FDA.reportPublic FDA data

Lansoprazole

Product NDC
68788-6390
11-digit product format
687886390
Labeler code
68788
Product ID
68788-6390_0f526740-dba7-4ef4-8832-634aca7d65ad
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
lansoprazole
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA091269
Marketing category
ANDA
Marketing start
2016-05-20
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Lansoprazole
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LANSOPRAZOLE15 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii0K5C5T2QPG
Rxcui596843

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
68788-6390-1Lansoprazole100 in 1 BOTTLECAPSULE, DELAYED RELEASE1009
68788-6390-2Lansoprazole20 in 1 BOTTLECAPSULE, DELAYED RELEASE209
68788-6390-3Lansoprazole30 in 1 BOTTLECAPSULE, DELAYED RELEASE309
68788-6390-4Lansoprazole14 in 1 BOTTLECAPSULE, DELAYED RELEASE149
68788-6390-6Lansoprazole60 in 1 BOTTLECAPSULE, DELAYED RELEASE609
68788-6390-7Lansoprazole40 in 1 BOTTLECAPSULE, DELAYED RELEASE409
68788-6390-8Lansoprazole120 in 1 BOTTLECAPSULE, DELAYED RELEASE1209
68788-6390-9Lansoprazole90 in 1 BOTTLECAPSULE, DELAYED RELEASE909

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-6390-6EA - Each68788-6390eb00d806-c335-4793-897d-0eafc7bf37fc12020-05-08
68788-6390-8EA - Each68788-6390ff8378b5-e070-4ceb-8731-36baaea97b1212020-05-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-6390LANSOPRAZOLE CAPSULE, DELAYED RELEASE [PREFERRED PHARMACEUTICALS INC.]8Current NDC, Legacy NDC, 8 package rows20240607_960d6601-aec5-4900-a400-385b6687a4bc.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
596843lansoprazole 15 MG Delayed Release Oral CapsulePSN960d6601-aec5-4900-a400-385b6687a4bc9
596843lansoprazole 15 MG Delayed Release Oral CapsuleSCD960d6601-aec5-4900-a400-385b6687a4bc9

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68788-6390-168788639001100 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68788-6390-1) 2016-05-200000-00-00NoNoCurrent
68788-6390-26878863900220 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68788-6390-2) 2016-05-200000-00-00NoNoCurrent
68788-6390-36878863900330 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68788-6390-3) 2016-05-200000-00-00NoNoCurrent
68788-6390-46878863900414 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68788-6390-4) 2016-05-200000-00-00NoNoCurrent
68788-6390-66878863900660 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68788-6390-6) 2016-05-200000-00-00NoNoCurrent
68788-6390-76878863900740 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68788-6390-7) 2017-06-210000-00-00NoNoCurrent
68788-6390-868788639008120 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68788-6390-8) 2016-05-200000-00-00NoNoCurrent
68788-6390-96878863900990 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68788-6390-9) 2016-05-200000-00-00NoNoCurrent