FDA.reportPublic FDA data

Lansoprazole

Product NDC
21130-019
11-digit product format
211300019
Labeler code
21130
Product ID
21130-019_ef523ae9-f41b-4faf-8a6f-6cd4538e6be1
Type
HUMAN OTC DRUG
Nonproprietary name
Lansoprazole
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
Safeway, Inc.
Application
ANDA202727
Marketing category
ANDA
Marketing start
2012-12-31
Marketing end
0000-00-00
Substance
LANSOPRAZOLE
Active strength
15 mg/1
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

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
21130-019-142019-11-27C16284748780-19855e2a2-3f30-60a7-e053-dbdaa90a05bdDrug Facts
21130-019-282019-11-27C16284748780-19855e2a2-3f30-60a7-e053-dbdaa90a05bdDrug Facts
21130-019-422019-11-27C16284748780-19855e2a2-3f30-60a7-e053-dbdaa90a05bdDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21130-019-14Lansoprazole14 in 1 BOTTLECAPSULE, DELAYED RELEASE142
21130-019-14Lansoprazole1 in 1 BOXCAPSULE, DELAYED RELEASE12
21130-019-28Lansoprazole14 in 1 BOTTLECAPSULE, DELAYED RELEASE142
21130-019-28Lansoprazole2 in 1 BOXCAPSULE, DELAYED RELEASE22
21130-019-42Lansoprazole14 in 1 BOTTLECAPSULE, DELAYED RELEASE142
21130-019-42Lansoprazole3 in 1 BOXCAPSULE, DELAYED RELEASE32

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LANSOPRAZOLEACTIVE INGREDIENT0K5C5T2QPGLANSOPRAZOLE CAPSULE, DELAYED RELEASE [SAFEWAY, INC.]2
LANSOPRAZOLEACTIVE MOIETY0K5C5T2QPGLANSOPRAZOLE CAPSULE, DELAYED RELEASE [SAFEWAY, INC.]2
D&C RED NO. 33INACTIVE INGREDIENT9DBA0SBB0LLANSOPRAZOLE CAPSULE, DELAYED RELEASE [SAFEWAY, INC.]2
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GLANSOPRAZOLE CAPSULE, DELAYED RELEASE [SAFEWAY, INC.]2
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDLANSOPRAZOLE CAPSULE, DELAYED RELEASE [SAFEWAY, INC.]2
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOALANSOPRAZOLE CAPSULE, DELAYED RELEASE [SAFEWAY, INC.]2
GELATININACTIVE INGREDIENT2G86QN327LLANSOPRAZOLE CAPSULE, DELAYED RELEASE [SAFEWAY, INC.]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOLANSOPRAZOLE CAPSULE, DELAYED RELEASE [SAFEWAY, INC.]2
MAGNESIUM CARBONATEINACTIVE INGREDIENT0E53J927NALANSOPRAZOLE CAPSULE, DELAYED RELEASE [SAFEWAY, INC.]2
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)INACTIVE INGREDIENT74G4R6TH13LANSOPRAZOLE CAPSULE, DELAYED RELEASE [SAFEWAY, INC.]2
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ALANSOPRAZOLE CAPSULE, DELAYED RELEASE [SAFEWAY, INC.]2
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HLANSOPRAZOLE CAPSULE, DELAYED RELEASE [SAFEWAY, INC.]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4LANSOPRAZOLE CAPSULE, DELAYED RELEASE [SAFEWAY, INC.]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJLANSOPRAZOLE CAPSULE, DELAYED RELEASE [SAFEWAY, INC.]2
SUCROSEINACTIVE INGREDIENTC151H8M554LANSOPRAZOLE CAPSULE, DELAYED RELEASE [SAFEWAY, INC.]2
TALCINACTIVE INGREDIENT7SEV7J4R1ULANSOPRAZOLE CAPSULE, DELAYED RELEASE [SAFEWAY, INC.]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPLANSOPRAZOLE CAPSULE, DELAYED RELEASE [SAFEWAY, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21130-019LANSOPRAZOLE CAPSULE, DELAYED RELEASE [SAFEWAY, INC.]2Legacy NDC, 6 package rows20131220_5cd41b0a-190d-4460-a536-aa401dc0abb4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
596843lansoprazole 15 MG Delayed Release Oral CapsulePSN5cd41b0a-190d-4460-a536-aa401dc0abb42
596843lansoprazole 15 MG Delayed Release Oral CapsuleSCD5cd41b0a-190d-4460-a536-aa401dc0abb42

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
21130-019-142113000191414 in 1 BOTTLEHistorical
21130-019-282113000192814 in 1 BOTTLEHistorical
21130-019-422113000194214 in 1 BOTTLEHistorical