FDA.reportPublic FDA data

Lansoprazole

Product NDC
71335-1820
11-digit product format
713351820
Labeler code
71335
Product ID
71335-1820_e66cf5f3-d909-40ad-a03d-c0423f41aa23
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lansoprazole
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA203203
Marketing category
ANDA
Marketing start
2018-08-24
Substance
LANSOPRAZOLE
Active strength
30 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
LANSOPRAZOLE30 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii0K5C5T2QPG
Rxcui311277

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
71335-1820-1Lansoprazole30 in 1 BOTTLECAPSULE, DELAYED RELEASE30102
71335-1820-2Lansoprazole90 in 1 BOTTLECAPSULE, DELAYED RELEASE90102
71335-1820-3Lansoprazole18 in 1 BOTTLECAPSULE, DELAYED RELEASE18102
71335-1820-4Lansoprazole28 in 1 BOTTLECAPSULE, DELAYED RELEASE28102
71335-1820-5Lansoprazole56 in 1 BOTTLECAPSULE, DELAYED RELEASE56102
71335-1820-6Lansoprazole58 in 1 BOTTLECAPSULE, DELAYED RELEASE58102
71335-1820-7Lansoprazole60 in 1 BOTTLECAPSULE, DELAYED RELEASE60102
71335-1820-8Lansoprazole180 in 1 BOTTLECAPSULE, DELAYED RELEASE180102
71335-1820-9Lansoprazole120 in 1 BOTTLECAPSULE, DELAYED RELEASE120102

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-1820-1EA - Each71335-1820f3d2e160-4aad-4522-8048-292626b3f7f012025-03-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1820LANSOPRAZOLE CAPSULE, DELAYED RELEASE [BRYANT RANCH PREPACK]102Current NDC, Legacy NDC, 9 package rows20231115_a612a237-ec17-49f0-8985-44407608adb5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311277lansoprazole 30 MG Delayed Release Oral CapsulePSNa612a237-ec17-49f0-8985-44407608adb5102
311277lansoprazole 30 MG Delayed Release Oral CapsuleSCDa612a237-ec17-49f0-8985-44407608adb5102

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-1820-17133518200130 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-1820-1) 2021-05-050000-00-00NoNoCurrent
71335-1820-27133518200290 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-1820-2) 2021-05-210000-00-00NoNoCurrent
71335-1820-37133518200318 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-1820-3) 2022-07-060000-00-00NoNoCurrent
71335-1820-47133518200428 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-1820-4) 2022-07-060000-00-00NoNoCurrent
71335-1820-57133518200556 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-1820-5) 2022-07-060000-00-00NoNoCurrent
71335-1820-67133518200658 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-1820-6) 2022-07-060000-00-00NoNoCurrent
71335-1820-77133518200760 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-1820-7) 2022-07-060000-00-00NoNoCurrent
71335-1820-871335182008180 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-1820-8) 2022-07-060000-00-00NoNoCurrent
71335-1820-971335182009120 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-1820-9) 2022-07-060000-00-00NoNoCurrent