FDA.reportPublic FDA data

Dexilant

Product NDC
64764-175
11-digit product format
647640175
Labeler code
64764
Product ID
64764-175_402fdd3a-6183-4a0d-85ac-61d4221fc921
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
dexlansoprazole
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
Takeda Pharmaceuticals America, Inc.
Application
NDA022287
Marketing category
NDA
Marketing start
2010-04-12
Substance
DEXLANSOPRAZOLE
Active strength
60 mg/1
Pharmacologic classes
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
Dexilant
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DEXLANSOPRAZOLE60 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiUYE4T5I70X
Rxcui833204, 833213, 902624, 902626

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
9e37788c-b1bf-42ae-aac9-b60601606144Product name820260122
1527ac37-808d-43be-a63e-74e1258dbe46Product name920250219
72065c97-63d2-e1f2-e507-59f0b1c78119Product name520250114
bed0530e-f939-4541-956b-6928a2f6404fProduct name120241008
cefa60e2-a5b5-493e-9c54-24735b7dc509Product name620240814
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
9fcb7a91-de07-4f00-aabf-e4d6fda403d5Product name820230322
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
9badc7be-250a-44ab-aa36-926af3f02679Product name120210527
0ec3537a-6c9b-432a-896c-b9ea8723049aProduct name920200701
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
7916de40-e296-41f0-b811-6d0df1a33e2cProduct name920180627
cefa60e2-a5b5-493e-9c54-24735b7dc509Product name220171212
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
64764-175-00Dexilant7 in 1 BOTTLECAPSULE, DELAYED RELEASE740
64764-175-01Dexilant4 in 1 BLISTER PACKCAPSULE, DELAYED RELEASE440
64764-175-01Dexilant5 in 1 TRAYCAPSULE, DELAYED RELEASE540
64764-175-02Dexilant30 in 1 BOTTLECAPSULE, DELAYED RELEASE3040
64764-175-11Dexilant10 in 1 CARTONCAPSULE, DELAYED RELEASE1040
64764-175-11Dexilant10 in 1 BLISTER PACKCAPSULE, DELAYED RELEASE1040
64764-175-19Dexilant1000 in 1 BOTTLECAPSULE, DELAYED RELEASE100040
64764-175-30Dexilant30 in 1 BOTTLECAPSULE, DELAYED RELEASE3040
64764-175-90Dexilant90 in 1 BOTTLECAPSULE, DELAYED RELEASE9040

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
64764-175-30EA - Each64764-175a62a3be6-3b8a-4c70-af79-0f025113de1f12012-07-24
64764-175-90EA - Each64764-175e3ec23ff-a658-4dea-bff3-bbc0c0fd6cec12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
dexlansoprazoleACTIVE INGREDIENTUYE4T5I70XDEXILANT (DEXLANSOPRAZOLE) CAPSULE, DELAYED RELEASE [TAKEDA PHARMACEUTICALS AMERICA, INC.]17
dexlansoprazoleACTIVE MOIETYUYE4T5I70XDEXILANT (DEXLANSOPRAZOLE) CAPSULE, DELAYED RELEASE [TAKEDA PHARMACEUTICALS AMERICA, INC.]17
