Prescription drug · ANDA
Nintedanib esylate NDC 33342-550
Nintedanib esylate 100 mg/1 · Capsule · Oral · Macleods Pharmaceuticals Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 33342-550-09 | 33342055009 | 60 CAPSULE in 1 BOTTLE (33342-550-09)Marketed from Aug 3, 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 esylate
- Generic name (nonproprietary)
- nintedanib esylate
- Active ingredients
- Nintedanib esylate — 100 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 219926
- Marketing start
- Listing expires
- Other FDA classes
- Protein Kinase Inhibitors (Mechanism)
- Identifiers
- Product ID 33342-550_9925b305-c1fb-43b6-a5fd-e03f14f28e6cSPL ID 9925b305-c1fb-43b6-a5fd-e03f14f28e6cSPL set ID 9925b305-c1fb-43b6-a5fd-e03f14f28e6cRxCUI 1592742, 1592750UNII 42F62RTZ4GUPC 0333342550095, 0333342551092
- 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
N433342055009followed by a unit qualifier and the quantityPackage 33342-0550-09. 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 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 ) 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 diseases (ILDs) with a progressive phenotype [see Clinical Studies ( 14.2 )].
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 219926
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 esylate | Nintedanib esylate 150 mg/1 | CapsuleOral | Macleods Pharmaceuticals Limited | 33342-551 |