Over-the-counter drug · ANDA
Levonorgestrel NDC 79929-016
Levonorgestrel 1.5 mg/1 · Tablet · Oral · Naari Pte Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 79929-016-01 | 79929001601 | 1 BLISTER PACK in 1 BOX, UNIT-DOSE (79929-016-01) / 1 TABLET in 1 BLISTER PACKMarketed from Feb 16, 2023 |
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)
- Levonorgestrel
- Generic name (nonproprietary)
- levonorgestrel
- Active ingredients
- Levonorgestrel — 1.5 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Naari Pte Limited
- 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 79929-016_ed724923-1eda-4b4f-b627-df51408be526SPL ID ed724923-1eda-4b4f-b627-df51408be526SPL set ID be8b7ace-9af8-4417-85fa-863e19072887RxCUI 483325UNII 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
N479929001601followed by a unit qualifier and the quantityPackage 79929-0016-01. 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 .
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.
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 |
| Restartlevonorgestrel | Levonorgestrel 1.5 mg/1 | TabletOral | Winx Health Inc. | 80584-103 |
| 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 |