FDA.reportPublic FDA data

Lansoprazole

Product NDC
55648-140
11-digit product format
556480140
Labeler code
55648
Product ID
55648-140_f93c2a1e-e11b-4b97-a282-29d0dbb1b8c9
Type
HUMAN OTC DRUG
Nonproprietary name
Lansoprazole
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
Wockhardt Limited
Application
ANDA202727
Marketing category
ANDA
Marketing start
2012-05-18
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
55648-140-002019-11-13C16284748780-197449f38-cecf-f6ea-e053-dbdaa90aa703Lansoprazole Delayed-Release Capsules USP, 15 mg
55648-140-012019-11-13C16284748780-197449f38-cecf-f6ea-e053-dbdaa90aa703Lansoprazole Delayed-Release Capsules USP, 15 mg
55648-140-072019-11-13C16284748780-197449f38-cecf-f6ea-e053-dbdaa90aa703Lansoprazole Delayed-Release Capsules USP, 15 mg
55648-140-082019-11-13C16284748780-197449f38-cecf-f6ea-e053-dbdaa90aa703Lansoprazole Delayed-Release Capsules USP, 15 mg
55648-140-092019-11-13C16284748780-197449f38-cecf-f6ea-e053-dbdaa90aa703Lansoprazole Delayed-Release Capsules USP, 15 mg
55648-140-102019-11-13C16284748780-197449f38-cecf-f6ea-e053-dbdaa90aa703Lansoprazole Delayed-Release Capsules USP, 15 mg
55648-140-112019-11-13C16284748780-197449f38-cecf-f6ea-e053-dbdaa90aa703Lansoprazole Delayed-Release Capsules USP, 15 mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55648-140-00Lansoprazole4500 in 1 POUCHCAPSULE, DELAYED RELEASE45002
55648-140-01Lansoprazole14 in 1 BOTTLECAPSULE, DELAYED RELEASE142
55648-140-01Lansoprazole1 in 1 CARTONCAPSULE, DELAYED RELEASE12
55648-140-07Lansoprazole14 in 1 BLISTER PACKCAPSULE, DELAYED RELEASE142
55648-140-07Lansoprazole1 in 1 CARTONCAPSULE, DELAYED RELEASE12
55648-140-08Lansoprazole14 in 1 BOTTLECAPSULE, DELAYED RELEASE142
55648-140-08Lansoprazole2 in 1 CARTONCAPSULE, DELAYED RELEASE22
55648-140-09Lansoprazole14 in 1 BOTTLECAPSULE, DELAYED RELEASE142
55648-140-09Lansoprazole3 in 1 CARTONCAPSULE, DELAYED RELEASE32
55648-140-10Lansoprazole2 in 1 CARTONCAPSULE, DELAYED RELEASE22
55648-140-10Lansoprazole14 in 1 BLISTER PACKCAPSULE, DELAYED RELEASE142
55648-140-11Lansoprazole3 in 1 CARTONCAPSULE, DELAYED RELEASE32
55648-140-11Lansoprazole14 in 1 BLISTER PACKCAPSULE, DELAYED RELEASE142

