FDA.reportPublic FDA data

Lansoprazole

Product NDC
0093-3009
11-digit product format
000933009
Labeler code
0093
Product ID
0093-3009_eaa2693b-b9df-4cf3-b212-5de87110aa89
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lansoprazole
Dosage form
TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE
Route
ORAL
Labeler
Teva Pharmaceuticals USA, Inc.
Application
ANDA208784
Marketing category
ANDA
Marketing start
2018-03-08
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
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LANSOPRAZOLE30 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii0K5C5T2QPG
Rxcui351260, 351261

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
0093-3009-19Lansoprazole1 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING, D114
0093-3009-93Lansoprazole100 in 1 CARTONTABLET, ORALLY DISINTEGRATING, D10014

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0093-3009-19EA - Each0093-3009ac03accc-6972-4f2b-86c1-be0f7fbfce9712018-04-19
0093-3009-93EA - Each0093-3009c9924792-298d-4982-9a79-6b64dd4537c012018-04-19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0093-3009LANSOPRAZOLE TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE [TEVA PHARMACEUTICALS USA, INC.]14Current NDC, Legacy NDC, 2 package rows20220702_6b8dd0e1-cd69-4f9a-887f-e42627b5d78e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
351261lansoprazole 15 MG Delayed Release Disintegrating Oral TabletPSN6b8dd0e1-cd69-4f9a-887f-e42627b5d78e14
351260lansoprazole 30 MG Delayed Release Disintegrating Oral TabletPSN6b8dd0e1-cd69-4f9a-887f-e42627b5d78e14
351261lansoprazole 15 MG Disintegrating Oral TabletSCD6b8dd0e1-cd69-4f9a-887f-e42627b5d78e14
351260lansoprazole 30 MG Disintegrating Oral TabletSCD6b8dd0e1-cd69-4f9a-887f-e42627b5d78e14
351261lansoprazole 15 MG Delayed Release Disintegrating Oral TabletSY6b8dd0e1-cd69-4f9a-887f-e42627b5d78e14
351260lansoprazole 30 MG Delayed Release Disintegrating Oral TabletSY6b8dd0e1-cd69-4f9a-887f-e42627b5d78e14
351260lansoprazole 30 MG Delayed Release Disintegrating Oral TabletPSNc9a43df0-efab-4486-860f-92afdb258c8b5
351260lansoprazole 30 MG Disintegrating Oral TabletSCDc9a43df0-efab-4486-860f-92afdb258c8b5
351260lansoprazole 30 MG Delayed Release Disintegrating Oral TabletSYc9a43df0-efab-4486-860f-92afdb258c8b5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0093-3009-19000933009191 in 1 BLISTER PACKHistorical
0093-3009-9300093300993100 BLISTER PACK in 1 CARTON (0093-3009-93) / 1 TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE in 1 BLISTER PACK (0093-3009-19) 100 blister pack2018-03-080000-00-00NoNoCurrent