Prescription drug · ANDA
Letrozole NDC 17856-0032
Letrozole 2.5 mg/1 · Tablet, Film coated · Oral · ATLANTIC BIOLOGICALS CORP.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 17856-0032-1 | 17856003201 | 100 POUCH in 1 BOX, UNIT-DOSE (17856-0032-1) / 1 TABLET, FILM COATED in 1 POUCHMarketed from Jan 13, 2020 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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
- ATLANTIC BIOLOGICALS CORP.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 090934
- Marketing start
- Listing expires
- Other FDA classes
- Aromatase Inhibitors (Mechanism)
- Identifiers
- Product ID 17856-0032_38546ba0-8feb-9cf6-e063-6294a90a074cSPL ID 38546ba0-8feb-9cf6-e063-6294a90a074cSPL set ID c10bf97f-f9cf-468a-8a1f-7637f41022e4RxCUI 200064UNII 7LKK855W8I
- 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
N417856003201followed by a unit qualifier and the quantityPackage 17856-0032-01. 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 tablet 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 indicate…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 090934
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 | NuCare Pharmaceuticals,Inc. | 68071-2167 |
| Letrozole | Letrozole 2.5 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-3474 |
| Letrozole | Letrozole 2.5 mg/1 | Tablet, Film coatedOral | NuCare Pharmaceuticals,Inc. | 68071-5264 |
| Letrozole | Letrozole 2.5 mg/1 | Tablet, Film coatedOral | Accord Healthcare, Inc. | 16729-034 |
| Letrozole | Letrozole 2.5 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 63629-7819 |