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LANSOPRAZOLEACTIVE INGREDIENT0K5C5T2QPGLANSOPRAZOLE CAPSULE, DELAYED RELEASE [WOCKHARDT LIMITED]2
LANSOPRAZOLEACTIVE MOIETY0K5C5T2QPGLANSOPRAZOLE CAPSULE, DELAYED RELEASE [WOCKHARDT LIMITED]2
D&C RED NO. 33INACTIVE INGREDIENT9DBA0SBB0LLANSOPRAZOLE CAPSULE, DELAYED RELEASE [WOCKHARDT LIMITED]2
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GLANSOPRAZOLE CAPSULE, DELAYED RELEASE [WOCKHARDT LIMITED]2
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDLANSOPRAZOLE CAPSULE, DELAYED RELEASE [WOCKHARDT LIMITED]2
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOALANSOPRAZOLE CAPSULE, DELAYED RELEASE [WOCKHARDT LIMITED]2
GELATININACTIVE INGREDIENT2G86QN327LLANSOPRAZOLE CAPSULE, DELAYED RELEASE [WOCKHARDT LIMITED]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOLANSOPRAZOLE CAPSULE, DELAYED RELEASE [WOCKHARDT LIMITED]2
MAGNESIUM CARBONATEINACTIVE INGREDIENT0E53J927NALANSOPRAZOLE CAPSULE, DELAYED RELEASE [WOCKHARDT LIMITED]2
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)INACTIVE INGREDIENT74G4R6TH13LANSOPRAZOLE CAPSULE, DELAYED RELEASE [WOCKHARDT LIMITED]2
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ALANSOPRAZOLE CAPSULE, DELAYED RELEASE [WOCKHARDT LIMITED]2
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HLANSOPRAZOLE CAPSULE, DELAYED RELEASE [WOCKHARDT LIMITED]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4LANSOPRAZOLE CAPSULE, DELAYED RELEASE [WOCKHARDT LIMITED]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJLANSOPRAZOLE CAPSULE, DELAYED RELEASE [WOCKHARDT LIMITED]2
SUCROSEINACTIVE INGREDIENTC151H8M554LANSOPRAZOLE CAPSULE, DELAYED RELEASE [WOCKHARDT LIMITED]2
TALCINACTIVE INGREDIENT7SEV7J4R1ULANSOPRAZOLE CAPSULE, DELAYED RELEASE [WOCKHARDT LIMITED]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPLANSOPRAZOLE CAPSULE, DELAYED RELEASE [WOCKHARDT LIMITED]2
LANSOPRAZOLEACTIVE INGREDIENT0K5C5T2QPGHEARTBURN RELIEF 24 HOUR (LANSOPRAZOLE) CAPSULE, DELAYED RELEASE [OUR FAMILY (NASH FINCH COMPANY)]1
LANSOPRAZOLEACTIVE MOIETY0K5C5T2QPGHEARTBURN RELIEF 24 HOUR (LANSOPRAZOLE) CAPSULE, DELAYED RELEASE [OUR FAMILY (NASH FINCH COMPANY)]1
D&C RED NO. 33INACTIVE INGREDIENT9DBA0SBB0LHEARTBURN RELIEF 24 HOUR (LANSOPRAZOLE) CAPSULE, DELAYED RELEASE [OUR FAMILY (NASH FINCH COMPANY)]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GHEARTBURN RELIEF 24 HOUR (LANSOPRAZOLE) CAPSULE, DELAYED RELEASE [OUR FAMILY (NASH FINCH COMPANY)]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDHEARTBURN RELIEF 24 HOUR (LANSOPRAZOLE) CAPSULE, DELAYED RELEASE [OUR FAMILY (NASH FINCH COMPANY)]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAHEARTBURN RELIEF 24 HOUR (LANSOPRAZOLE) CAPSULE, DELAYED RELEASE [OUR FAMILY (NASH FINCH COMPANY)]1
GELATININACTIVE INGREDIENT2G86QN327LHEARTBURN RELIEF 24 HOUR (LANSOPRAZOLE) CAPSULE, DELAYED RELEASE [OUR FAMILY (NASH FINCH COMPANY)]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOHEARTBURN RELIEF 24 HOUR (LANSOPRAZOLE) CAPSULE, DELAYED RELEASE [OUR FAMILY (NASH FINCH COMPANY)]1
MAGNESIUM CARBONATEINACTIVE INGREDIENT0E53J927NAHEARTBURN RELIEF 24 HOUR (LANSOPRAZOLE) CAPSULE, DELAYED RELEASE [OUR FAMILY (NASH FINCH COMPANY)]1
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)INACTIVE INGREDIENT74G4R6TH13HEARTBURN RELIEF 24 HOUR (LANSOPRAZOLE) CAPSULE, DELAYED RELEASE [OUR FAMILY (NASH FINCH COMPANY)]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AHEARTBURN RELIEF 24 HOUR (LANSOPRAZOLE) CAPSULE, DELAYED RELEASE [OUR FAMILY (NASH FINCH COMPANY)]1
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HHEARTBURN RELIEF 24 HOUR (LANSOPRAZOLE) CAPSULE, DELAYED RELEASE [OUR FAMILY (NASH FINCH COMPANY)]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4HEARTBURN RELIEF 24 HOUR (LANSOPRAZOLE) CAPSULE, DELAYED RELEASE [OUR FAMILY (NASH FINCH COMPANY)]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJHEARTBURN RELIEF 24 HOUR (LANSOPRAZOLE) CAPSULE, DELAYED RELEASE [OUR FAMILY (NASH FINCH COMPANY)]1
SUCROSEINACTIVE INGREDIENTC151H8M554HEARTBURN RELIEF 24 HOUR (LANSOPRAZOLE) CAPSULE, DELAYED RELEASE [OUR FAMILY (NASH FINCH COMPANY)]1
TALCINACTIVE INGREDIENT7SEV7J4R1UHEARTBURN RELIEF 24 HOUR (LANSOPRAZOLE) CAPSULE, DELAYED RELEASE [OUR FAMILY (NASH FINCH COMPANY)]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPHEARTBURN RELIEF 24 HOUR (LANSOPRAZOLE) CAPSULE, DELAYED RELEASE [OUR FAMILY (NASH FINCH COMPANY)]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55648-140LANSOPRAZOLE CAPSULE, DELAYED RELEASE [WOCKHARDT LIMITED]2Legacy NDC, 13 package rows20120521_7b248d72-45ba-478a-8e10-caff5919490f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
596843lansoprazole 15 MG Delayed Release Oral CapsulePSN7b248d72-45ba-478a-8e10-caff5919490f2
596843lansoprazole 15 MG Delayed Release Oral CapsuleSCD7b248d72-45ba-478a-8e10-caff5919490f2
596843lansoprazole 15 MG Delayed Release Oral CapsulePSNff3d9fc7-4075-4d97-ade5-155ce818edae1
596843lansoprazole 15 MG Delayed Release Oral CapsuleSCDff3d9fc7-4075-4d97-ade5-155ce818edae1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
55648-140-00556480140004500 in 1 POUCHHistorical
55648-140-015564801400114 in 1 BOTTLEHistorical
55648-140-075564801400714 in 1 BLISTER PACKHistorical
55648-140-085564801400814 in 1 BOTTLEHistorical
55648-140-095564801400914 in 1 BOTTLEHistorical
55648-140-10556480140102 in 1 CARTONHistorical
55648-140-11556480140113 in 1 CARTONHistorical