FDA.reportPublic FDA data

Lansoprazole DR

Product NDC
72189-370
11-digit product format
721890370
Labeler code
72189
Product ID
72189-370_201d8e02-32f5-a292-e063-6294a90af7bd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lansoprazole DR
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
Direct_Rx
Application
ANDA205868
Marketing category
ANDA
Marketing start
2022-08-08
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 DR
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
72189-370-30Lansoprazole DR30 in 1 BOTTLECAPSULE, DELAYED RELEASE304
72189-370-90Lansoprazole DR90 in 1 BOTTLECAPSULE, DELAYED RELEASE904

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72189-370-30EA - Each72189-37067b43886-c0be-4f06-a2f8-a4dfcfaf023412024-06-10
72189-370-90EA - Each72189-370e73c728b-d3de-4f4a-9909-4905a65711ef12022-09-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72189-370LANSOPRAZOLE DR CAPSULE, DELAYED RELEASE [DIRECT_RX]4Current NDC, Legacy NDC, 2 package rows20240821_e5bcfc5b-f5a9-3260-e053-2a95a90ab70e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311277lansoprazole 30 MG Delayed Release Oral CapsulePSNe5bcfc5b-f5a9-3260-e053-2a95a90ab70e4
311277lansoprazole 30 MG Delayed Release Oral CapsuleSCDe5bcfc5b-f5a9-3260-e053-2a95a90ab70e4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
72189-370-307218903703030 CAPSULE, DELAYED RELEASE in 1 BOTTLE (72189-370-30) 2022-08-08NoNoCurrent
72189-370-907218903709090 CAPSULE, DELAYED RELEASE in 1 BOTTLE (72189-370-90) 2022-08-080000-00-00NoNoCurrent