FDA.reportPublic FDA data

Lansoprazole

Product NDC
63187-510
11-digit product format
631870510
Labeler code
63187
Product ID
63187-510_06664186-1f92-44f3-b25e-97f1f6a539ea
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
lansoprazole
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA091269
Marketing category
ANDA
Marketing start
2010-10-15
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
63187-510-30Lansoprazole30 in 1 BOTTLECAPSULE, DELAYED RELEASE304
63187-510-60Lansoprazole60 in 1 BOTTLECAPSULE, DELAYED RELEASE604
63187-510-90Lansoprazole90 in 1 BOTTLECAPSULE, DELAYED RELEASE904

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
ammoniaINACTIVE INGREDIENT5138Q19F1XLANSOPRAZOLE CAPSULE, DELAYED RELEASE [PROFICIENT RX LP]1
ferric oxide redINACTIVE INGREDIENT1K09F3G675LANSOPRAZOLE CAPSULE, DELAYED RELEASE [PROFICIENT RX LP]1
ferric oxide yellowINACTIVE INGREDIENTEX438O2MRTLANSOPRAZOLE 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
Hydroxypropyl Cellulose (Type H)INACTIVE INGREDIENTRFW2ET671PLANSOPRAZOLE CAPSULE, DELAYED RELEASE [PROFICIENT RX LP]1
hydroxypropyl cellulose, low substitutedINACTIVE INGREDIENT2165RE0K14LANSOPRAZOLE 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
polyethylene glycolsINACTIVE INGREDIENT3WJQ0SDW1ALANSOPRAZOLE CAPSULE, DELAYED RELEASE [PROFICIENT RX LP]1
polysorbate 80INACTIVE INGREDIENT6OZP39ZG8HLANSOPRAZOLE CAPSULE, DELAYED RELEASE [PROFICIENT RX LP]1
propylene glycolINACTIVE INGREDIENT6DC9Q167V3LANSOPRAZOLE CAPSULE, DELAYED RELEASE [PROFICIENT RX LP]1
raw sugarINACTIVE INGREDIENT8M707QY5GHLANSOPRAZOLE CAPSULE, DELAYED RELEASE [PROFICIENT RX LP]1
shellacINACTIVE INGREDIENT46N107B71OLANSOPRAZOLE CAPSULE, DELAYED RELEASE [PROFICIENT RX LP]1
sodium lauryl sulfateINACTIVE INGREDIENT368GB5141JLANSOPRAZOLE 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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-510LANSOPRAZOLE CAPSULE, DELAYED RELEASE [PROFICIENT RX LP]4Current NDC, Legacy NDC, 3 package rows20221021_3e3e63df-e2ad-420b-acb9-28e65ea6fb07.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311277lansoprazole 30 MG Delayed Release Oral CapsulePSN3e3e63df-e2ad-420b-acb9-28e65ea6fb074
311277lansoprazole 30 MG Delayed Release Oral CapsuleSCD3e3e63df-e2ad-420b-acb9-28e65ea6fb074

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63187-510-306318705103030 CAPSULE, DELAYED RELEASE in 1 BOTTLE (63187-510-30) 2015-07-010000-00-00NoNoCurrent
63187-510-606318705106060 CAPSULE, DELAYED RELEASE in 1 BOTTLE (63187-510-60) 2015-07-010000-00-00NoNoCurrent
63187-510-906318705109090 CAPSULE, DELAYED RELEASE in 1 BOTTLE (63187-510-90) 2015-07-010000-00-00NoNoCurrent