FDA.reportPublic FDA data

Lansoprazole

Product NDC
16714-185
11-digit product format
167140185
Labeler code
16714
Product ID
16714-185_1e12b24b-c259-7423-cf4a-494d2fbe098b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
lansoprazole
Dosage form
TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE
Route
ORAL
Labeler
NorthStar Rx LLC
Application
ANDA210465
Marketing category
ANDA
Marketing start
2021-12-10
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
d6b97638-59f4-48e2-8959-569628732c46Product name920210622
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
8690a824-4bf8-4d1e-b118-2d6dda86bc04Product name220161206
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
16714-185-01Lansoprazole10 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING, D103
16714-185-02Lansoprazole100 in 1 CARTONTABLET, ORALLY DISINTEGRATING, D1003

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16714-185-01EA - Each16714-185c175306b-ee64-4f09-b7c2-0b4e16f8baad12022-03-09
16714-185-02EA - Each16714-185261abb12-9820-4039-937c-1390e1693fe312022-03-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16714-185LANSOPRAZOLE TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE [NORTHSTAR RX LLC]3Current NDC, Legacy NDC, 2 package rows20231020_4c7cc078-09de-f4fc-d111-1248f2261d17.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
351261lansoprazole 15 MG Delayed Release Disintegrating Oral TabletPSN4c7cc078-09de-f4fc-d111-1248f2261d173
351260lansoprazole 30 MG Delayed Release Disintegrating Oral TabletPSN4c7cc078-09de-f4fc-d111-1248f2261d173
351261lansoprazole 15 MG Disintegrating Oral TabletSCD4c7cc078-09de-f4fc-d111-1248f2261d173
351260lansoprazole 30 MG Disintegrating Oral TabletSCD4c7cc078-09de-f4fc-d111-1248f2261d173
351261lansoprazole 15 MG Delayed Release Disintegrating Oral TabletSY4c7cc078-09de-f4fc-d111-1248f2261d173
351260lansoprazole 30 MG Delayed Release Disintegrating Oral TabletSY4c7cc078-09de-f4fc-d111-1248f2261d173

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
16714-185-011671401850110 in 1 BLISTER PACKHistorical
16714-185-0216714018502100 BLISTER PACK in 1 CARTON (16714-185-02) / 10 TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE in 1 BLISTER PACK (16714-185-01) 100 blister pack2021-12-100000-00-00NoNoCurrent