Prescription drug · ANDA
Letrozole NDC 59651-180
Letrozole 2.5 mg/1 · Tablet, Film coated · Oral · Aurobindo Pharma Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 59651-180-30 | 59651018030 | 30 TABLET, FILM COATED in 1 BOTTLE (59651-180-30)Marketed from Jan 11, 2019 | |
| 59651-180-90 | 59651018090 | 90 TABLET, FILM COATED in 1 BOTTLE (59651-180-90)Marketed from Jan 11, 2019 |
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, Film coated
- Route
- Oral
- Labeler
- Aurobindo Pharma Limited
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 211717
- Marketing start
- Listing expires
- Other FDA classes
- Aromatase Inhibitors (Mechanism)
- Identifiers
- Product ID 59651-180_2cd5dbfd-2432-4cea-bee2-6b710b5d28a2SPL ID 2cd5dbfd-2432-4cea-bee2-6b710b5d28a2SPL set ID ff7325d2-3383-4ff9-a187-9350e3538640RxCUI 200064UNII 7LKK855W8IUPC 0359651180907, 0359651180303
- 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
N459651018030followed by a unit qualifier and the quantityPackage 59651-0180-30. 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 is 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 indicated fo…
Excerpt only. Read the full label for complete information.