aluminum oxideINACTIVE INGREDIENTLMI26O6933DEXILANT (DEXLANSOPRAZOLE) CAPSULE, DELAYED RELEASE [TAKEDA PHARMACEUTICALS AMERICA, INC.]17
carrageenanINACTIVE INGREDIENT5C69YCD2YJDEXILANT (DEXLANSOPRAZOLE) CAPSULE, DELAYED RELEASE [TAKEDA PHARMACEUTICALS AMERICA, INC.]17
FD&C Blue No. 2INACTIVE INGREDIENTL06K8R7DQKDEXILANT (DEXLANSOPRAZOLE) CAPSULE, DELAYED RELEASE [TAKEDA PHARMACEUTICALS AMERICA, INC.]17
ferric oxide redINACTIVE INGREDIENT1K09F3G675DEXILANT (DEXLANSOPRAZOLE) CAPSULE, DELAYED RELEASE [TAKEDA PHARMACEUTICALS AMERICA, INC.]17
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PDEXILANT (DEXLANSOPRAZOLE) CAPSULE, DELAYED RELEASE [TAKEDA PHARMACEUTICALS AMERICA, INC.]17
hydroxypropyl cellulose, low substitutedINACTIVE INGREDIENT2165RE0K14DEXILANT (DEXLANSOPRAZOLE) CAPSULE, DELAYED RELEASE [TAKEDA PHARMACEUTICALS AMERICA, INC.]17
HYPROMELLOSE 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6DEXILANT (DEXLANSOPRAZOLE) CAPSULE, DELAYED RELEASE [TAKEDA PHARMACEUTICALS AMERICA, INC.]17
magnesium carbonateINACTIVE INGREDIENT0E53J927NADEXILANT (DEXLANSOPRAZOLE) CAPSULE, DELAYED RELEASE [TAKEDA PHARMACEUTICALS AMERICA, INC.]17
Methacrylic Acid - Ethyl Acrylate Copolymer (1:1) Type AINACTIVE INGREDIENTNX76LV5T8JDEXILANT (DEXLANSOPRAZOLE) CAPSULE, DELAYED RELEASE [TAKEDA PHARMACEUTICALS AMERICA, INC.]17
Methacrylic Acid - Methyl Methacrylate Copolymer (1:1)INACTIVE INGREDIENT74G4R6TH13DEXILANT (DEXLANSOPRAZOLE) CAPSULE, DELAYED RELEASE [TAKEDA PHARMACEUTICALS AMERICA, INC.]17
Methacrylic Acid - Methyl Methacrylate Copolymer (1:2)INACTIVE INGREDIENT5KY68S2577DEXILANT (DEXLANSOPRAZOLE) CAPSULE, DELAYED RELEASE [TAKEDA PHARMACEUTICALS AMERICA, INC.]17
polyethylene glycol 8000INACTIVE INGREDIENTQ662QK8M3BDEXILANT (DEXLANSOPRAZOLE) CAPSULE, DELAYED RELEASE [TAKEDA PHARMACEUTICALS AMERICA, INC.]17
polysorbate 80INACTIVE INGREDIENT6OZP39ZG8HDEXILANT (DEXLANSOPRAZOLE) CAPSULE, DELAYED RELEASE [TAKEDA PHARMACEUTICALS AMERICA, INC.]17
potassium chlorideINACTIVE INGREDIENT660YQ98I10DEXILANT (DEXLANSOPRAZOLE) CAPSULE, DELAYED RELEASE [TAKEDA PHARMACEUTICALS AMERICA, INC.]17
silicon dioxideINACTIVE INGREDIENTETJ7Z6XBU4DEXILANT (DEXLANSOPRAZOLE) CAPSULE, DELAYED RELEASE [TAKEDA PHARMACEUTICALS AMERICA, INC.]17
sucroseINACTIVE INGREDIENTC151H8M554DEXILANT (DEXLANSOPRAZOLE) CAPSULE, DELAYED RELEASE [TAKEDA PHARMACEUTICALS AMERICA, INC.]17
talcINACTIVE INGREDIENT7SEV7J4R1UDEXILANT (DEXLANSOPRAZOLE) CAPSULE, DELAYED RELEASE [TAKEDA PHARMACEUTICALS AMERICA, INC.]17
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPDEXILANT (DEXLANSOPRAZOLE) CAPSULE, DELAYED RELEASE [TAKEDA PHARMACEUTICALS AMERICA, INC.]17
triethyl citrateINACTIVE INGREDIENT8Z96QXD6UMDEXILANT (DEXLANSOPRAZOLE) CAPSULE, DELAYED RELEASE [TAKEDA PHARMACEUTICALS AMERICA, INC.]17
