Prescription drug · ANDA
Letrozole NDC 80005-139
Letrozole 2.5 mg/1 · Tablet, Film coated · Oral · Carnegie Pharmaceuticals LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 80005-139-08 | 8000501390880005013908 | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (80005-139-08)Marketed from Jun 30, 2026 | |
| 80005-139-10 | 8000501391080005013910 | 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (80005-139-10)Marketed from Jun 30, 2026 |
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
- Carnegie Pharmaceuticals LLCNDC labeler code 80005
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 091191
- Marketing start
- Listing expires
- Other FDA classes
- Aromatase Inhibitors (Mechanism)
- Identifiers
- Product ID 80005-139_9fb66539-2efe-47cc-9b78-85b096caac95SPL ID 9fb66539-2efe-47cc-9b78-85b096caac95SPL set ID cb1da0ac-8db1-4482-824d-430511d1b7a0RxCUI 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
N480005013908followed by a unit qualifier and the quantityPackage 80005-0139-08. 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.
About NDC 80005-139
- What is NDC 80005-139?
- 80005-139 is the product NDC for Letrozole, Letrozole 2.5 mg/1 tablet, film coated, listed with the FDA by Carnegie Pharmaceuticals LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Letrozole.
- What is the active ingredient?
- Letrozole.
- Who is the labeler?
- Carnegie Pharmaceuticals LLC, NDC labeler code 80005. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Letrozole?
- 22 other product NDCs are listed under this name. See all Letrozole NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Letrozole products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Letrozoleletrozole tablets | Letrozole 2.5 mg/1 | Tablet, Film coatedOral | Upsher-Smith Laboratories, LLC | 24979-726 | 24979-0726-07 |
| Letrozoleletrozole tablets | Letrozole 2.5 mg/1 | Tablet, Film coatedOral | Avet Pharmaceuticals Inc. | 23155-875 | 23155-0875-0323155-0875-0923155-0875-10 |
| Letrozoleletrozole tablets | Letrozole 2.5 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-2396 | 71335-2396-0171335-2396-0271335-2396-03+1 more |
| Letrozole | Letrozole 2.5 mg/1 | Tablet, Film coatedOral | ATLANTIC BIOLOGICALS CORP. | 17856-0032 | 17856-0032-01 |
| Letrozole | Letrozole 2.5 mg/1 | TabletOral | AvPAK | 50268-476 | 50268-0476-15 |
| Letrozoleletrozole tablets | Letrozole 2.5 mg/1 | Tablet, Film coatedOral | Yiling Pharmaceutical, Inc. | 69117-0004 | 69117-0004-01 |
| Letrozole | Letrozole 2.5 mg/1 | Tablet, Film coatedOral | Chartwell RX, LLC | 62135-491 | 62135-0491-3062135-0491-90 |
| Letrozole | Letrozole 2.5 mg/1 | Tablet, Film coatedOral | Aurobindo Pharma Limited | 59651-180 | 59651-0180-3059651-0180-90 |
| Letrozoleletrozole tablets | Letrozole 2.5 mg/1 | Tablet, Film coatedOral | Golden State Medical Supply, Inc. | 51407-986 | 51407-0986-90 |
| Letrozole | Letrozole 2.5 mg/1 | Tablet, Film coatedOral | AvKARE | 42291-374 | 42291-0374-3042291-0374-90 |
Other NDCs under ANDA 091191
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 | Dr. Reddy's Laboratories Limited | 55111-646 |