Prescription drug · ANDA
Letrozole (Letrozole tablets) NDC 69117-0004
Letrozole 2.5 mg/1 · Tablet, Film coated · Oral · Yiling Pharmaceutical, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 69117-0004-1 | 6911700040169117000401 | 30 TABLET, FILM COATED in 1 BOTTLE (69117-0004-1)Marketed from Sep 5, 2019 · Sample package |
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 tablets
- Active ingredients
- Letrozole — 2.5 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Yiling Pharmaceutical, Inc.NDC labeler code 69117
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 205869
- Marketing start
- Listing expires
- Other FDA classes
- Aromatase Inhibitors (Mechanism)
- Identifiers
- Product ID 69117-0004_4721d1b1-3a04-27fb-e063-6394a90a7c1aSPL ID 4721d1b1-3a04-27fb-e063-6394a90a7c1aSPL set ID 7b00e08c-9a1c-09e0-e053-2a91aa0a7638RxCUI 200064UNII 7LKK855W8IUPC 0369117000410
- 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
N469117000401followed by a unit qualifier and the quantityPackage 69117-0004-01. 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, USP are 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, USP 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, US…
Excerpt only. Read the full label for complete information.
About NDC 69117-0004
- What is NDC 69117-0004?
- 69117-0004 is the product NDC for Letrozole (letrozole tablets), Letrozole 2.5 mg/1 tablet, film coated, listed with the FDA by Yiling Pharmaceutical, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Letrozole (Letrozole Tablets).
- What is the active ingredient?
- Letrozole.
- Who is the labeler?
- Yiling Pharmaceutical, Inc., NDC labeler code 69117. 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 |
| 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 205869
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 |
|---|---|---|---|---|
| Letrozoleletrozole tablets | Letrozole 2.5 mg/1 | Tablet, Film coatedOral | Avet Pharmaceuticals Inc. | 23155-875 |
| Letrozoleletrozole tablets | Letrozole 2.5 mg/1 | Tablet, Film coatedOral | Upsher-Smith Laboratories, LLC | 24979-726 |
| Letrozoleletrozole tablets | Letrozole 2.5 mg/1 | Tablet, Film coatedOral | Golden State Medical Supply, Inc. | 51407-986 |
| Letrozole | Letrozole 2.5 mg/1 | Tablet, Film coatedOral | Chartwell RX, LLC | 62135-491 |
| Letrozoleletrozole tablets | Letrozole 2.5 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-2396 |