Prescription drug · ANDA
Letrozole NDC 16729-034
Letrozole 2.5 mg/1 · Tablet, Film coated · Oral · Accord Healthcare, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 16729-034-10 | 1672900341016729003410 | 30 TABLET, FILM COATED in 1 BOTTLE (16729-034-10)Marketed from Jun 2, 2011 | |
| 16729-034-15 | 1672900341516729003415 | 90 TABLET, FILM COATED in 1 BOTTLE (16729-034-15)Marketed from Dec 31, 2014 |
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
- Accord Healthcare, Inc.NDC labeler code 16729
- 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 16729-034_4a681bf4-9779-a1b2-e063-6294a90a83dbSPL ID 4a681bf4-9779-a1b2-e063-6294a90a83dbSPL set ID c391fe11-fd47-4a35-af6d-c823ab7b8838RxCUI 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
N416729003410followed by a unit qualifier and the quantityPackage 16729-0034-10. 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.
About NDC 16729-034
- What is NDC 16729-034?
- 16729-034 is the product NDC for Letrozole, Letrozole 2.5 mg/1 tablet, film coated, listed with the FDA by Accord Healthcare, Inc.. 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?
- Accord Healthcare, Inc., NDC labeler code 16729. 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 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 | ATLANTIC BIOLOGICALS CORP. | 17856-0032 |
| Letrozole | Letrozole 2.5 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-3474 |
| Letrozole | Letrozole 2.5 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 63629-7819 |
| Letrozole | Letrozole 2.5 mg/1 | Tablet, Film coatedOral | NuCare Pharmaceuticals,Inc. | 68071-2167 |
| Letrozole | Letrozole 2.5 mg/1 | Tablet, Film coatedOral | NuCare Pharmaceuticals,Inc. | 68071-5264 |