NDC codes

FDA NDC Directory
Product NDC (as listed)68788-8621Labeler and product segments. Claims need a package NDC.
Product NDC at billing width68788-8621Add 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
68788-8621-1687888621016878886210114 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68788-8621-1)Marketed from Apr 5, 2024
68788-8621-3687888621036878886210330 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68788-8621-3)Marketed from Apr 4, 2024
68788-8621-6687888621066878886210660 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68788-8621-6)Marketed from Apr 4, 2024
68788-8621-86878886210868788862108120 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68788-8621-8)Marketed from Apr 4, 2024
68788-8621-9687888621096878886210990 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68788-8621-9)Marketed from Apr 4, 2024

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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
Route
Oral
Labeler
Preferred Pharmaceuticals Inc.NDC labeler code 68788
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 203203
Marketing start
Listing expires
Other FDA classes
Inhibition Gastric Acid Secretion (Physiologic effect)Proton Pump Inhibitors (Mechanism)
Identifiers
Product ID 68788-8621_1ac77078-81ea-4a66-ba61-660886a99d74SPL ID 1ac77078-81ea-4a66-ba61-660886a99d74SPL set ID db42468a-450c-4b12-b2f2-e9a76e976d45RxCUI 311277UNII 0K5C5T2QPG
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

N468788862101 followed by a unit qualifier and the quantity

Package 68788-8621-01. 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 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 (EE) …

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 68788-8621

What is NDC 68788-8621?
68788-8621 is the product NDC for Lansoprazole, Lansoprazole 30 mg/1 capsule, delayed release, listed with the FDA by Preferred Pharmaceuticals Inc.. It has 5 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?
Preferred Pharmaceuticals Inc., NDC labeler code 68788. 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 30 mg/1Capsule, Delayed release pelletsOralPreferred Pharmaceuticals Inc.68788-414168788-4141-0368788-4141-0668788-4141-09
LansoprazoleLansoprazole 15 mg/1Tablet, Orally disintegrating, Delayed releaseOralAmazon.com Services LLC72288-67272288-0672-55
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 15 mg/1Capsule, Delayed releaseOralMacleods Pharmaceuticals Limited33342-31033342-0310-07
LansoprazoleLansoprazole 30 mg/1Capsule, Delayed releaseOralMacleods Pharmaceuticals Limited33342-31133342-0311-07
LansoprazoleLansoprazole 15 mg/1Tablet, Orally disintegrating, Delayed releaseOralAurobindo Pharma Limited65862-89565862-0895-78
LansoprazoleLansoprazole 30 mg/1Tablet, Orally disintegrating, Delayed releaseOralAurobindo Pharma Limited65862-89665862-0896-78

All 95 Lansoprazole NDCs

Other NDCs under ANDA 203203

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

FDA NDC Directory listings under ANDA 203203
ProductStrengthForm · routeLabelerProduct NDC
LansoprazoleLansoprazole 30 mg/1Capsule, Delayed releaseOralA-S Medication Solutions50090-6154
LansoprazoleLansoprazole 30 mg/1Capsule, Delayed releaseOralA-S Medication Solutions50090-7651
LansoprazoleLansoprazole 30 mg/1Capsule, Delayed releaseOralGolden State Medical Supply, Inc.51407-324
LansoprazoleLansoprazole 30 mg/1Capsule, Delayed releaseOralBryant Ranch Prepack63629-2340
LansoprazoleLansoprazole 30 mg/1Capsule, Delayed releaseOralBryant Ranch Prepack63629-2341
LansoprazoleLansoprazole 30 mg/1Capsule, Delayed releaseOralBryant Ranch Prepack63629-2342
LansoprazoleLansoprazole 30 mg/1Capsule, Delayed releaseOralNuCare Pharmaceuticals,Inc.68071-3572
LansoprazoleLansoprazole 30 mg/1Capsule, Delayed releaseOralNuCare Pharmaceuticals,Inc.68071-3870
LansoprazoleLansoprazole 15 mg/1Capsule, Delayed releaseOralXiromed LLC70700-262
LansoprazoleLansoprazole 30 mg/1Capsule, Delayed releaseOralXiromed LLC70700-263
LansoprazoleLansoprazole 30 mg/1Capsule, Delayed releaseOralBryant Ranch Prepack71335-1820
LansoprazoleLansoprazole 30 mg/1Capsule, Delayed releaseOralBryant Ranch Prepack72162-1976

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