Over-the-counter drug · ANDA
Restart (levonorgestrel) NDC 80584-103
Levonorgestrel 1.5 mg/1 · Tablet · Oral · Winx Health Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 80584-103-01 | 80584010301 | 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.
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 207660
- Marketing start
- Listing expires
- 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
N480584010301followed by a unit qualifier and the quantityPackage 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
Label details couldn’t be retrieved right now. Open the label on DailyMed.
Other NDCs under ANDA 207660
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Morning After Pilllevonorgestrel | Levonorgestrel 1.5 mg/1 | TabletOral | Cadence Health Inc | 73436-8292 |
| My Choicelevonorgestrel | Levonorgestrel 1.5 mg/1 | TabletOral | OHM LABORATORIES INC | 51660-096 |
| My After Planlevonorgestrel | Levonorgestrel 1.5 mg/1 | TabletOral | OHM LABORATORIES INC | 51660-098 |
| Julielevonorgestrel | Levonorgestrel 1.5 mg/1 | TabletOral | Julie Products Inc | 82791-335 |
| Levonorgestrel | Levonorgestrel 1.5 mg/1 | TabletOral | Naari Pte Limited | 79929-016 |