dexlansoprazoleACTIVE INGREDIENTUYE4T5I70XDEXILANT (DEXLANSOPRAZOLE) CAPSULE, DELAYED RELEASE [PHYSICIANS TOTAL CARE, INC.]2
dexlansoprazoleACTIVE MOIETYUYE4T5I70XDEXILANT (DEXLANSOPRAZOLE) CAPSULE, DELAYED RELEASE [PHYSICIANS TOTAL CARE, INC.]2
aluminum oxideINACTIVE INGREDIENTLMI26O6933DEXILANT (DEXLANSOPRAZOLE) CAPSULE, DELAYED RELEASE [PHYSICIANS TOTAL CARE, INC.]2
carrageenanINACTIVE INGREDIENT5C69YCD2YJDEXILANT (DEXLANSOPRAZOLE) CAPSULE, DELAYED RELEASE [PHYSICIANS TOTAL CARE, INC.]2
FD&C Blue No. 2INACTIVE INGREDIENTL06K8R7DQKDEXILANT (DEXLANSOPRAZOLE) CAPSULE, DELAYED RELEASE [PHYSICIANS TOTAL CARE, INC.]2
hydroxypropyl celluloseINACTIVE INGREDIENTRFW2ET671PDEXILANT (DEXLANSOPRAZOLE) CAPSULE, DELAYED RELEASE [PHYSICIANS TOTAL CARE, INC.]2
hydroxypropyl cellulose, low substitutedINACTIVE INGREDIENT2165RE0K14DEXILANT (DEXLANSOPRAZOLE) CAPSULE, DELAYED RELEASE [PHYSICIANS TOTAL CARE, INC.]2
hypromellosesINACTIVE INGREDIENT3NXW29V3WODEXILANT (DEXLANSOPRAZOLE) CAPSULE, DELAYED RELEASE [PHYSICIANS TOTAL CARE, INC.]2
magnesium carbonateINACTIVE INGREDIENT0E53J927NADEXILANT (DEXLANSOPRAZOLE) CAPSULE, DELAYED RELEASE [PHYSICIANS TOTAL CARE, INC.]2
Methacrylic Acid - Ethyl Acrylate Copolymer (1:1) Type AINACTIVE INGREDIENTNX76LV5T8JDEXILANT (DEXLANSOPRAZOLE) CAPSULE, DELAYED RELEASE [PHYSICIANS TOTAL CARE, INC.]2
Methacrylic Acid - Methyl Methacrylate Copolymer (1:1)INACTIVE INGREDIENT74G4R6TH13DEXILANT (DEXLANSOPRAZOLE) CAPSULE, DELAYED RELEASE [PHYSICIANS TOTAL CARE, INC.]2
Methacrylic Acid - Methyl Methacrylate Copolymer (1:2)INACTIVE INGREDIENT5KY68S2577DEXILANT (DEXLANSOPRAZOLE) CAPSULE, DELAYED RELEASE [PHYSICIANS TOTAL CARE, INC.]2
polyethylene glycol 8000INACTIVE INGREDIENTQ662QK8M3BDEXILANT (DEXLANSOPRAZOLE) CAPSULE, DELAYED RELEASE [PHYSICIANS TOTAL CARE, INC.]2
polysorbate 80INACTIVE INGREDIENT6OZP39ZG8HDEXILANT (DEXLANSOPRAZOLE) CAPSULE, DELAYED RELEASE [PHYSICIANS TOTAL CARE, INC.]2
potassium chlorideINACTIVE INGREDIENT660YQ98I10DEXILANT (DEXLANSOPRAZOLE) CAPSULE, DELAYED RELEASE [PHYSICIANS TOTAL CARE, INC.]2
silicon dioxideINACTIVE INGREDIENTETJ7Z6XBU4DEXILANT (DEXLANSOPRAZOLE) CAPSULE, DELAYED RELEASE [PHYSICIANS TOTAL CARE, INC.]2
sucroseINACTIVE INGREDIENTC151H8M554DEXILANT (DEXLANSOPRAZOLE) CAPSULE, DELAYED RELEASE [PHYSICIANS TOTAL CARE, INC.]2
talcINACTIVE INGREDIENT7SEV7J4R1UDEXILANT (DEXLANSOPRAZOLE) CAPSULE, DELAYED RELEASE [PHYSICIANS TOTAL CARE, INC.]2
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPDEXILANT (DEXLANSOPRAZOLE) CAPSULE, DELAYED RELEASE [PHYSICIANS TOTAL CARE, INC.]2
