Nintedanib NDC 69097-639

NDC codes

FDA NDC Directory

Product NDC (as listed)69097-639Labeler and product segments. Claims need a package NDC.

Product NDC at billing width69097-0639Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package	Copy
69097-639-03	69097063903	60 CAPSULE in 1 BOTTLE (69097-639-03)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 — 150 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: Apr 2, 2026
Listing expires: Dec 31, 2027
Other FDA classes: Protein Kinase Inhibitors (Mechanism)
Identifiers: Product ID 69097-639_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

N469097063903 followed by a unit qualifier and the quantity

Package 69097-0639-03. 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 Apr 2, 2026.

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.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 212609

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 212609
Product	Strength	Form · route	Labeler	Product NDC
Nintedanib	Nintedanib esylate 100 mg/1	CapsuleOral	Cipla USA Inc.	69097-641
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