My Choice 1.5 mg 51660-0096-11 OHM 1 tablet — — FDA listed —
Levonorgestrel 1.5 mg 51660-0723-11 Ohm 1 tablet — — FDA listed —
Levonorgestrel 1.5 mg 51660-0999-11 Ohm 1 tablet — — FDA listed —
Fem Choice morning after 1.5 mg 58602-0712-28 Aurohealth 1 tablet — — FDA listed —
Athentia Next 1.5 mg 58602-0721-57 Aurohealth 1 tablet — — FDA listed —
Econ Morning After 1.5 mg 58602-0841-48 Aurohealth 3 tablets — — FDA listed —
After Banger 1.5 mg 58602-0891-57 Aurohealth 1 tablet — — FDA listed —
Ithappenz Morning After 1.5 mg 58602-0892-57 Aurohealth 1 tablet — — FDA listed —
Levonorgestrel Tablet, 1.5 mg 59556-0282-01 Strides 1 tablet — — FDA listed —
Optionelle 1.5 mg 59556-0286-01 Strides 1 tablet — — FDA listed —
Emergency Contraceptive 1.5 mg 59726-0138-01 P 1 tablet — — FDA listed —
AfterPlan 1.5 mg 62756-0723-60 SUN 1 tablet — — FDA listed —
AfterPill 1.5 mg 64122-0605-01 Syzygy 1 tablet — — FDA listed —
My Way 1.5 mg 68071-4294-01 NuCare 1 tablet — — FDA listed —
Levonorgestrel 1.5 mg 69230-0333-32 Camber 1 tablet — — FDA listed —
Aftera 1.5 mg 69536-0103-88 Foundation 1 tablet — — FDA listed —
Next Choice One Dose 1.5 mg 69536-0133-88 Foundation 1 tablet — — FDA listed —
Plan B One-Step 1.5 mg 69536-0146-19 Foundation 1 tablet — — FDA listed —
Plan B One-Step 1.5 mg 69536-0162-88 Foundation 1 tablet — — FDA listed —
Take Action 1.5 mg 69536-0200-88 Foundation 1 tablet — — FDA listed —
Morning After 1.5 mg/1.5mg 69953-0515-01 Rapha 1 mg — — FDA listed —
Morning After 1.5 mg/1.5mg 69953-0516-01 Rapha 1 mg — — FDA listed —
Morning After 1.5 mg/1.5mg 69953-0517-01 Rapha 1 mg — — FDA listed —
PostDay One-Step 1.5 mg/1.5mg 69953-0617-42 Rapha 1 mg — — FDA listed —
PostDay One-Step 1.5 mg/1.5mg 69953-0618-43 Rapha 1 mg — — FDA listed —
PostDay One-Step 1.5 mg/1.5mg 69953-0628-60 Rapha 1 mg — — FDA listed —
LEADER Emergency Contraceptive Levonorgestrel 1.5 mg 70000-0600-01 Cardinal 1 tablet — — FDA listed —
Levonorgestrel 1.5 mg 70000-0675-01 LEADER/ 1 tablet — — FDA listed —
My Choice TM 1.5 mg 71205-0120-01 Proficient 1 tablet — — FDA listed —
My Way 1.5 mg 71205-0361-01 Proficient 1 tablet — — FDA listed —
Levonorgestrel 1.5 mg 71713-0098-11 Thirty 1 tablet — — FDA listed —
Amazon Basic Care Levonorgestrel 1.5 mg 72288-0324-28 Amazon.com 1 tablet — — FDA listed —
SheWise 1.5 mg 72657-0108-11 GLENMARK 1 tablet — — Discontinued —
Levonorgestrel 1.5 mg 72657-0123-11 GLENMARK 1 tablet — — FDA listed —
Morning After Pill 1.5 mg 73436-2859-01 Cadence 1 tablet — — FDA listed —
Morning After Pill 1.5 mg 73436-8292-01 Cadence 1 tablet — — FDA listed —
Levonorgestrel 1.5 mg 73581-0217-01 YYBA 1 tablet — — FDA listed —
Levonorgestrel 1.5 mg 79929-0016-01 Naari 1 tablet — — FDA listed —
Restart 1.5 mgthis 80584-0103-01 Winx 1 tablet — — FDA listed —
Julie Morning After Pill 1.5 mg 82791-0002-01 Julie 1 tablet — — FDA listed —
Julie Morning After Pill 1.5 mg 82791-0003-01 Julie 1 tablet — — FDA listed —
Julie 1.5 mg 82791-0335-01 Julie 1 tablet — — FDA listed —
Julie 1.5 mg 82791-0532-01 Julie 1 tablet — — FDA listed —
Julie 1.5 mg 82791-0538-01 Julie 1 tablet — — FDA listed —
PostDay One-Step 1.5 mg 85506-0100-10 Home 1 tablet — — FDA listed —
Option 2 1.5 mg 00113-8099-12 L. 1 tablet — — FDA listed —
Levonorgestrel 1.5 mg 73581-0017-01 YYBA 1 tablet — — FDA listed —
Julie Morning After Pill 1.5 mg 82791-0004-01 Julie 1 tablet — — FDA listed —
My After Plan 1.5 mg 51660-0098-11 OHM 1 tablet — — FDA listed —
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
2025
On the market since
Dec 2025
📍
2026
Currently FDA-listed
1 year listed
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII EWQ57Q8I5X
    Lactose monohydrate is a natural sugar derived from milk. It serves as a filler and binder in tablets and capsules, helping create the proper size, texture, and consistency of the medicine.
  • UNII 70097M6I30
    Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
  • UNII ETJ7Z6XBU4
    Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.
  • UNII O8232NY3SJ
    A plant-based carbohydrate derived from corn kernels. It acts as a filler to add bulk, a binder to hold ingredients together, and a disintegrant to help the tablet break apart in your stomach for absorption.
  • UNII 8I089SAH3T
    A carbohydrate powder extracted from potatoes. It serves as a filler to add bulk and volume to the tablet or capsule, and as a disintegrant to help the medicine break apart and release its active ingredient in your body.
  • UNII 7SEV7J4R1U
    A powder made from a naturally occurring mineral. In medicines, talc works as a glidant and anti-caking agent, helping tablets and capsules flow smoothly during manufacturing and preventing clumping.

