Prescription drug · ANDA
Letrozole (letrozole tablets) NDC 23155-875
Letrozole 2.5 mg/1 · Tablet, Film coated · Oral · Avet Pharmaceuticals Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 23155-875-03 | 23155087503 | 30 TABLET, FILM COATED in 1 BOTTLE (23155-875-03)Marketed from Jun 1, 2023 · Sample package | |
| 23155-875-09 | 23155087509 | 90 TABLET, FILM COATED in 1 BOTTLE (23155-875-09)Marketed from Jun 1, 2023 · Sample package | |
| 23155-875-10 | 23155087510 | 1000 TABLET, FILM COATED in 1 BOTTLE (23155-875-10)Marketed from Jun 1, 2023 · Sample package |
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)
- Letrozole
- Generic name (nonproprietary)
- letrozole tablets
- Active ingredients
- Letrozole — 2.5 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Avet Pharmaceuticals Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 205869
- Marketing start
- Listing expires
- Other FDA classes
- Aromatase Inhibitors (Mechanism)
- Identifiers
- Product ID 23155-875_40009527-770b-8999-e063-6294a90a9946SPL ID 40009527-770b-8999-e063-6294a90a9946SPL set ID fe0e4d4b-436d-a36d-e053-6294a90a973dRxCUI 200064UNII 7LKK855W8IUPC 0323155875096, 0323155875102, 0323155875034
- Pharmacologic class
- Aromatase Inhibitor
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
N423155087503followed by a unit qualifier and the quantityPackage 23155-0875-03. 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)
Letrozole Tablets are aromatase inhibitor indicated for: Adjuvant treatment of postmenopausal women with hormone receptor positive early breast cancer ( 1.1 ) Extended adjuvant treatment of postmenopausal women with early breast cancer who have received prior standard adjuvant tamoxifen therapy ( 1.2 ) First and second-line treatment of postmenopausal women with hormone receptor positive or unknown advanced breast cancer ( 1.3 ) 1.1 Adjuvant Treatment of Early Breast Cancer Letrozole tablets, are indicated for the adjuvant treatment of postmenopausal women with hormone receptor positive early breast cancer. 1.2 Extended Adjuvant Treatment of Early Breast Cancer Letrozole tablets, are indicat…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 205869
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 |
|---|---|---|---|---|
| Letrozole | Letrozole 2.5 mg/1 | Tablet, Film coatedOral | Chartwell RX, LLC | 62135-491 |
| Letrozoleletrozole tablets | Letrozole 2.5 mg/1 | Tablet, Film coatedOral | Golden State Medical Supply, Inc. | 51407-986 |
| Letrozoleletrozole tablets | Letrozole 2.5 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-2396 |
| Letrozoleletrozole tablets | Letrozole 2.5 mg/1 | Tablet, Film coatedOral | Upsher-Smith Laboratories, LLC | 24979-726 |
| Letrozoleletrozole tablets | Letrozole 2.5 mg/1 | Tablet, Film coatedOral | Yiling Pharmaceutical, Inc. | 69117-0004 |