Prescription drug · ANDA
Letrozole NDC 71205-587
Letrozole 2.5 mg/1 · Tablet, Film coated · Oral · Proficient Rx LP
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71205-587-30 | 7120505873071205058730 | 30 TABLET, FILM COATED in 1 BOTTLE (71205-587-30)Marketed from Jul 7, 2021 | |
| 71205-587-60 | 7120505876071205058760 | 60 TABLET, FILM COATED in 1 BOTTLE (71205-587-60)Marketed from Jul 7, 2021 | |
| 71205-587-90 | 7120505879071205058790 | 90 TABLET, FILM COATED in 1 BOTTLE (71205-587-90)Marketed from Jul 7, 2021 |
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
- Proficient Rx LPNDC labeler code 71205
- 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 71205-587_e1390a0d-0280-49a5-a2d4-d2e13e9952caSPL ID e1390a0d-0280-49a5-a2d4-d2e13e9952caSPL set ID e1390a0d-0280-49a5-a2d4-d2e13e9952caRxCUI 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
N471205058730followed by a unit qualifier and the quantityPackage 71205-0587-30. 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 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 …
Excerpt only. Read the full label for complete information.
About NDC 71205-587
- What is NDC 71205-587?
- 71205-587 is the product NDC for Letrozole, Letrozole 2.5 mg/1 tablet, film coated, listed with the FDA by Proficient Rx LP. It has 3 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?
- Proficient Rx LP, NDC labeler code 71205. 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) |
|---|---|---|---|---|---|
| Letrozole | Letrozole 2.5 mg/1 | Tablet, Film coatedOral | Carnegie Pharmaceuticals LLC | 80005-139 | 80005-0139-0880005-0139-10 |
| 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 |
Other NDCs under ANDA 090289
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 | Teva Pharmaceuticals USA, Inc. | 0093-7620 |
| Letrozole | Letrozole 2.5 mg/1 | Tablet, Film coatedOral | AvKARE | 42291-374 |