What is NDC 33342-310?

33342-310 is the product NDC for Lansoprazole, Lansoprazole 15 mg/1 capsule, delayed release, 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 Lansoprazole?

97 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Lansoprazole NDC 33342-310 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)33342-310Labeler and product segments. Claims need a package NDC.

Product NDC at billing width33342-0310Add 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
33342-310-07	33342031007	30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (33342-310-07)Marketed from Nov 5, 2024

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): Lansoprazole
Generic name (nonproprietary): lansoprazole
Active ingredients: Lansoprazole — 15 mg/1
Dosage form: Capsule, Delayed release
Route: Oral
Labeler: Macleods Pharmaceuticals LimitedNDC labeler code 33342
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 208671
Marketing start: Nov 5, 2024
Listing expires: Dec 31, 2026
Other FDA classes: Inhibition Gastric Acid Secretion (Physiologic effect)Proton Pump Inhibitors (Mechanism)
Identifiers: Product ID 33342-310_75691c2d-2265-4153-bc3a-4f7d5d51e250SPL ID 75691c2d-2265-4153-bc3a-4f7d5d51e250SPL set ID 75691c2d-2265-4153-bc3a-4f7d5d51e250RxCUI 311277, 596843UNII 0K5C5T2QPGUPC 0333342310071, 0333342311078
Pharmacologic class: Proton Pump 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

N433342031007 followed by a unit qualifier and the quantity

Package 33342-0310-07. 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 Dec 2, 2024.

Indications (excerpt from the label)

Lansoprazole delayed-release capsules, are a proton pump inhibitors (PPIs) indicated for the: • Treatment of active duodenal ulcer in adults. ( 1.1 ) • Eradication of H. pylori to reduce the risk of duodenal ulcer recurrence in adults. ( 1.2 ) • Maintenance of healed duodenal ulcers in adults. ( 1.3 ) • Treatment of active benign gastric ulcer in adults. ( 1.4 ) • Healing of nonsteroidal anti-inflammatory drugs (NSAID)- associated gastric ulcer in adults. ( 1.5 ) • Risk reduction of NSAID-associated gastric ulcer in adults. ( 1.6 ) • Treatment of symptomatic gastroesophageal reflux disease (GERD) in adults and pediatric patients 1 year of age and older. ( 1.7 ) • Treatment of erosive esophag…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 33342-310

What is NDC 33342-310?: 33342-310 is the product NDC for Lansoprazole, Lansoprazole 15 mg/1 capsule, delayed release, 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?: Lansoprazole.
What is the active ingredient?: Lansoprazole.
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 Lansoprazole?: 97 other product NDCs are listed under this name. See all Lansoprazole 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 Lansoprazole NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Lansoprazole	Lansoprazole 30 mg/1	Tablet, Orally disintegrating, Delayed releaseOral	Cardinal Health 107, LLC	55154-8340	55154-8340-00
Lansoprazole	Lansoprazole 30 mg/1	Capsule, Delayed release pelletsOral	Preferred Pharmaceuticals Inc.	68788-4141	68788-4141-0368788-4141-0668788-4141-09
Lansoprazole	Lansoprazole 15 mg/1	Tablet, Orally disintegrating, Delayed releaseOral	Amazon.com Services LLC	72288-672	72288-0672-55
Lansoprazole	Lansoprazole 15 mg/1	Capsule, Delayed releaseOral	Amazon.com Services LLC	72288-827	72288-0827-03
Lansoprazole	Lansoprazole 30 mg/1	Capsule, Delayed release pelletsOral	Safecor Health LLC	48433-051	48433-0051-08
Lansoprazole	Lansoprazole 30 mg/1	Capsule, Delayed releaseOral	Medcore LLC	82461-713	82461-0713-30
Lansoprazole	Lansoprazole 30 mg/1	Capsule, Delayed releaseOral	Macleods Pharmaceuticals Limited	33342-311	33342-0311-07
Lansoprazole	Lansoprazole 30 mg/1	Capsule, Delayed releaseOral	Preferred Pharmaceuticals Inc.	68788-8621	68788-8621-0168788-8621-0368788-8621-06+2 more
Lansoprazole	Lansoprazole 15 mg/1	Tablet, Orally disintegrating, Delayed releaseOral	Aurobindo Pharma Limited	65862-895	65862-0895-78
Lansoprazole	Lansoprazole 30 mg/1	Tablet, Orally disintegrating, Delayed releaseOral	Aurobindo Pharma Limited	65862-896	65862-0896-78

All 98 Lansoprazole NDCs

Other NDCs under ANDA 208671

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

FDA NDC Directory listings under ANDA 208671
Product	Strength	Form · route	Labeler	Product NDC
Lansoprazole	Lansoprazole 30 mg/1	Capsule, Delayed releaseOral	Macleods Pharmaceuticals Limited	33342-311