Lansoprazole

Product NDC
63187-152
11-digit product format
631870152
Labeler code
63187
Product ID
63187-152_0ca90194-0255-4661-896a-e066e593bf8a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lansoprazole
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA077255
Marketing category
ANDA
Marketing start
2009-11-11
Substance
LANSOPRAZOLE
Active strength
30 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
LANSOPRAZOLE30 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii0K5C5T2QPG
Rxcui311277

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d6b97638-59f4-48e2-8959-569628732c46Product name920210622
8690a824-4bf8-4d1e-b118-2d6dda86bc04Product name220161206

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63187-152-30Lansoprazole30 in 1 BOTTLECAPSULE, DELAYED RELEASE303

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63187-152-30EA - Each63187-15235b4fcd3-5702-4d67-b62c-d93a0979b08e12016-09-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LANSOPRAZOLEACTIVE INGREDIENT0K5C5T2QPGLANSOPRAZOLE CAPSULE, DELAYED RELEASE [PROFICIENT RX LP]1
LANSOPRAZOLEACTIVE MOIETY0K5C5T2QPGLANSOPRAZOLE CAPSULE, DELAYED RELEASE [PROFICIENT RX LP]1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675LANSOPRAZOLE CAPSULE, DELAYED RELEASE [PROFICIENT RX LP]1
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357LANSOPRAZOLE CAPSULE, DELAYED RELEASE [PROFICIENT RX LP]1
GELATININACTIVE INGREDIENT2G86QN327LLANSOPRAZOLE CAPSULE, DELAYED RELEASE [PROFICIENT RX LP]1
HYPROMELLOSE 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6LANSOPRAZOLE CAPSULE, DELAYED RELEASE [PROFICIENT RX LP]1
MAGNESIUM CARBONATEINACTIVE INGREDIENT0E53J927NALANSOPRAZOLE CAPSULE, DELAYED RELEASE [PROFICIENT RX LP]1
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AINACTIVE INGREDIENTNX76LV5T8JLANSOPRAZOLE CAPSULE, DELAYED RELEASE [PROFICIENT RX LP]1
POTASSIUM HYDROXIDEINACTIVE INGREDIENTWZH3C48M4TLANSOPRAZOLE CAPSULE, DELAYED RELEASE [PROFICIENT RX LP]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3LANSOPRAZOLE CAPSULE, DELAYED RELEASE [PROFICIENT RX LP]1
SHELLACINACTIVE INGREDIENT46N107B71OLANSOPRAZOLE CAPSULE, DELAYED RELEASE [PROFICIENT RX LP]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJLANSOPRAZOLE CAPSULE, DELAYED RELEASE [PROFICIENT RX LP]1
SUCROSEINACTIVE INGREDIENTC151H8M554LANSOPRAZOLE CAPSULE, DELAYED RELEASE [PROFICIENT RX LP]1
TALCINACTIVE INGREDIENT7SEV7J4R1ULANSOPRAZOLE CAPSULE, DELAYED RELEASE [PROFICIENT RX LP]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPLANSOPRAZOLE CAPSULE, DELAYED RELEASE [PROFICIENT RX LP]1
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMLANSOPRAZOLE CAPSULE, DELAYED RELEASE [PROFICIENT RX LP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-152LANSOPRAZOLE CAPSULE, DELAYED RELEASE [PROFICIENT RX LP]3Current NDC, Legacy NDC, 1 package rows20210121_7d811f01-f0c2-4753-bb36-80b48dabb58c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311277lansoprazole 30 MG Delayed Release Oral CapsulePSN7d811f01-f0c2-4753-bb36-80b48dabb58c3
311277lansoprazole 30 MG Delayed Release Oral CapsuleSCD7d811f01-f0c2-4753-bb36-80b48dabb58c3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63187-152-306318701523030 CAPSULE, DELAYED RELEASE in 1 BOTTLE (63187-152-30) 2019-01-010000-00-00NoNoCurrent