FDA.reportPublic FDA data

Lansoprazole

Product NDC
0378-8015
11-digit product format
003788015
Labeler code
0378
Product ID
0378-8015_810def72-c1da-4c4d-9939-32b29be79e0c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
lansoprazole
Dosage form
CAPSULE, DELAYED RELEASE PELLETS
Route
ORAL
Labeler
Mylan Pharmaceuticals Inc.
Application
ANDA090763
Marketing category
ANDA
Marketing start
2009-11-10
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
Rxcui311277, 596843

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
0378-8015-93Lansoprazole30 in 1 BOTTLE, PLASTICCAPSULE, DELAYED RELEASE PELLETS3022

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0378-8015-10EA - Each0378-80157f9d74d1-b7ff-4251-bf49-10b78b60e34712012-07-24
0378-8015-93EA - Each0378-80157c80334e-4b40-4672-af1b-9c2a238f84e312012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LANSOPRAZOLEACTIVE INGREDIENT0K5C5T2QPGLANSOPRAZOLE CAPSULE, DELAYED RELEASE PELLETS [MYLAN PHARMACEUTICALS INC.]11
LANSOPRAZOLEACTIVE MOIETY0K5C5T2QPGLANSOPRAZOLE CAPSULE, DELAYED RELEASE PELLETS [MYLAN PHARMACEUTICALS INC.]11
AMMONIAINACTIVE INGREDIENT5138Q19F1XLANSOPRAZOLE CAPSULE, DELAYED RELEASE PELLETS [MYLAN PHARMACEUTICALS INC.]11
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDLANSOPRAZOLE CAPSULE, DELAYED RELEASE PELLETS [MYLAN PHARMACEUTICALS INC.]11
FD&C GREEN NO. 3INACTIVE INGREDIENT3P3ONR6O1SLANSOPRAZOLE CAPSULE, DELAYED RELEASE PELLETS [MYLAN PHARMACEUTICALS INC.]11
FD&C RED NO. 3INACTIVE INGREDIENTPN2ZH5LOQYLANSOPRAZOLE CAPSULE, DELAYED RELEASE PELLETS [MYLAN PHARMACEUTICALS INC.]11
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOALANSOPRAZOLE CAPSULE, DELAYED RELEASE PELLETS [MYLAN PHARMACEUTICALS INC.]11
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357LANSOPRAZOLE CAPSULE, DELAYED RELEASE PELLETS [MYLAN PHARMACEUTICALS INC.]11
GELATININACTIVE INGREDIENT2G86QN327LLANSOPRAZOLE CAPSULE, DELAYED RELEASE PELLETS [MYLAN PHARMACEUTICALS INC.]11
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PLANSOPRAZOLE CAPSULE, DELAYED RELEASE PELLETS [MYLAN PHARMACEUTICALS INC.]11
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTEDINACTIVE INGREDIENT2165RE0K14LANSOPRAZOLE CAPSULE, DELAYED RELEASE PELLETS [MYLAN PHARMACEUTICALS INC.]11
MAGNESIUM CARBONATEINACTIVE INGREDIENT0E53J927NALANSOPRAZOLE CAPSULE, DELAYED RELEASE PELLETS [MYLAN PHARMACEUTICALS INC.]11
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AINACTIVE INGREDIENTNX76LV5T8JLANSOPRAZOLE CAPSULE, DELAYED RELEASE PELLETS [MYLAN PHARMACEUTICALS INC.]11
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ALANSOPRAZOLE CAPSULE, DELAYED RELEASE PELLETS [MYLAN PHARMACEUTICALS INC.]11
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HLANSOPRAZOLE CAPSULE, DELAYED RELEASE PELLETS [MYLAN PHARMACEUTICALS INC.]11
POTASSIUM HYDROXIDEINACTIVE INGREDIENTWZH3C48M4TLANSOPRAZOLE CAPSULE, DELAYED RELEASE PELLETS [MYLAN PHARMACEUTICALS INC.]11
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3LANSOPRAZOLE CAPSULE, DELAYED RELEASE PELLETS [MYLAN PHARMACEUTICALS INC.]11
SHELLACINACTIVE INGREDIENT46N107B71OLANSOPRAZOLE CAPSULE, DELAYED RELEASE PELLETS [MYLAN PHARMACEUTICALS INC.]11
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4LANSOPRAZOLE CAPSULE, DELAYED RELEASE PELLETS [MYLAN PHARMACEUTICALS INC.]11
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJLANSOPRAZOLE CAPSULE, DELAYED RELEASE PELLETS [MYLAN PHARMACEUTICALS INC.]11
SUCROSEINACTIVE INGREDIENTC151H8M554LANSOPRAZOLE CAPSULE, DELAYED RELEASE PELLETS [MYLAN PHARMACEUTICALS INC.]11
TALCINACTIVE INGREDIENT7SEV7J4R1ULANSOPRAZOLE CAPSULE, DELAYED RELEASE PELLETS [MYLAN PHARMACEUTICALS INC.]11
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPLANSOPRAZOLE CAPSULE, DELAYED RELEASE PELLETS [MYLAN PHARMACEUTICALS INC.]11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0378-8015LANSOPRAZOLE CAPSULE, DELAYED RELEASE PELLETS [MYLAN PHARMACEUTICALS INC.]22Current NDC, Legacy NDC, 1 package rows20241004_c8fa7401-907f-41b6-a2e1-f4bc214f2cdf.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
596843lansoprazole 15 MG Delayed Release Oral CapsulePSNc8fa7401-907f-41b6-a2e1-f4bc214f2cdf22
311277lansoprazole 30 MG Delayed Release Oral CapsulePSNc8fa7401-907f-41b6-a2e1-f4bc214f2cdf22
596843lansoprazole 15 MG Delayed Release Oral CapsuleSCDc8fa7401-907f-41b6-a2e1-f4bc214f2cdf22
311277lansoprazole 30 MG Delayed Release Oral CapsuleSCDc8fa7401-907f-41b6-a2e1-f4bc214f2cdf22

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0378-8015-930037880159330 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE, PLASTIC (0378-8015-93) 2009-11-100000-00-00NoNoCurrent