NDC codes

FDA NDC Directory
Product NDC (as listed)68001-111Labeler and product segments. Claims need a package NDC.
Product NDC at billing width68001-0111Add 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 NDC11-digit (billing)PackageCopy
68001-111-04680010111046800101110430 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68001-111-04)Marketed from Dec 1, 2013
68001-111-05680010111056800101110590 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68001-111-05)Marketed from Dec 1, 2013

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
BluePoint LaboratoriesNDC labeler code 68001
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 091269
Marketing start
Listing expires
Other FDA classes
Inhibition Gastric Acid Secretion (Physiologic effect)Proton Pump Inhibitors (Mechanism)
Identifiers
Product ID 68001-111_e1e35404-0cf3-e40d-e053-2995a90a3829SPL ID e1e35404-0cf3-e40d-e053-2995a90a3829SPL set ID 924c5a35-4804-4e14-a2fc-2b84d186d257RxCUI 311277, 596843UNII 0K5C5T2QPGUPC 0368001111058, 0368001112048
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

N468001011104 followed by a unit qualifier and the quantity

Package 68001-0111-04. 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 .

Indications (excerpt from the label)

Lansoprazole delayed-release capsule is a proton pump inhibitor (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 esophagitis (EE) in adults and ped…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 68001-111

What is NDC 68001-111?
68001-111 is the product NDC for Lansoprazole, Lansoprazole 15 mg/1 capsule, delayed release, listed with the FDA by BluePoint Laboratories. It has 2 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?
BluePoint Laboratories, NDC labeler code 68001. 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
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
LansoprazoleLansoprazole 30 mg/1Tablet, Orally disintegrating, Delayed releaseOralCardinal Health 107, LLC55154-834055154-8340-00
LansoprazoleLansoprazole 15 mg/1Tablet, Orally disintegrating, Delayed releaseOralAmazon.com Services LLC72288-67272288-0672-55
LansoprazoleLansoprazole 30 mg/1Capsule, Delayed release pelletsOralPreferred Pharmaceuticals Inc.68788-414168788-4141-0368788-4141-0668788-4141-09
LansoprazoleLansoprazole 15 mg/1Capsule, Delayed releaseOralAmazon.com Services LLC72288-82772288-0827-03
LansoprazoleLansoprazole 30 mg/1Capsule, Delayed release pelletsOralSafecor Health LLC48433-05148433-0051-08
LansoprazoleLansoprazole 30 mg/1Capsule, Delayed releaseOralMedcore LLC82461-71382461-0713-30
LansoprazoleLansoprazole 30 mg/1Capsule, Delayed releaseOralMacleods Pharmaceuticals Limited33342-31133342-0311-07
LansoprazoleLansoprazole 15 mg/1Capsule, Delayed releaseOralMacleods Pharmaceuticals Limited33342-31033342-0310-07
LansoprazoleLansoprazole 30 mg/1Capsule, Delayed releaseOralPreferred Pharmaceuticals Inc.68788-862168788-8621-0168788-8621-0368788-8621-06+2 more
LansoprazoleLansoprazole 15 mg/1Tablet, Orally disintegrating, Delayed releaseOralNorthStar Rx LLC72603-31372603-0313-10

All 95 Lansoprazole NDCs

Other NDCs under ANDA 091269

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

FDA NDC Directory listings under ANDA 091269
ProductStrengthForm · routeLabelerProduct NDC
LansoprazoleLansoprazole 30 mg/1Capsule, Delayed releaseOralRedpharm Drug67296-2270
LansoprazoleLansoprazole 15 mg/1Capsule, Delayed releaseOralDr.Reddy's Laboratories Ltd.55111-398
LansoprazoleLansoprazole 30 mg/1Capsule, Delayed releaseOralDr.Reddy's Laboratories Ltd.55111-399
LansoprazoleLansoprazole 15 mg/1Capsule, Delayed releaseOralBryant Ranch Prepack71335-2957
LansoprazoleLansoprazole 30 mg/1Capsule, Delayed releaseOralProficient Rx LP63187-510
LansoprazoleLansoprazole 15 mg/1Capsule, Delayed releaseOralBryant Ranch Prepack71335-0058
LansoprazoleLansoprazole 30 mg/1Capsule, Delayed releaseOralMajor Pharmaceuticals0904-6662
LansoprazoleLansoprazole 15 mg/1Capsule, Delayed releaseOralPreferred Pharmaceuticals Inc.68788-6390
LansoprazoleLansoprazole 15 mg/1Capsule, Delayed releaseOralNuCare Pharmaceuticals,Inc.68071-4456
Lansoprazole DRlansoprazoleLansoprazole 15 mg/1Capsule, Delayed releaseOralAdvanced Rx Pharmacy of Tennessee, LLC80425-0148
LansoprazoleLansoprazole 30 mg/1Capsule, Delayed releaseOralA-S Medication Solutions50090-6830
LansoprazoleLansoprazole 15 mg/1Capsule, Delayed releaseOralAmerican Health Packaging60687-111
LansoprazoleLansoprazole 30 mg/1Capsule, Delayed releaseOralAmerican Health Packaging60687-123
LansoprazoleLansoprazole 15 mg/1Capsule, Delayed releaseOralNuCare Pharmaceuticals,Inc.68071-3687
LansoprazoleLansoprazole 30 mg/1Capsule, Delayed releaseOralBluePoint Laboratories68001-112

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