Lansoprazole

Product NDC
83324-001
11-digit product format
833240001
Labeler code
83324
Product ID
83324-001_014e5a2a-2dfa-cd9a-3713-d7b59ce8f656
Type
HUMAN OTC DRUG
Nonproprietary name
Lansoprazole
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
Chain Drug Marketing Association
Application
ANDA202194
Marketing category
ANDA
Marketing start
2022-04-12
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
83324-001-14Lansoprazole1 in 1 CARTONCAPSULE, DELAYED RELEASE14
83324-001-14Lansoprazole14 in 1 BOTTLECAPSULE, DELAYED RELEASE144

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
83324-001-14EA - Each83324-001fcdd9329-3bd7-4c0a-9ae3-23f3768256f912025-12-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83324-001LANSOPRAZOLE CAPSULE, DELAYED RELEASE [CHAIN DRUG MARKETING ASSOCIATION]3Current NDC, 2 package rows20241203_74417c65-cccd-5a6a-0f96-0d8cb5a1592a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
596843lansoprazole 15 MG Delayed Release Oral CapsulePSN74417c65-cccd-5a6a-0f96-0d8cb5a1592a4
596843lansoprazole 15 MG Delayed Release Oral CapsuleSCD74417c65-cccd-5a6a-0f96-0d8cb5a1592a4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
83324-001-14833240001141 BOTTLE in 1 CARTON (83324-001-14) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE1 bottle2023-05-18NoNoHistorical