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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
49035-411-01EA - Each49035-41196e14fb1-7a85-4279-a0ee-b19d68161f6a12019-03-12
49035-411-03EA - Each49035-411bd45b9ad-9058-47bb-8cf1-6913a471a16e12017-07-07

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LANSOPRAZOLEACTIVE INGREDIENT0K5C5T2QPGEQUATE LANSOPRAZOLE DELAYED RELEASE (LANSOPRAZOLE) CAPSULE, DELAYED RELEASE [WAL-MART STORES INC]1
LANSOPRAZOLEACTIVE MOIETY0K5C5T2QPGEQUATE LANSOPRAZOLE DELAYED RELEASE (LANSOPRAZOLE) CAPSULE, DELAYED RELEASE [WAL-MART STORES INC]1
D&C RED NO. 28INACTIVE INGREDIENT767IP0Y5NHEQUATE LANSOPRAZOLE DELAYED RELEASE (LANSOPRAZOLE) CAPSULE, DELAYED RELEASE [WAL-MART STORES INC]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GEQUATE LANSOPRAZOLE DELAYED RELEASE (LANSOPRAZOLE) CAPSULE, DELAYED RELEASE [WAL-MART STORES INC]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDEQUATE LANSOPRAZOLE DELAYED RELEASE (LANSOPRAZOLE) CAPSULE, DELAYED RELEASE [WAL-MART STORES INC]1
GELATININACTIVE INGREDIENT2G86QN327LEQUATE LANSOPRAZOLE DELAYED RELEASE (LANSOPRAZOLE) CAPSULE, DELAYED RELEASE [WAL-MART STORES INC]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOEQUATE LANSOPRAZOLE DELAYED RELEASE (LANSOPRAZOLE) CAPSULE, DELAYED RELEASE [WAL-MART STORES INC]1
MANNITOLINACTIVE INGREDIENT3OWL53L36AEQUATE LANSOPRAZOLE DELAYED RELEASE (LANSOPRAZOLE) CAPSULE, DELAYED RELEASE [WAL-MART STORES INC]1
MEGLUMINEINACTIVE INGREDIENT6HG8UB2MUYEQUATE LANSOPRAZOLE DELAYED RELEASE (LANSOPRAZOLE) CAPSULE, DELAYED RELEASE [WAL-MART STORES INC]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AEQUATE LANSOPRAZOLE DELAYED RELEASE (LANSOPRAZOLE) CAPSULE, DELAYED RELEASE [WAL-MART STORES INC]1
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HEQUATE LANSOPRAZOLE DELAYED RELEASE (LANSOPRAZOLE) CAPSULE, DELAYED RELEASE [WAL-MART STORES INC]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JEQUATE LANSOPRAZOLE DELAYED RELEASE (LANSOPRAZOLE) CAPSULE, DELAYED RELEASE [WAL-MART STORES INC]1
TALCINACTIVE INGREDIENT7SEV7J4R1UEQUATE LANSOPRAZOLE DELAYED RELEASE (LANSOPRAZOLE) CAPSULE, DELAYED RELEASE [WAL-MART STORES INC]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPEQUATE LANSOPRAZOLE DELAYED RELEASE (LANSOPRAZOLE) CAPSULE, DELAYED RELEASE [WAL-MART STORES INC]1

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