FDA.reportPublic FDA data

Lansoprazole

Product NDC
51079-121
11-digit product format
510790121
Labeler code
51079
Product ID
51079-121_4358ce86-d59d-4864-e063-6394a90a39a5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
lansoprazole
Dosage form
CAPSULE, DELAYED RELEASE PELLETS
Route
ORAL
Labeler
Mylan Institutional Inc.
Application
ANDA090763
Marketing category
ANDA
Marketing start
2009-12-01
Substance
LANSOPRAZOLE
Active strength
30 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
LANSOPRAZOLE30 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii0K5C5T2QPG
Rxcui311277

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
51079-121-01Lansoprazole1 in 1 BLISTER PACKCAPSULE, DELAYED RELEASE PELLETS118
51079-121-08Lansoprazole80 in 1 CARTONCAPSULE, DELAYED RELEASE PELLETS8018

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51079-121-01EA - Each51079-1211b6149bf-c5dd-43c5-8658-16be337d134212012-07-24
51079-121-08EA - Each51079-12167288d8e-155f-488e-ac60-be5928deeb3e12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LANSOPRAZOLEACTIVE INGREDIENT0K5C5T2QPGLANSOPRAZOLE CAPSULE, DELAYED RELEASE PELLETS [MYLAN INSTITUTIONAL INC.]5
LANSOPRAZOLEACTIVE MOIETY0K5C5T2QPGLANSOPRAZOLE CAPSULE, DELAYED RELEASE PELLETS [MYLAN INSTITUTIONAL INC.]5
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDLANSOPRAZOLE CAPSULE, DELAYED RELEASE PELLETS [MYLAN INSTITUTIONAL INC.]5
FD&C RED NO. 3INACTIVE INGREDIENTPN2ZH5LOQYLANSOPRAZOLE CAPSULE, DELAYED RELEASE PELLETS [MYLAN INSTITUTIONAL INC.]5
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357LANSOPRAZOLE CAPSULE, DELAYED RELEASE PELLETS [MYLAN INSTITUTIONAL INC.]5
GELATININACTIVE INGREDIENT2G86QN327LLANSOPRAZOLE CAPSULE, DELAYED RELEASE PELLETS [MYLAN INSTITUTIONAL INC.]5
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PLANSOPRAZOLE CAPSULE, DELAYED RELEASE PELLETS [MYLAN INSTITUTIONAL INC.]5
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTEDINACTIVE INGREDIENT2165RE0K14LANSOPRAZOLE CAPSULE, DELAYED RELEASE PELLETS [MYLAN INSTITUTIONAL INC.]5
MAGNESIUM CARBONATEINACTIVE INGREDIENT0E53J927NALANSOPRAZOLE CAPSULE, DELAYED RELEASE PELLETS [MYLAN INSTITUTIONAL INC.]5
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AINACTIVE INGREDIENTNX76LV5T8JLANSOPRAZOLE CAPSULE, DELAYED RELEASE PELLETS [MYLAN INSTITUTIONAL INC.]5
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ALANSOPRAZOLE CAPSULE, DELAYED RELEASE PELLETS [MYLAN INSTITUTIONAL INC.]5
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HLANSOPRAZOLE CAPSULE, DELAYED RELEASE PELLETS [MYLAN INSTITUTIONAL INC.]5
POTASSIUM HYDROXIDEINACTIVE INGREDIENTWZH3C48M4TLANSOPRAZOLE CAPSULE, DELAYED RELEASE PELLETS [MYLAN INSTITUTIONAL INC.]5
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3LANSOPRAZOLE CAPSULE, DELAYED RELEASE PELLETS [MYLAN INSTITUTIONAL INC.]5
SHELLACINACTIVE INGREDIENT46N107B71OLANSOPRAZOLE CAPSULE, DELAYED RELEASE PELLETS [MYLAN INSTITUTIONAL INC.]5
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4LANSOPRAZOLE CAPSULE, DELAYED RELEASE PELLETS [MYLAN INSTITUTIONAL INC.]5
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJLANSOPRAZOLE CAPSULE, DELAYED RELEASE PELLETS [MYLAN INSTITUTIONAL INC.]5
SUCROSEINACTIVE INGREDIENTC151H8M554LANSOPRAZOLE CAPSULE, DELAYED RELEASE PELLETS [MYLAN INSTITUTIONAL INC.]5
TALCINACTIVE INGREDIENT7SEV7J4R1ULANSOPRAZOLE CAPSULE, DELAYED RELEASE PELLETS [MYLAN INSTITUTIONAL INC.]5
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPLANSOPRAZOLE CAPSULE, DELAYED RELEASE PELLETS [MYLAN INSTITUTIONAL INC.]5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51079-121LANSOPRAZOLE CAPSULE, DELAYED RELEASE PELLETS [MYLAN INSTITUTIONAL INC.]16Current NDC, Legacy NDC, 2 package rows20250403_eea82d0b-6600-4693-a2b8-596a55458f61.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311277lansoprazole 30 MG Delayed Release Oral CapsulePSNeea82d0b-6600-4693-a2b8-596a55458f6118
311277lansoprazole 30 MG Delayed Release Oral CapsuleSCDeea82d0b-6600-4693-a2b8-596a55458f6118

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51079-121-01510790121011 in 1 BLISTER PACKHistorical
51079-121-085107901210880 BLISTER PACK in 1 CARTON (51079-121-08) / 1 CAPSULE, DELAYED RELEASE PELLETS in 1 BLISTER PACK (51079-121-01) 80 blister pack2009-12-010000-00-00NoNoCurrent