Prescription drug · ANDA
Nintedanib NDC 51407-984
Nintedanib esylate 100 mg/1 · Capsule · Oral · Golden State Medical Supply, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 51407-984-60 | 5140709846051407098460 | 60 CAPSULE in 1 BOTTLE (51407-984-60)Marketed from Feb 15, 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
- Golden State Medical Supply, Inc.NDC labeler code 51407
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 219819
- Marketing start
- Listing expires
- Other FDA classes
- Protein Kinase Inhibitors (Mechanism)
- Identifiers
- Product ID 51407-984_57d8ab30-2f82-498f-e063-6394a90a81aaSPL ID 57d8ab30-2f82-498f-e063-6394a90a81aaSPL set ID 4ecf7f05-4a95-b98c-e063-6394a90ab896RxCUI 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
N451407098460followed by a unit qualifier and the quantityPackage 51407-0984-60. 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 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 ) 1.1 Idiopathic Pulmonary Fibrosis Nintedanib Capsules is indicated for the treatment of adults with idiopathic pulmonary fibrosis (IPF). 1.2 Chronic Fibrosing Interstitial Lung Diseases with a Progressive Phenotype Nintedanib Capsules is 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.
About NDC 51407-984
- What is NDC 51407-984?
- 51407-984 is the product NDC for Nintedanib, Nintedanib esylate 100 mg/1 capsule, listed with the FDA by Golden State Medical Supply, 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?
- Golden State Medical Supply, Inc., NDC labeler code 51407. 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 | Sandoz Inc | 0781-2495 | 00781-2495-60 |
Other NDCs under ANDA 219819
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 | Edenbridge Pharmaceuticals LLC. | 42799-972 |
| Nintedanib | Nintedanib esylate 150 mg/1 | CapsuleOral | Edenbridge Pharmaceuticals LLC. | 42799-973 |
| Nintedanib | Nintedanib esylate 150 mg/1 | CapsuleOral | Golden State Medical Supply, Inc. | 51407-985 |