Prescription drug · NDA
Ofev (nintedanib) NDC 0597-0143
Nintedanib esylate 100 mg/1 · Capsule · Oral · Boehringer Ingelheim Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0597-0143-60 | 00597014360 | 1 BOTTLE in 1 CARTON (0597-0143-60) / 60 CAPSULE in 1 BOTTLEMarketed from Oct 17, 2014 |
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)
- Ofev
- Generic name (nonproprietary)
- nintedanib
- Active ingredients
- Nintedanib esylate — 100 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 205832
- Marketing start
- Listing expires
- Other FDA classes
- Protein Kinase Inhibitors (Mechanism)
- Identifiers
- Product ID 0597-0143_5c860918-0d7e-4aaf-b103-85f66e9dcdbeSPL ID 5c860918-0d7e-4aaf-b103-85f66e9dcdbeSPL set ID da1c9f37-779e-4682-816f-93d0faa4cfc9RxCUI 1592742, 1592748, 1592750, 1592752UNII 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
N400597014360followed by a unit qualifier and the quantityPackage 00597-0143-60. 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)
OFEV 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 OFEV is indicated for the treatment of adults with idiopathic pulmonary fibrosis (IPF). 1.2 Chronic Fibrosing Interstitial Lung Diseases with a Progressive Phenotype OFEV is indicated for the treatment of adults with chronic fibrosing interstitial lung diseases (ILDs) with a progressive phenotype [see Clinical St…
Excerpt only. Read the full label for complete information.
Other NDCs under NDA 205832
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 |
|---|---|---|---|---|
| Ofevnintedanib | Nintedanib esylate 150 mg/1 | CapsuleOral | Boehringer Ingelheim Pharmaceuticals, Inc. | 0597-0145 |