What is NDC 80584-103?

80584-103 is the product NDC for Restart (levonorgestrel), Levonorgestrel 1.5 mg/1 tablet, listed with the FDA by Winx Health Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.

Winx Health Inc., NDC labeler code 80584. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Restart?

None: this is the only finished product listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Restart NDC 80584-103 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)80584-103Labeler and product segments. Claims need a package NDC.

Product NDC at billing width80584-0103Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package	Copy
80584-103-01	8058401030180584010301	1 BLISTER PACK in 1 CARTON (80584-103-01) / 1 TABLET in 1 BLISTER PACKMarketed from Dec 19, 2025

How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules

Product information

Brand name (proprietary): Restart
Generic name (nonproprietary): levonorgestrel
Active ingredients: Levonorgestrel — 1.5 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Winx Health Inc.NDC labeler code 80584
Product type: Over-the-counter drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 207660
Marketing start: Dec 19, 2025
Listing expires: Dec 31, 2027
Other FDA classes: Inhibit Ovum Fertilization (Physiologic effect)Progesterone Congeners (Chemical structure)Progesterone Congeners (Chemical structure)
Identifiers: Product ID 80584-103_4b9d2263-945a-ebca-e063-6394a90a1bebSPL ID 4b9d2263-945a-ebca-e063-6394a90a1bebSPL set ID 0cdf198e-c114-b9fa-e063-6294a90a566aRxCUI 483325, 2722270UNII 5W7SIA7YZW
Pharmacologic class: Progestin; Progestin-containing Intrauterine System

Billing references

What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.

HCPCS codeNo match

No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N480584010301 followed by a unit qualifier and the quantity

Package 80584-0103-01. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier

Product label

Current FDA label (SPL), effective Feb 24, 2026.

Indications (excerpt from the label)

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

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 80584-103

What is NDC 80584-103?: 80584-103 is the product NDC for Restart (levonorgestrel), Levonorgestrel 1.5 mg/1 tablet, listed with the FDA by Winx Health Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Restart (Levonorgestrel).
What is the active ingredient?: Levonorgestrel.
Who is the labeler?: Winx Health Inc., NDC labeler code 80584. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Restart?: None: this is the only finished product listed under this name.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Other NDCs under ANDA 207660

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 207660
Product	Strength	Form · route	Labeler	Product NDC
Julielevonorgestrel	Levonorgestrel 1.5 mg/1	TabletOral	Julie Products Inc	82791-335
Levonorgestrel	Levonorgestrel 1.5 mg/1	TabletOral	Naari Pte Limited	79929-016
Morning After Pilllevonorgestrel	Levonorgestrel 1.5 mg/1	TabletOral	Cadence Health Inc	73436-8292
My After Planlevonorgestrel	Levonorgestrel 1.5 mg/1	TabletOral	OHM LABORATORIES INC	51660-098
My Choicelevonorgestrel	Levonorgestrel 1.5 mg/1	TabletOral	OHM LABORATORIES INC	51660-096

Restart (Levonorgestrel) NDC 80584-103