Prevacid 24 HR

Product NDC
0113-6117
11-digit product format
001136117
Labeler code
0113
Product ID
0113-6117_ba763965-9e51-42e4-9d4a-a53f0a6cbefc
Type
HUMAN OTC DRUG
Nonproprietary name
lansoprazole
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
L. Perrigo Company
Application
ANDA202319
Marketing category
ANDA
Marketing start
2023-03-30
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
Prevacid 24 HR
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LANSOPRAZOLE15 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii0K5C5T2QPG
Rxcui596843, 596918

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
0113-6117-01Prevacid 24 HR1 in 1 CARTONCAPSULE, DELAYED RELEASE13
0113-6117-01Prevacid 24 HR14 in 1 BOTTLECAPSULE, DELAYED RELEASE143
0113-6117-03Prevacid 24 HR14 in 1 BOTTLECAPSULE, DELAYED RELEASE143
0113-6117-03Prevacid 24 HR3 in 1 CARTONCAPSULE, DELAYED RELEASE33

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0113-6117-01EA - Each0113-611742874cf8-d2e0-49d9-80ef-c8480656f78012024-02-14
0113-6117-03EA - Each0113-611750eafea8-65bd-4d23-b994-c25214892efa12024-02-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0113-6117PREVACID 24 HR (LANSOPRAZOLE) CAPSULE, DELAYED RELEASE [L. PERRIGO COMPANY]2Current NDC, 4 package rows20240608_205c9c1e-b422-4e86-a4b0-714b608adc19.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
596843lansoprazole 15 MG Delayed Release Oral CapsulePSN205c9c1e-b422-4e86-a4b0-714b608adc193
596918Prevacid 15 MG Delayed Release Oral CapsulePSN205c9c1e-b422-4e86-a4b0-714b608adc193
596918lansoprazole 15 MG Delayed Release Oral Capsule [Prevacid]SBD205c9c1e-b422-4e86-a4b0-714b608adc193
596843lansoprazole 15 MG Delayed Release Oral CapsuleSCD205c9c1e-b422-4e86-a4b0-714b608adc193
596918Prevacid 15 MG Delayed Release Oral CapsuleSY205c9c1e-b422-4e86-a4b0-714b608adc193

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0113-6117-01001136117011 BOTTLE in 1 CARTON (0113-6117-01) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE1 bottle2023-03-30NoNoHistorical
0113-6117-03001136117033 BOTTLE in 1 CARTON (0113-6117-03) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE3 bottle2023-03-30NoNoHistorical