FDA.reportPublic FDA data

Lansoprazole

Product NDC
71335-1425
11-digit product format
713351425
Labeler code
71335
Product ID
71335-1425_40271c8f-06d7-42c1-a983-8d49f0205268
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lansoprazole
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA205868
Marketing category
ANDA
Marketing start
2018-06-04
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

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
71335-1425-1Lansoprazole30 in 1 BOTTLECAPSULE, DELAYED RELEASE306
71335-1425-2Lansoprazole90 in 1 BOTTLECAPSULE, DELAYED RELEASE906
71335-1425-3Lansoprazole18 in 1 BOTTLECAPSULE, DELAYED RELEASE186
71335-1425-4Lansoprazole28 in 1 BOTTLECAPSULE, DELAYED RELEASE286
71335-1425-5Lansoprazole56 in 1 BOTTLECAPSULE, DELAYED RELEASE566
71335-1425-6Lansoprazole58 in 1 BOTTLECAPSULE, DELAYED RELEASE586
71335-1425-7Lansoprazole60 in 1 BOTTLECAPSULE, DELAYED RELEASE606
71335-1425-8Lansoprazole180 in 1 BOTTLECAPSULE, DELAYED RELEASE1806
71335-1425-9Lansoprazole120 in 1 BOTTLECAPSULE, DELAYED RELEASE1206

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-1425-1EA - Each71335-14255e326d1f-1e45-463b-b572-704c3f94467612023-12-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1425LANSOPRAZOLE CAPSULE, DELAYED RELEASE [BRYANT RANCH PREPACK]6Current NDC, Legacy NDC, 9 package rows20240828_8f0d3f2f-91d9-467a-a841-540664af80f9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311277lansoprazole 30 MG Delayed Release Oral CapsulePSN8f0d3f2f-91d9-467a-a841-540664af80f96
311277lansoprazole 30 MG Delayed Release Oral CapsuleSCD8f0d3f2f-91d9-467a-a841-540664af80f96

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-1425-17133514250130 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-1425-1) 2019-12-040000-00-00NoNoCurrent
71335-1425-27133514250290 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-1425-2) 2020-11-060000-00-00NoNoCurrent
71335-1425-37133514250318 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-1425-3) 2022-05-020000-00-00NoNoCurrent
71335-1425-47133514250428 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-1425-4) 2022-05-020000-00-00NoNoCurrent
71335-1425-57133514250556 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-1425-5) 2022-05-020000-00-00NoNoCurrent
71335-1425-67133514250658 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-1425-6) 2022-05-020000-00-00NoNoCurrent
71335-1425-77133514250760 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-1425-7) 2020-09-290000-00-00NoNoCurrent
71335-1425-871335142508180 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-1425-8) 2022-05-020000-00-00NoNoCurrent
71335-1425-971335142509120 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-1425-9) 2022-05-020000-00-00NoNoCurrent