Prescription drug · ANDA
Nintedanib NDC 69097-641
Nintedanib esylate 100 mg/1 · Capsule · Oral · Cipla USA Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 69097-641-03 | 69097064103 | 60 CAPSULE in 1 BOTTLE (69097-641-03)Marketed from Apr 2, 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
- Generic name (nonproprietary)
- nintedanib
- Active ingredients
- Nintedanib esylate — 100 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Cipla USA Inc.
- 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 69097-641_128511d3-f076-4a68-993b-53ad52233ee2SPL ID 128511d3-f076-4a68-993b-53ad52233ee2SPL set ID 4d017c42-a823-452d-bc6f-0491dd9823e3RxCUI 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
N469097064103followed by a unit qualifier and the quantityPackage 69097-0641-03. 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.
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 Capsules, 100 mg and 150 mgnintedanib | Nintedanib esylate 100 mg/1 | CapsuleOral | EXELAN PHARMACEUTICALS INC. | 76282-786 |
| Nintedanib Capsules, 100 mg and 150 mgnintedanib | Nintedanib esylate 150 mg/1 | CapsuleOral | EXELAN PHARMACEUTICALS INC. | 76282-787 |