Lansoprazole

Product NDC
0093-7350
11-digit product format
000937350
Labeler code
0093
Product ID
0093-7350_cff4a734-b698-4be2-88f2-058914575919
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lansoprazole
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
Teva Pharmaceuticals USA, Inc.
Application
ANDA077255
Marketing category
ANDA
Marketing start
2009-11-11
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
Lansoprazole
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LANSOPRAZOLE15 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii0K5C5T2QPG
Rxcui311277, 596843

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
0093-7350-56Lansoprazole30 in 1 BOTTLECAPSULE, DELAYED RELEASE3025

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0093-7350-56EA - Each0093-7350d56d5cfa-6310-4762-88f8-125893b9da2712012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LANSOPRAZOLEACTIVE INGREDIENT0K5C5T2QPGLANSOPRAZOLE CAPSULE, DELAYED RELEASE [TEVA PHARMACEUTICALS USA INC]14
LANSOPRAZOLEACTIVE MOIETY0K5C5T2QPGLANSOPRAZOLE CAPSULE, DELAYED RELEASE [TEVA PHARMACEUTICALS USA INC]14
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDLANSOPRAZOLE CAPSULE, DELAYED RELEASE [TEVA PHARMACEUTICALS USA INC]14
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675LANSOPRAZOLE CAPSULE, DELAYED RELEASE [TEVA PHARMACEUTICALS USA INC]14
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357LANSOPRAZOLE CAPSULE, DELAYED RELEASE [TEVA PHARMACEUTICALS USA INC]14
GELATININACTIVE INGREDIENT2G86QN327LLANSOPRAZOLE CAPSULE, DELAYED RELEASE [TEVA PHARMACEUTICALS USA INC]14
HYPROMELLOSE 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6LANSOPRAZOLE CAPSULE, DELAYED RELEASE [TEVA PHARMACEUTICALS USA INC]14
MAGNESIUM CARBONATEINACTIVE INGREDIENT0E53J927NALANSOPRAZOLE CAPSULE, DELAYED RELEASE [TEVA PHARMACEUTICALS USA INC]14
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AINACTIVE INGREDIENTNX76LV5T8JLANSOPRAZOLE CAPSULE, DELAYED RELEASE [TEVA PHARMACEUTICALS USA INC]14
POTASSIUM HYDROXIDEINACTIVE INGREDIENTWZH3C48M4TLANSOPRAZOLE CAPSULE, DELAYED RELEASE [TEVA PHARMACEUTICALS USA INC]14
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3LANSOPRAZOLE CAPSULE, DELAYED RELEASE [TEVA PHARMACEUTICALS USA INC]14
SHELLACINACTIVE INGREDIENT46N107B71OLANSOPRAZOLE CAPSULE, DELAYED RELEASE [TEVA PHARMACEUTICALS USA INC]14
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJLANSOPRAZOLE CAPSULE, DELAYED RELEASE [TEVA PHARMACEUTICALS USA INC]14
SUCROSEINACTIVE INGREDIENTC151H8M554LANSOPRAZOLE CAPSULE, DELAYED RELEASE [TEVA PHARMACEUTICALS USA INC]14
TALCINACTIVE INGREDIENT7SEV7J4R1ULANSOPRAZOLE CAPSULE, DELAYED RELEASE [TEVA PHARMACEUTICALS USA INC]14
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPLANSOPRAZOLE CAPSULE, DELAYED RELEASE [TEVA PHARMACEUTICALS USA INC]14
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMLANSOPRAZOLE CAPSULE, DELAYED RELEASE [TEVA PHARMACEUTICALS USA INC]14
LANSOPRAZOLEACTIVE INGREDIENT0K5C5T2QPGLANSOPRAZOLE CAPSULE, DELAYED RELEASE [PHYSICIANS TOTAL CARE, INC.]4
