Prescription drug · ANDA
nintedanib NDC 0781-2495
Nintedanib esylate 150 mg/1 · Capsule · Oral · Sandoz Inc
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0781-2495-60 | 0078124956000781249560 | 60 CAPSULE in 1 BOTTLE (0781-2495-60)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 — 150 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Sandoz IncNDC labeler code 0781
- 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 0781-2495_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
N400781249560followed by a unit qualifier and the quantityPackage 00781-2495-60. 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
Current FDA label (SPL), effective .
Indications (excerpt from the label)
Nintedanib capsules are a kinase inhibitor indicated in adults for: • Treatment of idiopathic pulmonary fibrosis (IPF) ( 1.1 ) • Treatment of chronic fibrosing interstitial lung diseases (ILDs) with a progressive phenotype ( 1.2 ) • Slowing the rate of decline in pulmonary function in patients with systemic sclerosis-associated interstitial lung disease (SSc-ILD) ( 1.3 ) 1.1 Idiopathic Pulmonary Fibrosis Nintedanib capsules are indicated for the treatment of adults with idiopathic pulmonary fibrosis (IPF). 1.2 Chronic Fibrosing Interstitial Lung Diseases with a Progressive Phenotype Nintedanib capsules are indicated for the treatment of adults with chronic fibrosing interstitial lung disease…
Excerpt only. Read the full label for complete information.
About NDC 0781-2495
- What is NDC 0781-2495?
- 0781-2495 is the product NDC for nintedanib, Nintedanib esylate 150 mg/1 capsule, listed with the FDA by Sandoz Inc. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- nintedanib.
- What is the active ingredient?
- Nintedanib esylate.
- Who is the labeler?
- Sandoz Inc, NDC labeler code 0781. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for nintedanib?
- 17 other product NDCs are listed under this name. See all nintedanib NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other nintedanib products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| nintedanib | Nintedanib esylate 100 mg/1 | CapsuleOral | AvKARE | 73190-096 | 73190-0096-60 |
| nintedanib | Nintedanib esylate 150 mg/1 | CapsuleOral | AvKARE | 73190-097 | 73190-0097-60 |
| nintedanib | Nintedanib esylate 150 mg/1 | CapsuleOral | EPIC PHARMA LLC | 42806-568 | 42806-0568-60 |
| nintedanib | Nintedanib esylate 100 mg/1 | CapsuleOral | EPIC PHARMA LLC | 42806-569 | 42806-0569-60 |
| nintedanib | Nintedanib esylate 100 mg/1 | CapsuleOral | Glenmark Pharmaceuticals Inc., USA | 68462-802 | 68462-0802-60 |
| nintedanib | Nintedanib esylate 150 mg/1 | CapsuleOral | Glenmark Pharmaceuticals Inc., USA | 68462-803 | 68462-0803-60 |
| Nintedanib | Nintedanib esylate 100 mg/1 | CapsuleOral | Edenbridge Pharmaceuticals LLC. | 42799-972 | 42799-0972-01 |
| Nintedanib | Nintedanib esylate 150 mg/1 | CapsuleOral | Edenbridge Pharmaceuticals LLC. | 42799-973 | 42799-0973-01 |
| nintedanib | Nintedanib esylate 100 mg/1 | CapsuleOral | Sandoz Inc | 0781-2492 | 00781-2492-60 |
| Nintedanib | Nintedanib esylate 150 mg/1 | CapsuleOral | Dr. Reddy's Laboratories Inc. | 43598-147 | 43598-0147-60 |
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 100 mg/1 | CapsuleOral | Sandoz Inc | 0781-2492 |