Restart
- Product NDC
- 80584-103
- 11-digit product format
- 805840103
- Labeler code
- 80584
- Product ID
- 80584-103_3d594e56-b2b5-8a28-e063-6394a90a20e1
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Levonorgestrel
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Winx Health Inc.
- Application
- ANDA207660
- Marketing category
- ANDA
- Marketing start
- 2024-10-08
- Substance
- LEVONORGESTREL
- Active strength
- 1.5 mg/1
- Pharmacologic classes
- Inhibit Ovum Fertilization [PE], Progesterone Congeners [CS], Progesterone Congeners [CS], Progestin [EPC], Progestin-containing Intrauterine System [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Restart
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| LEVONORGESTREL | 1.5 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 5W7SIA7YZW |
| Rxcui | 483325, 2722270 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 80584-103-01 | Restart | 1 in 1 BLISTER PACK | TABLET | 1 | | 6 |
| 80584-103-01 | Restart | 1 in 1 CARTON | TABLET | 1 | | 6 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 80584-103-01 | 80584010301 | 1 BLISTER PACK in 1 CARTON (80584-103-01) / 1 TABLET in 1 BLISTER PACK | 1 blister pack | 2024-10-08 | No | No | Current |