Prescription drug · ANDA
Letrozole NDC 0093-7620
Letrozole 2.5 mg/1 · Tablet, Film coated · Oral · Teva Pharmaceuticals USA, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0093-7620-56 | 00093762056 | 30 TABLET, FILM COATED in 1 BOTTLE (0093-7620-56)Marketed from Jun 3, 2011 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 090289
- Marketing start
- Listing expires
- Other FDA classes
- Aromatase Inhibitors (Mechanism)
- Identifiers
- Product ID 0093-7620_c91fb703-e253-490e-bb1d-48d054d81c6eSPL ID c91fb703-e253-490e-bb1d-48d054d81c6eSPL set ID 8ebda73d-82a3-4b17-8a81-a1f258003d32RxCUI 200064UNII 7LKK855W8IUPC 0300937620563
- 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
N400093762056followed by a unit qualifier and the quantityPackage 00093-7620-56. 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 090289
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.