Prescription drug · ANDA
Letrozole NDC 51991-759
Letrozole 2.5 mg/1 · Tablet · Oral · Breckenridge Pharmaceutical, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 51991-759-10 | 51991075910 | 1000 TABLET in 1 BOTTLE (51991-759-10)Marketed from Jun 4, 2011 | |
| 51991-759-33 | 51991075933 | 30 TABLET in 1 BOTTLE (51991-759-33)Marketed from Jun 4, 2011 | |
| 51991-759-90 | 51991075990 | 90 TABLET in 1 BOTTLE (51991-759-90)Marketed from Oct 1, 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)
- Letrozole
- Generic name (nonproprietary)
- letrozole
- Active ingredients
- Letrozole — 2.5 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 200161
- Marketing start
- Listing expires
- Other FDA classes
- Aromatase Inhibitors (Mechanism)
- Identifiers
- Product ID 51991-759_1bd709a7-993a-4e55-9bb5-d5f42678e7b9SPL ID 1bd709a7-993a-4e55-9bb5-d5f42678e7b9SPL set ID 63e54b62-a30d-4a56-9215-75e7a0b0bf02RxCUI 200064UNII 7LKK855W8IUPC 0351991759904
- 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
N451991075910followed by a unit qualifier and the quantityPackage 51991-0759-10. 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 an 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 ind…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 200161
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 | TabletOral | AvPAK | 50268-476 |
| Letrozole | Letrozole 2.5 mg/1 | TabletOral | Natco Pharma Limited | 63850-0025 |
| Letrozole | Letrozole 2.5 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-1526 |
| Letrozole | Letrozole 2.5 mg/1 | TabletOral | A-S Medication Solutions | 50090-8002 |