What is NDC 33342-551?

33342-551 is the product NDC for Nintedanib esylate, Nintedanib esylate 150 mg/1 capsule, listed with the FDA by Macleods Pharmaceuticals Limited. It has 1 package NDC, shown above in 10- and 11-digit form.

Macleods Pharmaceuticals Limited, NDC labeler code 33342. 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 esylate?

1 other product NDC are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Nintedanib esylate NDC 33342-551 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)33342-551Labeler and product segments. Claims need a package NDC.

Product NDC at billing width33342-0551Add 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
33342-551-09	3334205510933342055109	60 CAPSULE in 1 BOTTLE (33342-551-09)Marketed from Aug 3, 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 esylate
Generic name (nonproprietary): nintedanib esylate
Active ingredients: Nintedanib esylate — 150 mg/1
Dosage form: Capsule
Route: Oral
Labeler: Macleods Pharmaceuticals LimitedNDC labeler code 33342
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 219926
Marketing start: Aug 3, 2026
Listing expires: Dec 31, 2027
Other FDA classes: Protein Kinase Inhibitors (Mechanism)
Identifiers: Product ID 33342-551_9925b305-c1fb-43b6-a5fd-e03f14f28e6cSPL ID 9925b305-c1fb-43b6-a5fd-e03f14f28e6cSPL set ID 9925b305-c1fb-43b6-a5fd-e03f14f28e6cRxCUI 1592742, 1592750UNII 42F62RTZ4GUPC 0333342550095, 0333342551092
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

N433342055109 followed by a unit qualifier and the quantity

Package 33342-0551-09. 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 Aug 3, 2026.

Indications (excerpt from the label)

Nintedanib capsules are 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 33342-551

What is NDC 33342-551?: 33342-551 is the product NDC for Nintedanib esylate, Nintedanib esylate 150 mg/1 capsule, listed with the FDA by Macleods Pharmaceuticals Limited. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Nintedanib esylate.
What is the active ingredient?: Nintedanib esylate.
Who is the labeler?: Macleods Pharmaceuticals Limited, NDC labeler code 33342. 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 esylate?: 1 other product NDC are listed under this name. See all Nintedanib esylate 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 esylate NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Nintedanib esylate	Nintedanib esylate 100 mg/1	CapsuleOral	Macleods Pharmaceuticals Limited	33342-550	33342-0550-09

Other NDCs under ANDA 219926

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

FDA NDC Directory listings under ANDA 219926
Product	Strength	Form · route	Labeler	Product NDC
Nintedanib esylate	Nintedanib esylate 100 mg/1	CapsuleOral	Macleods Pharmaceuticals Limited	33342-550