Prescription drug · ANDA
nintedanib NDC 0781-2492
Nintedanib esylate 100 mg/1 · Capsule · Oral · Sandoz Inc
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0781-2492-60 | 00781249260 | 60 CAPSULE in 1 BOTTLE (0781-2492-60)Marketed from Apr 2, 2026 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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)
- nintedanib
- Generic name (nonproprietary)
- nintedanib
- Active ingredients
- Nintedanib esylate — 100 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Sandoz Inc
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 216915
- Marketing start
- Listing expires
- Other FDA classes
- Protein Kinase Inhibitors (Mechanism)
- Identifiers
- Product ID 0781-2492_93bd44f8-ed32-4607-8d02-56a219263dd4SPL ID 93bd44f8-ed32-4607-8d02-56a219263dd4SPL set ID 751c3473-35d6-47d6-b405-af16a989716cRxCUI 1592742, 1592750UNII 42F62RTZ4G
- Pharmacologic class
- Kinase 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
N400781249260followed by a unit qualifier and the quantityPackage 00781-2492-60. 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.
Other NDCs under ANDA 216915
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 |
|---|---|---|---|---|
| nintedanib | Nintedanib esylate 150 mg/1 | CapsuleOral | Sandoz Inc | 0781-2495 |