Prescription drug · ANDA

Lansoprazole NDC 71335-0058

Lansoprazole 15 mg/1 · Capsule, Delayed release · Oral · Bryant Ranch Prepack

NDC codes

FDA NDC Directory
Product NDC (as listed)71335-0058Labeler and product segments. Claims need a package NDC.
Product NDC at billing width71335-0058Add 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
71335-0058-1713350058017133500580130 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-0058-1)Marketed from Aug 2, 2018
71335-0058-2713350058027133500580290 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-0058-2)Marketed from Dec 11, 2020
71335-0058-3713350058037133500580360 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-0058-3)Marketed from Apr 11, 2018
71335-0058-4713350058047133500580458 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-0058-4)Marketed from Jun 28, 2022
71335-0058-5713350058057133500580528 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-0058-5)Marketed from Jun 28, 2022
71335-0058-6713350058067133500580614 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-0058-6)Marketed from Dec 10, 2019
71335-0058-77133500580771335005807120 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-0058-7)Marketed from Jun 28, 2022
71335-0058-87133500580871335005808180 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-0058-8)Marketed from Jun 28, 2022

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 — 15 mg/1
Dosage form
Capsule, Delayed release
Route
Oral
Labeler
Bryant Ranch PrepackNDC labeler code 71335
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 71335-0058_b565e019-9796-48dc-ab9e-6c939bd7c08cSPL ID b565e019-9796-48dc-ab9e-6c939bd7c08cSPL set ID e07c7445-9652-4833-8b17-45c0124c4e5dRxCUI 596843UNII 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

N471335005801 followed by a unit qualifier and the quantity

Package 71335-0058-01. 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 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 (…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 71335-0058

What is NDC 71335-0058?
71335-0058 is the product NDC for Lansoprazole, Lansoprazole 15 mg/1 capsule, delayed release, listed with the FDA by Bryant Ranch Prepack. It has 8 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?
Bryant Ranch Prepack, NDC labeler code 71335. 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 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 15 mg/1Capsule, Delayed releaseOralBluePoint Laboratories68001-111
LansoprazoleLansoprazole 30 mg/1Capsule, Delayed releaseOralBluePoint Laboratories68001-112

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