triethyl citrateINACTIVE INGREDIENT8Z96QXD6UMDEXILANT (DEXLANSOPRAZOLE) CAPSULE, DELAYED RELEASE [PHYSICIANS TOTAL CARE, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64764-175DEXILANT (DEXLANSOPRAZOLE) CAPSULE, DELAYED RELEASE [TAKEDA PHARMACEUTICALS AMERICA, INC.]40Current NDC, Legacy NDC, 9 package rows20250223_9819f033-3bbe-442e-8e92-45fec77b237d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
902624Dexilant 30 MG Delayed Release Oral CapsulePSN9819f033-3bbe-442e-8e92-45fec77b237d40
902626Dexilant 60 MG Delayed Release Oral CapsulePSN9819f033-3bbe-442e-8e92-45fec77b237d40
833204dexlansoprazole 30 MG Delayed Release Oral CapsulePSN9819f033-3bbe-442e-8e92-45fec77b237d40
833213dexlansoprazole 60 MG Delayed Release Oral CapsulePSN9819f033-3bbe-442e-8e92-45fec77b237d40
902624dexlansoprazole 30 MG Delayed Release Oral Capsule [Dexilant]SBD9819f033-3bbe-442e-8e92-45fec77b237d40
902626dexlansoprazole 60 MG Delayed Release Oral Capsule [Dexilant]SBD9819f033-3bbe-442e-8e92-45fec77b237d40
833204dexlansoprazole 30 MG Delayed Release Oral CapsuleSCD9819f033-3bbe-442e-8e92-45fec77b237d40
833213dexlansoprazole 60 MG Delayed Release Oral CapsuleSCD9819f033-3bbe-442e-8e92-45fec77b237d40
902624Dexilant 30 MG Delayed Release Oral CapsuleSY9819f033-3bbe-442e-8e92-45fec77b237d40
902626Dexilant 60 MG Delayed Release Oral CapsuleSY9819f033-3bbe-442e-8e92-45fec77b237d40
902626Dexilant 60 MG Delayed Release Oral CapsulePSNd62d754e-2310-4912-b022-603ae925710d2
833213dexlansoprazole 60 MG Delayed Release Oral CapsulePSNd62d754e-2310-4912-b022-603ae925710d2
902626dexlansoprazole 60 MG Delayed Release Oral Capsule [Dexilant]SBDd62d754e-2310-4912-b022-603ae925710d2
833213dexlansoprazole 60 MG Delayed Release Oral CapsuleSCDd62d754e-2310-4912-b022-603ae925710d2
902626Dexilant 60 MG Delayed Release Oral CapsuleSYd62d754e-2310-4912-b022-603ae925710d2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
64764-175-00647640175007 CAPSULE, DELAYED RELEASE in 1 BOTTLE (64764-175-00) 2010-04-120000-00-00NoNoCurrent
64764-175-01647640175015 BLISTER PACK in 1 TRAY (64764-175-01) / 4 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK5 blister pack2010-04-120000-00-00NoNoCurrent
64764-175-026476401750230 CAPSULE, DELAYED RELEASE in 1 BOTTLE (64764-175-02) 2010-04-120000-00-00NoNoCurrent
64764-175-116476401751110 BLISTER PACK in 1 CARTON (64764-175-11) / 10 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK10 blister pack2010-04-120000-00-00NoNoCurrent
64764-175-19647640175191000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (64764-175-19) 2010-04-120000-00-00NoNoCurrent
64764-175-306476401753030 CAPSULE, DELAYED RELEASE in 1 BOTTLE (64764-175-30) 2010-04-120000-00-00NoNoCurrent
64764-175-906476401759090 CAPSULE, DELAYED RELEASE in 1 BOTTLE (64764-175-90) 2010-04-120000-00-00NoNoCurrent