equate lansoprazole delayed release

Product NDC
49035-411
11-digit product format
490350411
Labeler code
49035
Product ID
49035-411_c77bb311-5eed-4a6b-8f0f-09371f123e92
Type
HUMAN OTC DRUG
Nonproprietary name
Lansoprazole
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
Wal-Mart Stores Inc
Application
ANDA202319
Marketing category
ANDA
Marketing start
2014-05-05
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
equate lansoprazole delayed release
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LANSOPRAZOLE15 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii0K5C5T2QPG
Rxcui596843

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
49035-411-01equate lansoprazole delayed release1 in 1 CARTONCAPSULE, DELAYED RELEASE15
49035-411-01equate lansoprazole delayed release14 in 1 BOTTLECAPSULE, DELAYED RELEASE145
49035-411-03equate lansoprazole delayed release14 in 1 BOTTLECAPSULE, DELAYED RELEASE145
49035-411-03equate lansoprazole delayed release3 in 1 CARTONCAPSULE, DELAYED RELEASE35

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49035-411EQUATE LANSOPRAZOLE DELAYED RELEASE (LANSOPRAZOLE) CAPSULE, DELAYED RELEASE [WAL-MART STORES INC]5Current NDC, Legacy NDC, 4 package rows20200514_3eb7a657-625a-46bf-a196-4ba6aa41a7bf.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
596843lansoprazole 15 MG Delayed Release Oral CapsulePSN3eb7a657-625a-46bf-a196-4ba6aa41a7bf5
596843lansoprazole 15 MG Delayed Release Oral CapsuleSCD3eb7a657-625a-46bf-a196-4ba6aa41a7bf5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49035-411-01490350411011 BOTTLE in 1 CARTON (49035-411-01) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE1 bottle2014-05-050000-00-00NoNoCurrent
49035-411-03490350411033 BOTTLE in 1 CARTON (49035-411-03) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE3 bottle2014-05-070000-00-00NoNoCurrent