FDA.reportPublic FDA data

Lansoprazole

Product NDC
71335-0058
11-digit product format
713350058
Labeler code
71335
Product ID
71335-0058_b565e019-9796-48dc-ab9e-6c939bd7c08c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
lansoprazole
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA091269
Marketing category
ANDA
Marketing start
2010-10-15
Substance
LANSOPRAZOLE
Active strength
15 mg/1
Pharmacologic classes
Inhibition Gastric Acid Secretion [PE], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Lansoprazole
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LANSOPRAZOLE15 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii0K5C5T2QPG
Rxcui596843

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d6b97638-59f4-48e2-8959-569628732c46Product name920210622
8690a824-4bf8-4d1e-b118-2d6dda86bc04Product name220161206

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-0058-1Lansoprazole30 in 1 BOTTLECAPSULE, DELAYED RELEASE3018
71335-0058-2Lansoprazole90 in 1 BOTTLECAPSULE, DELAYED RELEASE9018
71335-0058-3Lansoprazole60 in 1 BOTTLECAPSULE, DELAYED RELEASE6018
71335-0058-4Lansoprazole58 in 1 BOTTLECAPSULE, DELAYED RELEASE5818
71335-0058-5Lansoprazole28 in 1 BOTTLECAPSULE, DELAYED RELEASE2818
71335-0058-6Lansoprazole14 in 1 BOTTLECAPSULE, DELAYED RELEASE1418
71335-0058-7Lansoprazole120 in 1 BOTTLECAPSULE, DELAYED RELEASE12018
71335-0058-8Lansoprazole180 in 1 BOTTLECAPSULE, DELAYED RELEASE18018

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-0058-3EA - Each71335-005841f25b1e-279e-4e34-8510-0bf68dad54d112025-08-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-0058LANSOPRAZOLE CAPSULE, DELAYED RELEASE [BRYANT RANCH PREPACK]18Current NDC, Legacy NDC, 8 package rows20240821_e07c7445-9652-4833-8b17-45c0124c4e5d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
596843lansoprazole 15 MG Delayed Release Oral CapsulePSNe07c7445-9652-4833-8b17-45c0124c4e5d18
596843lansoprazole 15 MG Delayed Release Oral CapsuleSCDe07c7445-9652-4833-8b17-45c0124c4e5d18

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-0058-17133500580130 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-0058-1) 2018-08-020000-00-00NoNoCurrent
71335-0058-27133500580290 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-0058-2) 2020-12-110000-00-00NoNoCurrent
71335-0058-37133500580360 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-0058-3) 2018-04-110000-00-00NoNoCurrent
71335-0058-47133500580458 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-0058-4) 2022-06-280000-00-00NoNoCurrent
71335-0058-57133500580528 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-0058-5) 2022-06-280000-00-00NoNoCurrent
71335-0058-67133500580614 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-0058-6) 2019-12-100000-00-00NoNoCurrent
71335-0058-771335005807120 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-0058-7) 2022-06-280000-00-00NoNoCurrent
71335-0058-871335005808180 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-0058-8) 2022-06-280000-00-00NoNoCurrent