NDC codes

FDA NDC Directory
Product NDC (as listed)68382-772Labeler and product segments. Claims need a package NDC.
Product NDC at billing width68382-0772Add 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
68382-772-77683820772776838207727710 BLISTER PACK in 1 CARTON (68382-772-77) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (68382-772-30)Marketed from Nov 30, 2018

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 — 30 mg/1
Dosage form
Tablet, Orally disintegrating
Route
Oral
Labeler
Zydus Pharmaceuticals USA Inc.NDC labeler code 68382
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 200816
Marketing start
Listing expires
Other FDA classes
Inhibition Gastric Acid Secretion (Physiologic effect)Proton Pump Inhibitors (Mechanism)
Identifiers
Product ID 68382-772_3de4f129-dc87-48e1-b934-b2a038df8cf7SPL ID 3de4f129-dc87-48e1-b934-b2a038df8cf7SPL set ID 9b3869ad-f2f7-4954-b75c-5c23b8951635RxCUI 351260, 351261UNII 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

N468382077277 followed by a unit qualifier and the quantity

Package 68382-0772-77. 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 orally disintegrating tablets are proton pump inhbitors (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 esophagi…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 68382-772

What is NDC 68382-772?
68382-772 is the product NDC for Lansoprazole, Lansoprazole 30 mg/1 tablet, orally disintegrating, listed with the FDA by Zydus Pharmaceuticals USA Inc.. 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?
Zydus Pharmaceuticals USA Inc., NDC labeler code 68382. 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 200816

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

FDA NDC Directory listings under ANDA 200816
ProductStrengthForm · routeLabelerProduct NDC
LansoprazoleLansoprazole 15 mg/1Tablet, Orally disintegratingOralZydus Pharmaceuticals USA Inc.68382-771
LansoprazoleLansoprazole 15 mg/1Tablet, Orally disintegratingOralZydus Lifesciences Limited70771-1132
LansoprazoleLansoprazole 30 mg/1Tablet, Orally disintegratingOralZydus Lifesciences Limited70771-1133

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