What is NDC 68462-803?

68462-803 is the product NDC for nintedanib, Nintedanib esylate 150 mg/1 capsule, listed with the FDA by Glenmark Pharmaceuticals Inc., USA. It has 1 package NDC, shown above in 10- and 11-digit form.

Glenmark Pharmaceuticals Inc., USA, NDC labeler code 68462. 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.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

nintedanib NDC 68462-803 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)68462-803Labeler and product segments. Claims need a package NDC.

Product NDC at billing width68462-0803Add 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
68462-803-60	6846208036068462080360	1 BOTTLE in 1 CARTON (68462-803-60) / 60 CAPSULE in 1 BOTTLEMarketed from Jul 9, 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: Glenmark Pharmaceuticals Inc., USANDC labeler code 68462
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 212555
Marketing start: Jul 9, 2026
Listing expires: Dec 31, 2027
Other FDA classes: Protein Kinase Inhibitors (Mechanism)
Identifiers: Product ID 68462-803_b14164fb-0276-4ad1-a5ff-400ab9e292daSPL ID b14164fb-0276-4ad1-a5ff-400ab9e292daSPL set ID b14164fb-0276-4ad1-a5ff-400ab9e292daRxCUI 1592742, 1592750UNII 42F62RTZ4GUPC 0368462803608, 0368462802601
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

N468462080360 followed by a unit qualifier and the quantity

Package 68462-0803-60. 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 Jul 10, 2026.

Indications (excerpt from the label)

Nintedanib capsules are 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 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.

Full label on DailyMed (opens in a new tab)

About NDC 68462-803

What is NDC 68462-803?: 68462-803 is the product NDC for nintedanib, Nintedanib esylate 150 mg/1 capsule, listed with the FDA by Glenmark Pharmaceuticals Inc., USA. 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?: Glenmark Pharmaceuticals Inc., USA, NDC labeler code 68462. 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.

Other finished products listed under the same name: strengths, forms and labelers.

Other nintedanib NDCs
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 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
Nintedanib	Nintedanib esylate 150 mg/1	CapsuleOral	Dr. Reddy's Laboratories Inc.	43598-147	43598-0147-60

All 18 nintedanib NDCs

Other NDCs under ANDA 212555

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

FDA NDC Directory listings under ANDA 212555
Product	Strength	Form · route	Labeler	Product NDC
nintedanib	Nintedanib esylate 100 mg/1	CapsuleOral	Glenmark Pharmaceuticals Inc., USA	68462-802
nintedanib	Nintedanib esylate 100 mg/1	CapsuleOral	AvKARE	73190-096
nintedanib	Nintedanib esylate 150 mg/1	CapsuleOral	AvKARE	73190-097