Prescription drug · ANDA
Letrozole NDC 63850-0025
Letrozole 2.5 mg/1 · Tablet · Oral · Natco Pharma Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63850-0025-1 | 6385000250163850002501 | 30 TABLET in 1 BOTTLE (63850-0025-1)Marketed from Jun 3, 2011 | |
| 63850-0025-4 | 6385000250463850002504 | 1000 TABLET in 1 BOTTLE (63850-0025-4)Marketed from Jun 3, 2011 |
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
- Route
- Oral
- Labeler
- Natco Pharma LimitedNDC labeler code 63850
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 200161
- Marketing start
- Listing expires
- Other FDA classes
- Aromatase Inhibitors (Mechanism)
- Identifiers
- Product ID 63850-0025_7917d6e0-df93-4c10-97c9-3d90b00b7bd4SPL ID 7917d6e0-df93-4c10-97c9-3d90b00b7bd4SPL set ID 35c73219-c39e-4e10-b944-76009b061e79RxCUI 200064UNII 7LKK855W8IUPC 0363850002540
- 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
N463850002501followed by a unit qualifier and the quantityPackage 63850-0025-01. 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 tablets are an aromatase inhibitor indicated for: Adjuvant treatment of posmenopausal 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 indicat…
Excerpt only. Read the full label for complete information.
About NDC 63850-0025
- What is NDC 63850-0025?
- 63850-0025 is the product NDC for Letrozole, Letrozole 2.5 mg/1 tablet, listed with the FDA by Natco Pharma Limited. 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?
- Natco Pharma Limited, NDC labeler code 63850. 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 200161
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 | TabletOral | A-S Medication Solutions | 50090-8002 |
| Letrozole | Letrozole 2.5 mg/1 | TabletOral | AvPAK | 50268-476 |
| Letrozole | Letrozole 2.5 mg/1 | TabletOral | Breckenridge Pharmaceutical, Inc. | 51991-759 |
| Letrozole | Letrozole 2.5 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-1526 |