FDA.reportPublic FDA data

Lansoprazole

Product NDC
27241-019
11-digit product format
272410019
Labeler code
27241
Product ID
27241-019_1e0a31f6-b245-43a0-81f4-8654c4b381d2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lansoprazole
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
Ajanta Pharma USA Inc.
Application
ANDA203957
Marketing category
ANDA
Marketing start
2016-10-18
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
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
d6b97638-59f4-48e2-8959-569628732c46Product name920210622
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
8690a824-4bf8-4d1e-b118-2d6dda86bc04Product name220161206
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
27241-019-03Lansoprazole30 in 1 BOTTLECAPSULE, DELAYED RELEASE3017
27241-019-10Lansoprazole100 in 1 BOTTLECAPSULE, DELAYED RELEASE10017

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
27241-019-03EA - Each27241-019e1d0fc93-3f1d-4e7b-8955-b64d90c446df12017-06-15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
27241-019LANSOPRAZOLE CAPSULE, DELAYED RELEASE [AJANTA PHARMA USA INC.]16Current NDC, Legacy NDC, 2 package rows20250418_6b9c60e9-b0d2-4aec-a04b-ccc7a62c822b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
596843lansoprazole 15 MG Delayed Release Oral CapsulePSN6b9c60e9-b0d2-4aec-a04b-ccc7a62c822b17
311277lansoprazole 30 MG Delayed Release Oral CapsulePSN6b9c60e9-b0d2-4aec-a04b-ccc7a62c822b17
596843lansoprazole 15 MG Delayed Release Oral CapsuleSCD6b9c60e9-b0d2-4aec-a04b-ccc7a62c822b17
311277lansoprazole 30 MG Delayed Release Oral CapsuleSCD6b9c60e9-b0d2-4aec-a04b-ccc7a62c822b17

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
27241-019-032724100190330 CAPSULE, DELAYED RELEASE in 1 BOTTLE (27241-019-03) 2016-10-180000-00-00NoNoCurrent
27241-019-1027241001910100 CAPSULE, DELAYED RELEASE in 1 BOTTLE (27241-019-10) 2016-10-180000-00-00NoNoCurrent