6 inactive ingredients listed in the exact product block matched to this NDC.

The official label also statesLactose Monohydrate, Corn Starch, Potato Starch, Colloidal Silicon Dioxide, Talc and Magnesium Stearate.

Label-section wording can be broader than the structured product block and may mention additional formulation ingredients.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

Manufacturer & labeler

LabelerWinx Health Inc.
Application holderNAARI PTE LTD
FDA applicationANDA207660 (ANDA)
Labeler code80584
First marketedDec 2025
Product typeHuman Otc Drug
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

FDA label — Drug Facts FDA SPL

The complete FDA label for this product — the official Drug Facts labeling, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration ⚠️ Warnings 📦 Storage and Handling 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose
🎯 Indications and Usage 23 words ▾

Use for women to reduce chance of pregnancy after unprotected sex (if a contraceptive failed or if you did not use birth control)

⏱️ Dosage and Administration 47 words ▾

Directions take as soon as possible within 72 hours (3 days) after unprotected sex. The sooner you take it, the better it will work. if you vomit within 2 hours of taking the medication, call a healthcare professional to find out if you should repeat that dose.

⚠️ Warnings 32 words ▾

Warnings Allergy Alert : Do not use if you have ever had an allergic reaction to levonorgestrel Sexually transmitted diseases (STDs) Alert: This product does not protect against HIV/AIDS or other STDs

📦 Storage and Handling 41 words ▾

Other information read the instructions, warnings, and enclosed product leaflet before use do not use if the carton is open, if tear strip is removed or if blister seal is broken or missing store at 20° to 25°C (68° to 77°F)

🧪 Active Ingredient 5 words ▾

Active ingredient Levonorgestrel 1.5 mg

🧪 Inactive Ingredients 15 words ▾

Inactive ingredients Lactose Monohydrate, Corn Starch, Potato Starch, Colloidal Silicon Dioxide, Talc and Magnesium Stearate.

🎯 Purpose 3 words ▾

Purpose Emergency contraceptive

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Mirena (matched by generic name) — the program that covers self-administered drugs. 1 manufacturer.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Mirena. CMS lists 4 products for this generic; we show the highest-spend one. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$198.1K
Claims incl. refills
161
Beneficiaries
160
Spend / beneficiary
$1,238.34
Spend / claim
$1,230.65
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Levonorgestrel — the ingredient across all brands.

Top reported reactions

Device Expulsion45,539
Device Dislocation20,446
Menstruation Irregular15,060
Vaginal Haemorrhage15,056
Genital Haemorrhage11,162
Abdominal Pain Lower9,315
Nausea8,806

Age at onset

Neonate87
Infant54
Child25
Adolescent1,518
Adult62,663
Elderly189

Reporter sex

206,324 reports
Male · 1%
Female · 99%
Unknown · 0%

Serious outcomes

Hospitalization11,401
Disabling2,216
Life-threatening2,084
Reports over time (by year) — tap or hover for the count & year
2021 2022 2024 2026 8,857 3,283
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

About this NDC listing & data coverage

Over-the-counter (OTC) product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos — Not published for this NDC No photo available yet for this listing.
Inactive ingredients (structured) ✓ Available
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope.
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Winx Health Inc.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Winx Health Inc. is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as an over-the-counter product, so it does not require a prescription. Follow the package directions, and ask your pharmacist if you are unsure whether it is right for you.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.
← 80579-0001-01 · Walla 80584-0113-24 · Get →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.