LANSOPRAZOLEACTIVE MOIETY0K5C5T2QPGLANSOPRAZOLE CAPSULE, DELAYED RELEASE [PHYSICIANS TOTAL CARE, INC.]4
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDLANSOPRAZOLE CAPSULE, DELAYED RELEASE [PHYSICIANS TOTAL CARE, INC.]4
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675LANSOPRAZOLE CAPSULE, DELAYED RELEASE [PHYSICIANS TOTAL CARE, INC.]4
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357LANSOPRAZOLE CAPSULE, DELAYED RELEASE [PHYSICIANS TOTAL CARE, INC.]4
GELATININACTIVE INGREDIENT2G86QN327LLANSOPRAZOLE CAPSULE, DELAYED RELEASE [PHYSICIANS TOTAL CARE, INC.]4
HYPROMELLOSE 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6LANSOPRAZOLE CAPSULE, DELAYED RELEASE [PHYSICIANS TOTAL CARE, INC.]4
MAGNESIUM CARBONATEINACTIVE INGREDIENT0E53J927NALANSOPRAZOLE CAPSULE, DELAYED RELEASE [PHYSICIANS TOTAL CARE, INC.]4
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AINACTIVE INGREDIENTNX76LV5T8JLANSOPRAZOLE CAPSULE, DELAYED RELEASE [PHYSICIANS TOTAL CARE, INC.]4
POTASSIUM HYDROXIDEINACTIVE INGREDIENTWZH3C48M4TLANSOPRAZOLE CAPSULE, DELAYED RELEASE [PHYSICIANS TOTAL CARE, INC.]4
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3LANSOPRAZOLE CAPSULE, DELAYED RELEASE [PHYSICIANS TOTAL CARE, INC.]4
SHELLACINACTIVE INGREDIENT46N107B71OLANSOPRAZOLE CAPSULE, DELAYED RELEASE [PHYSICIANS TOTAL CARE, INC.]4
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJLANSOPRAZOLE CAPSULE, DELAYED RELEASE [PHYSICIANS TOTAL CARE, INC.]4
SUCROSEINACTIVE INGREDIENTC151H8M554LANSOPRAZOLE CAPSULE, DELAYED RELEASE [PHYSICIANS TOTAL CARE, INC.]4
TALCINACTIVE INGREDIENT7SEV7J4R1ULANSOPRAZOLE CAPSULE, DELAYED RELEASE [PHYSICIANS TOTAL CARE, INC.]4
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPLANSOPRAZOLE CAPSULE, DELAYED RELEASE [PHYSICIANS TOTAL CARE, INC.]4
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMLANSOPRAZOLE CAPSULE, DELAYED RELEASE [PHYSICIANS TOTAL CARE, INC.]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0093-7350LANSOPRAZOLE CAPSULE, DELAYED RELEASE [TEVA PHARMACEUTICALS USA, INC.]25Current NDC, Legacy NDC, 1 package rows20220626_427cf924-be17-47dc-8f77-115fa2f3fe17.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
596843lansoprazole 15 MG Delayed Release Oral CapsulePSN427cf924-be17-47dc-8f77-115fa2f3fe1725
311277lansoprazole 30 MG Delayed Release Oral CapsulePSN427cf924-be17-47dc-8f77-115fa2f3fe1725
596843lansoprazole 15 MG Delayed Release Oral CapsuleSCD427cf924-be17-47dc-8f77-115fa2f3fe1725
311277lansoprazole 30 MG Delayed Release Oral CapsuleSCD427cf924-be17-47dc-8f77-115fa2f3fe1725
596843lansoprazole 15 MG Delayed Release Oral CapsulePSNe33ac27f-43ae-4912-8e41-626091fc5ad24
311277lansoprazole 30 MG Delayed Release Oral CapsulePSNe33ac27f-43ae-4912-8e41-626091fc5ad24
596843lansoprazole 15 MG Delayed Release Oral CapsuleSCDe33ac27f-43ae-4912-8e41-626091fc5ad24
311277lansoprazole 30 MG Delayed Release Oral CapsuleSCDe33ac27f-43ae-4912-8e41-626091fc5ad24

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0093-7350-560009373505630 CAPSULE, DELAYED RELEASE in 1 BOTTLE (0093-7350-56) 2009-11-110000-00-00NoNoCurrent