What is NDC 0378-8030?

0378-8030 is the product NDC for Lansoprazole, Lansoprazole 30 mg/1 capsule, delayed release pellets, listed with the FDA by Mylan Pharmaceuticals Inc.. It has 3 package NDCs, shown above in 10- and 11-digit form.

Mylan Pharmaceuticals Inc., NDC labeler code 0378. 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?

94 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 0378-8030 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)0378-8030Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00378-8030Add 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
0378-8030-05	0037880300500378803005	500 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE, PLASTIC (0378-8030-05)Marketed from Nov 10, 2009
0378-8030-77	0037880307700378803077	90 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE, PLASTIC (0378-8030-77)Marketed from Nov 10, 2009
0378-8030-93	0037880309300378803093	30 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE, PLASTIC (0378-8030-93)Marketed from Nov 10, 2009

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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 — 30 mg/1
Dosage form: Capsule, Delayed release pellets
Route: Oral
Labeler: Mylan Pharmaceuticals Inc.NDC labeler code 0378
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 090763
Marketing start: Nov 10, 2009
Listing expires: Dec 31, 2027
Other FDA classes: Inhibition Gastric Acid Secretion (Physiologic effect)Proton Pump Inhibitors (Mechanism)
Identifiers: Product ID 0378-8030_810def72-c1da-4c4d-9939-32b29be79e0cSPL ID 810def72-c1da-4c4d-9939-32b29be79e0cSPL set ID c8fa7401-907f-41b6-a2e1-f4bc214f2cdfRxCUI 311277, 596843UNII 0K5C5T2QPGUPC 0303788030932, 0303788015939
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

N400378803005 followed by a unit qualifier and the quantity

Package 00378-8030-05. 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 Sep 15, 2024.

Indications (excerpt from the label)

Lansoprazole delayed-release capsules are a proton pump inhibitor (PPI) 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 esophagitis…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0378-8030

What is NDC 0378-8030?: 0378-8030 is the product NDC for Lansoprazole, Lansoprazole 30 mg/1 capsule, delayed release pellets, listed with the FDA by Mylan Pharmaceuticals Inc.. It has 3 package NDCs, 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?: Mylan Pharmaceuticals Inc., NDC labeler code 0378. 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?: 94 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 15 mg/1	Capsule, Delayed releaseOral	Macleods Pharmaceuticals Limited	33342-310	33342-0310-07
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

All 95 Lansoprazole NDCs

Other NDCs under ANDA 090763

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

FDA NDC Directory listings under ANDA 090763
Product	Strength	Form · route	Labeler	Product NDC
Lansoprazole	Lansoprazole 15 mg/1	Capsule, Delayed release pelletsOral	Mylan Pharmaceuticals Inc.	0378-8015
Lansoprazole	Lansoprazole 30 mg/1	Capsule, Delayed release pelletsOral	Safecor Health LLC	48433-051
Lansoprazole	Lansoprazole 30 mg/1	Capsule, Delayed release pelletsOral	Mylan Institutional Inc.	51079-121
Lansoprazole	Lansoprazole 30 mg/1	Capsule, Delayed release pelletsOral	Preferred Pharmaceuticals Inc.	68788-4141