FDA.reportPublic FDA data

Lansoprazole

Product NDC
68788-7742
11-digit product format
687887742
Labeler code
68788
Product ID
68788-7742_e4bb76ca-2202-43b5-be9a-3767ef0df6d0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lansoprazole
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
Preferred Pharmaceuticals, Inc.
Application
ANDA205868
Marketing category
ANDA
Marketing start
2020-07-01
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
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
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
68788-7742-1Lansoprazole14 in 1 BOTTLECAPSULE, DELAYED RELEASE147
68788-7742-3Lansoprazole30 in 1 BOTTLECAPSULE, DELAYED RELEASE307
68788-7742-6Lansoprazole60 in 1 BOTTLECAPSULE, DELAYED RELEASE607
68788-7742-8Lansoprazole120 in 1 BOTTLECAPSULE, DELAYED RELEASE1207
68788-7742-9Lansoprazole90 in 1 BOTTLECAPSULE, DELAYED RELEASE907

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-7742-1EA - Each68788-7742ce0113da-b510-4ce6-8212-94f0d3d9c3f212020-09-14
68788-7742-3EA - Each68788-774266b2bdb9-4072-4962-8262-800f5dc21fa412020-09-14
68788-7742-6EA - Each68788-7742de8c2083-dba2-498f-9085-12d386f4d13e12020-09-14
68788-7742-8EA - Each68788-77422ed3f4f3-b829-4cc9-8a2e-60ce6d8b88c312020-09-14
68788-7742-9EA - Each68788-774229e54fb8-a027-4f28-a754-ec20ed04fbaf12020-09-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-7742LANSOPRAZOLE CAPSULE, DELAYED RELEASE [PREFERRED PHARMACEUTICALS, INC.]5Current NDC, Legacy NDC, 5 package rows20240608_7286d6a5-611b-4993-ab93-4899d599435d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311277lansoprazole 30 MG Delayed Release Oral CapsulePSN7286d6a5-611b-4993-ab93-4899d599435d7
311277lansoprazole 30 MG Delayed Release Oral CapsuleSCD7286d6a5-611b-4993-ab93-4899d599435d7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68788-7742-16878877420114 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68788-7742-1) 2020-07-010000-00-00NoNoCurrent
68788-7742-36878877420330 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68788-7742-3) 2020-07-010000-00-00NoNoCurrent
68788-7742-66878877420660 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68788-7742-6) 2020-07-010000-00-00NoNoCurrent
68788-7742-868788774208120 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68788-7742-8) 2020-07-010000-00-00NoNoCurrent
68788-7742-96878877420990 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68788-7742-9) 2020-07-010000-00-00NoNoCurrent