Prescription drug · ANDA
Varenicline Tartrate NDC 69315-404
Kit · Leading Pharma, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 69315-404-57 | 69315040457 | 1 KIT in 1 BOX (69315-404-57) * 11 TABLET, FILM COATED in 1 BLISTER PACK * 42 TABLET, FILM COATED in 1 BLISTER PACKMarketed from Oct 1, 2023 |
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)
- Varenicline Tartrate
- Generic name (nonproprietary)
- varenicline tartrate
- Dosage form
- Kit
- Labeler
- Leading Pharma, LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 217151
- Marketing start
- Listing expires
- Identifiers
- Product ID 69315-404_cd15d74e-92d3-4bf0-8c76-a01f9190b172SPL ID cd15d74e-92d3-4bf0-8c76-a01f9190b172SPL set ID fdb36cfa-d20a-4fd9-b994-a5d16e4bb438RxCUI 636671, 636676, 749289, 749788UNII 82269ASB48UPC 0369315403563, 0369315402566
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 drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.
- NDC on a medical claim
N469315040457followed by a unit qualifier and the quantityPackage 69315-0404-57. 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
Label details couldn’t be retrieved right now. Open the label on DailyMed.