FDA.reportPublic FDA data

Lansoprazole

Product NDC
71335-9680
11-digit product format
713359680
Labeler code
71335
Product ID
71335-9680_5dccd775-9b0f-4802-818f-d4914d3d82d0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lansoprazole
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA203083
Marketing category
ANDA
Marketing start
2020-05-18
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
71335-9680-1Lansoprazole30 in 1 BOTTLECAPSULE, DELAYED RELEASE30100
71335-9680-2Lansoprazole15 in 1 BOTTLECAPSULE, DELAYED RELEASE15100
71335-9680-3Lansoprazole60 in 1 BOTTLECAPSULE, DELAYED RELEASE60100
71335-9680-4Lansoprazole90 in 1 BOTTLECAPSULE, DELAYED RELEASE90100
71335-9680-5Lansoprazole28 in 1 BOTTLECAPSULE, DELAYED RELEASE28100

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-9680LANSOPRAZOLE CAPSULE, DELAYED RELEASE [BRYANT RANCH PREPACK]100Current NDC, 5 package rows20230407_551ae468-1a2d-43d6-a2a8-4e5f26e0f982.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
596843lansoprazole 15 MG Delayed Release Oral CapsulePSN551ae468-1a2d-43d6-a2a8-4e5f26e0f982100
596843lansoprazole 15 MG Delayed Release Oral CapsuleSCD551ae468-1a2d-43d6-a2a8-4e5f26e0f982100

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
71335-9680-17133596800130 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-9680-1) 2023-04-06NoNoCurrent
71335-9680-27133596800215 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-9680-2) 2023-04-06NoNoCurrent
71335-9680-37133596800360 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-9680-3) 2023-04-06NoNoCurrent
71335-9680-47133596800490 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-9680-4) 2023-04-06NoNoCurrent
71335-9680-57133596800528 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-9680-5) 2023-04-06NoNoCurrent