Over-the-counter drug · ANDA
SheWise (levonorgestrel) NDC 72657-108
Levonorgestrel 1.5 mg/1 · Tablet · Oral · GLENMARK THERAPEUTICS INC., USA
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 72657-108-12 | 72657010812 | 1 BLISTER PACK in 1 CARTON (72657-108-12) / 1 TABLET in 1 BLISTER PACKMarketed from Jul 29, 2022 |
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)
- SheWise
- Generic name (nonproprietary)
- levonorgestrel
- Active ingredients
- Levonorgestrel — 1.5 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 207044
- Marketing start
- Listing expires
- Other FDA classes
- Inhibit Ovum Fertilization (Physiologic effect)Progesterone Congeners (Chemical structure)Progesterone Congeners (Chemical structure)
- Identifiers
- Product ID 72657-108_6762d7cd-be6a-412c-961c-0864b2483cebSPL ID 6762d7cd-be6a-412c-961c-0864b2483cebSPL set ID 7be13a7e-b4ff-4fe1-82a6-f9914596d72aRxCUI 483325, 2730936UNII 5W7SIA7YZWUPC 0372657108126
- 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
N472657010812followed by a unit qualifier and the quantityPackage 72657-0108-12. 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)
Indications 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 207044
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 |
|---|---|---|---|---|
| Levonorgestrel | Levonorgestrel 1.5 mg/1 | TabletOral | YYBA Corp | 73581-217 |
| PostDay One-Steplevonorgestrel | Levonorgestrel 1.5 mg/1 | TabletOral | Home Health Brands, LLC | 85506-100 |
| Levonorgestrel | Levonorgestrel 1.5 mg/1 | TabletOral | GLENMARK THERAPEUTICS INC., USA | 72657-123 |