FDA.reportPublic FDA data

Lansoprazole

Product NDC
65862-895
11-digit product format
658620895
Labeler code
65862
Product ID
65862-895_b6e087dc-5328-4c55-8efb-a683667bf11d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lansoprazole
Dosage form
TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE
Route
ORAL
Labeler
Aurobindo Pharma Limited
Application
ANDA207167
Marketing category
ANDA
Marketing start
2023-03-28
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
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
LANSOPRAZOLE15 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii0K5C5T2QPG
Rxcui351260, 351261

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
d6b97638-59f4-48e2-8959-569628732c46Product name920210622
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
8690a824-4bf8-4d1e-b118-2d6dda86bc04Product name220161206
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65862-895-10Lansoprazole10 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING, D102
65862-895-78Lansoprazole10 in 1 CARTONTABLET, ORALLY DISINTEGRATING, D102

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65862-895-10EA - Each65862-895a5e2267a-adc6-43c3-b969-f3d407751a4212025-05-14
65862-895-78EA - Each65862-895c4d19e2c-f1c4-43bc-bd9e-5bd6022fda8312023-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65862-895LANSOPRAZOLE TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE [AUROBINDO PHARMA LIMITED]2Current NDC, 2 package rows20240421_1f2883d8-12db-40b7-9104-22a6690a22a7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
351261lansoprazole 15 MG Delayed Release Disintegrating Oral TabletPSN1f2883d8-12db-40b7-9104-22a6690a22a72
351260lansoprazole 30 MG Delayed Release Disintegrating Oral TabletPSN1f2883d8-12db-40b7-9104-22a6690a22a72
351261lansoprazole 15 MG Disintegrating Oral TabletSCD1f2883d8-12db-40b7-9104-22a6690a22a72
351260lansoprazole 30 MG Disintegrating Oral TabletSCD1f2883d8-12db-40b7-9104-22a6690a22a72
351261lansoprazole 15 MG Delayed Release Disintegrating Oral TabletSY1f2883d8-12db-40b7-9104-22a6690a22a72
351260lansoprazole 30 MG Delayed Release Disintegrating Oral TabletSY1f2883d8-12db-40b7-9104-22a6690a22a72

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
65862-895-106586208951010 in 1 BLISTER PACKHistorical
65862-895-786586208957810 BLISTER PACK in 1 CARTON (65862-895-78) / 10 TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE in 1 BLISTER PACK (65862-895-10) 10 blister pack2023-03-28NoNoHistorical