Nintedanib Capsules, 100 mg and 150 mg NDC 76282-787

NDC codes

FDA NDC Directory

Product NDC (as listed)76282-787Labeler and product segments. Claims need a package NDC.

Product NDC at billing width76282-0787Add 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
76282-787-60	76282078760	60 CAPSULE in 1 BOTTLE (76282-787-60)Marketed from May 7, 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 Capsules, 100 mg and 150 mg
Generic name (nonproprietary): nintedanib
Active ingredients: Nintedanib esylate — 150 mg/1
Dosage form: Capsule
Route: Oral
Labeler: EXELAN PHARMACEUTICALS INC.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 212609
Marketing start: May 7, 2026
Listing expires: Dec 31, 2027
Other FDA classes: Protein Kinase Inhibitors (Mechanism)
Identifiers: Product ID 76282-787_e6cab487-5092-4b7b-a3c2-da94f6dc66c2SPL ID e6cab487-5092-4b7b-a3c2-da94f6dc66c2SPL set ID 60d8104e-cb6c-4f4f-8159-95ed57346ffaRxCUI 1592742, 1592750UNII 42F62RTZ4GUPC 0057200006189
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

N476282078760 followed by a unit qualifier and the quantity

Package 76282-0787-60. 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 Apr 21, 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	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