Lansoprazole

Product NDC
0378-8030
11-digit product format
003788030
Labeler code
0378
Product ID
0378-8030_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
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, 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
0378-8030-05Lansoprazole500 in 1 BOTTLE, PLASTICCAPSULE, DELAYED RELEASE PELLETS50022
0378-8030-77Lansoprazole90 in 1 BOTTLE, PLASTICCAPSULE, DELAYED RELEASE PELLETS9022
0378-8030-93Lansoprazole30 in 1 BOTTLE, PLASTICCAPSULE, DELAYED RELEASE PELLETS3022

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0378-8030LANSOPRAZOLE CAPSULE, DELAYED RELEASE PELLETS [MYLAN PHARMACEUTICALS INC.]22Current NDC, Legacy NDC, 3 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
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 formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0378-8030-0500378803005500 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE, PLASTIC (0378-8030-05) 2009-11-100000-00-00NoNoCurrent
0378-8030-770037880307790 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE, PLASTIC (0378-8030-77) 2009-11-100000-00-00NoNoCurrent
0378-8030-930037880309330 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE, PLASTIC (0378-8030-93) 2009-11-100000-00-00NoNoCurrent