FDA.reportPublic FDA data

Lansoprazole

Product NDC
11822-3374
11-digit product format
118223374
Labeler code
11822
Product ID
11822-3374_a4c3b92d-38c5-4375-a950-42bf3af2482d
Type
HUMAN OTC DRUG
Nonproprietary name
Lansoprazole
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
Rite Aid Corporation
Application
ANDA203187
Marketing category
ANDA
Marketing start
2019-11-29
Marketing end
2026-11-29
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
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Lansoprazole

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
11822-3374-52025-08-25C16284748780-12cef2736-644f-d83d-e063-dadaa90ab31fDRUG FACTS
11822-3374-72025-08-25C16284748780-12cef2736-644f-d83d-e063-dadaa90ab31fDRUG FACTS
11822-3374-52025-01-30C16284748780-12cef2736-644f-d83d-e063-dadaa90ab31fDRUG FACTS
11822-3374-72025-01-30C16284748780-12cef2736-644f-d83d-e063-dadaa90ab31fDRUG FACTS

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11822-3374-5Lansoprazole14 in 1 BOTTLECAPSULE, DELAYED RELEASE144
11822-3374-5Lansoprazole1 in 1 CARTONCAPSULE, DELAYED RELEASE14
11822-3374-7Lansoprazole3 in 1 BOXCAPSULE, DELAYED RELEASE34
11822-3374-7Lansoprazole14 in 1 BOTTLE, PLASTICCAPSULE, DELAYED RELEASE144

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11822-3374LANSOPRAZOLE CAPSULE, DELAYED RELEASE [RITE AID CORPORATION]3Current NDC, Legacy NDC, 4 package rows20220513_5f256a0c-14df-4fd9-a818-b4276954152e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
596843lansoprazole 15 MG Delayed Release Oral CapsulePSN5f256a0c-14df-4fd9-a818-b4276954152e4
596843lansoprazole 15 MG Delayed Release Oral CapsuleSCD5f256a0c-14df-4fd9-a818-b4276954152e4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
11822-3374-5118223374051 BOTTLE in 1 CARTON (11822-3374-5) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE1 bottle2019-11-292026-11-29NoNoCurrent
11822-3374-7118223374073 BOTTLE, PLASTIC in 1 BOX (11822-3374-7) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC2019-11-292026-11-29NoNoCurrent