LANSOPRAZOLE

Product NDC
61919-891
11-digit product format
619190891
Labeler code
61919
Product ID
61919-891_55a64ae4-d52d-4151-85e9-23b34a3ec510
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
LANSOPRAZOLE
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
DIRECT RX
Application
ANDA202366
Marketing category
ANDA
Marketing start
2014-01-01
Marketing end
0000-00-00
Substance
LANSOPRAZOLE
Active strength
30 mg/1
Pharmacologic classes
Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Inhibition Gastric Acid Secretion [PE]
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61919-891-302020-01-31C16284748780-19d75b9d0-d73b-f424-e053-dadaa90a57ceLANSOPRAZOLE
61919-891-602020-01-31C16284748780-19d75b9d0-d73b-f424-e053-dadaa90a57ceLANSOPRAZOLE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-891-30LANSOPRAZOLE30 in 1 BOTTLECAPSULE, DELAYED RELEASE307
61919-891-60LANSOPRAZOLE60 in 1 BOTTLECAPSULE, DELAYED RELEASE607

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-891-30EA - Each61919-8911614f9ce-8824-4ed2-9477-4d2281723f1112015-05-05
61919-891-60EA - Each61919-891601fc200-4783-44de-8c49-041cc570569d12015-12-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LANSOPRAZOLEACTIVE INGREDIENT0K5C5T2QPGLANSOPRAZOLE CAPSULE, DELAYED RELEASE [DIRECT RX]7
LANSOPRAZOLEACTIVE MOIETY0K5C5T2QPGLANSOPRAZOLE CAPSULE, DELAYED RELEASE [DIRECT RX]7
ALCOHOLINACTIVE INGREDIENT3K9958V90MLANSOPRAZOLE CAPSULE, DELAYED RELEASE [DIRECT RX]7
AMMONIAINACTIVE INGREDIENT5138Q19F1XLANSOPRAZOLE CAPSULE, DELAYED RELEASE [DIRECT RX]7
BUTYL ALCOHOLINACTIVE INGREDIENT8PJ61P6TS3LANSOPRAZOLE CAPSULE, DELAYED RELEASE [DIRECT RX]7
D&C RED NO. 28INACTIVE INGREDIENT767IP0Y5NHLANSOPRAZOLE CAPSULE, DELAYED RELEASE [DIRECT RX]7
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDLANSOPRAZOLE CAPSULE, DELAYED RELEASE [DIRECT RX]7
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOALANSOPRAZOLE CAPSULE, DELAYED RELEASE [DIRECT RX]7
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357LANSOPRAZOLE CAPSULE, DELAYED RELEASE [DIRECT RX]7
GELATININACTIVE INGREDIENT2G86QN327LLANSOPRAZOLE CAPSULE, DELAYED RELEASE [DIRECT RX]7
HYDROXYPROPYL CELLULOSE (TYPE E)INACTIVE INGREDIENT66O7AQV0RTLANSOPRAZOLE CAPSULE, DELAYED RELEASE [DIRECT RX]7
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTEDINACTIVE INGREDIENT2165RE0K14LANSOPRAZOLE CAPSULE, DELAYED RELEASE [DIRECT RX]7
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOLANSOPRAZOLE CAPSULE, DELAYED RELEASE [DIRECT RX]7
ISOPROPYL ALCOHOLINACTIVE INGREDIENTND2M416302LANSOPRAZOLE CAPSULE, DELAYED RELEASE [DIRECT RX]7
MAGNESIUM CARBONATEINACTIVE INGREDIENT0E53J927NALANSOPRAZOLE CAPSULE, DELAYED RELEASE [DIRECT RX]7
METHACRYLIC ACIDINACTIVE INGREDIENT1CS02G8656LANSOPRAZOLE CAPSULE, DELAYED RELEASE [DIRECT RX]7
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ALANSOPRAZOLE CAPSULE, DELAYED RELEASE [DIRECT RX]7
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HLANSOPRAZOLE CAPSULE, DELAYED RELEASE [DIRECT RX]7
POTASSIUM HYDROXIDEINACTIVE INGREDIENTWZH3C48M4TLANSOPRAZOLE CAPSULE, DELAYED RELEASE [DIRECT RX]7
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3LANSOPRAZOLE CAPSULE, DELAYED RELEASE [DIRECT RX]7
SHELLACINACTIVE INGREDIENT46N107B71OLANSOPRAZOLE CAPSULE, DELAYED RELEASE [DIRECT RX]7
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJLANSOPRAZOLE CAPSULE, DELAYED RELEASE [DIRECT RX]7
SUCROSEINACTIVE INGREDIENTC151H8M554LANSOPRAZOLE CAPSULE, DELAYED RELEASE [DIRECT RX]7
TALCINACTIVE INGREDIENT7SEV7J4R1ULANSOPRAZOLE CAPSULE, DELAYED RELEASE [DIRECT RX]7
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPLANSOPRAZOLE CAPSULE, DELAYED RELEASE [DIRECT RX]7
WATERINACTIVE INGREDIENT059QF0KO0RLANSOPRAZOLE CAPSULE, DELAYED RELEASE [DIRECT RX]7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-891LANSOPRAZOLE CAPSULE, DELAYED RELEASE [DIRECT RX]7Legacy NDC, 2 package rows20151112_a6d5a2bd-5430-4f93-9700-9b83188618e6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311277lansoprazole 30 MG Delayed Release Oral CapsulePSNa6d5a2bd-5430-4f93-9700-9b83188618e67
311277lansoprazole 30 MG Delayed Release Oral CapsuleSCDa6d5a2bd-5430-4f93-9700-9b83188618e67

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
61919-891-306191908913030 in 1 BOTTLEHistorical
61919-891-606191908916060 in 1 BOTTLEHistorical