Prescription drug · ANDA
Nintedanib Capsules, 100 mg and 150 mg (Nintedanib) NDC 76282-786
Nintedanib esylate 100 mg/1 · Capsule · Oral · EXELAN PHARMACEUTICALS INC.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 76282-786-60 | 7628207866076282078660 | 60 CAPSULE in 1 BOTTLE (76282-786-60)Marketed from May 7, 2026 |
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)
- Nintedanib Capsules, 100 mg and 150 mg
- Generic name (nonproprietary)
- nintedanib
- Active ingredients
- Nintedanib esylate — 100 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- EXELAN PHARMACEUTICALS INC.NDC labeler code 76282
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 212609
- Marketing start
- Listing expires
- Other FDA classes
- Protein Kinase Inhibitors (Mechanism)
- Identifiers
- Product ID 76282-786_e6cab487-5092-4b7b-a3c2-da94f6dc66c2SPL ID e6cab487-5092-4b7b-a3c2-da94f6dc66c2SPL set ID 60d8104e-cb6c-4f4f-8159-95ed57346ffaRxCUI 1592742, 1592750UNII 42F62RTZ4GUPC 0057200006189
- 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
N476282078660followed by a unit qualifier and the quantityPackage 76282-0786-60. 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 is 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 capsule is indicated for the treatment of adults with idiopathic pulmonary fibrosis (IPF). 1.2 Chronic Fibrosing Interstitial Lung Diseases with a Progressive Phenotype Nintedanib capsule is indicated for the treatment of adults with chronic fibrosing interstitial lung diseases (ILDs) with a p…
Excerpt only. Read the full label for complete information.
About NDC 76282-786
- What is NDC 76282-786?
- 76282-786 is the product NDC for Nintedanib Capsules, 100 mg and 150 mg, Nintedanib esylate 100 mg/1 capsule, listed with the FDA by EXELAN PHARMACEUTICALS INC.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Nintedanib Capsules, 100 mg and 150 mg (Nintedanib).
- What is the active ingredient?
- Nintedanib esylate.
- Who is the labeler?
- EXELAN PHARMACEUTICALS INC., NDC labeler code 76282. 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 Capsules, 100 mg and 150 mg?
- 1 other product NDC are listed under this name. See all Nintedanib Capsules, 100 mg and 150 mg NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Nintedanib Capsules, 100 mg and 150 mg 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 Capsules, 100 mg and 150 mgnintedanib | Nintedanib esylate 150 mg/1 | CapsuleOral | EXELAN PHARMACEUTICALS INC. | 76282-787 | 76282-0787-60 |
Other NDCs under ANDA 212609
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 | Cipla USA Inc. | 69097-639 |
| Nintedanib | Nintedanib esylate 100 mg/1 | CapsuleOral | Cipla USA Inc. | 69097-641 |
| Nintedanib Capsules, 100 mg and 150 mgnintedanib | Nintedanib esylate 150 mg/1 | CapsuleOral | EXELAN PHARMACEUTICALS INC. | 76282-787 |