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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N022287-001DEXILANTDEXLANSOPRAZOLE30MGCAPSULE, DELAYED RELEASE / ORALABRLD2009-01-30
N022287-002DEXILANTDEXLANSOPRAZOLE60MGCAPSULE, DELAYED RELEASE / ORALABRLD, RS2009-01-30

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
N022287-001AB
N022287-002AB

Orange Book patents#

Current patent rows page 1 of 1 · 28 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N022287-00184611872026-01-17Drug product
N022287-00192380292026-01-17Drug product2016-02-11
N022287-00190119262026-02-24Drug product2015-05-01
N022287-0018461187*PED2026-07-17Pediatric extension
N022287-00177907552026-08-02Drug product2010-09-29
N022287-00181056262026-09-27Drug product2012-02-28
N022287-0017790755*PED2027-02-02Pediatric extension
N022287-0018105626*PED2027-03-27Pediatric extension
N022287-00188712732028-01-11Drug product2014-12-01
N022287-00181731582030-03-17U-9492012-06-01
N022287-00181731582030-03-17U-9502012-06-01
N022287-00181731582030-03-17U-9512012-06-01
N022287-0018173158*PED2030-09-17Pediatric extension
N022287-00192331032032-03-05U-18052016-02-11
N022287-00284611872026-01-17Drug product
N022287-00292380292026-01-17Drug product2016-02-11
N022287-00290119262026-02-24Drug product2015-05-01
N022287-0028461187*PED2026-07-17Pediatric extension
N022287-00277907552026-08-02Drug product
N022287-00281056262026-09-27Drug product
N022287-0027790755*PED2027-02-02Pediatric extension
N022287-0028105626*PED2027-03-27Pediatric extension
N022287-00288712732028-01-11Drug product2014-12-01
N022287-00281731582030-03-17U-949
N022287-00281731582030-03-17U-950
N022287-00281731582030-03-17U-951
N022287-0028173158*PED2030-09-17Pediatric extension
N022287-00292331032032-03-05U-18052016-02-11

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 3 · 86 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08N022287-001DEXILANT30MGCAPSULE, DELAYED RELEASE / ORALABRLD2009-01-3084e616aacf4f…
2026-09-14 22:38:342026-08N022287-002DEXILANT60MGCAPSULE, DELAYED RELEASE / ORALABRLD, RS2009-01-3084e616aacf4f…
2026-08-18 06:07:402026-07N022287-001DEXILANT30MGCAPSULE, DELAYED RELEASE / ORALABRLD2009-01-30caaa826d4ba7…
2026-08-18 06:07:402026-07N022287-002DEXILANT60MGCAPSULE, DELAYED RELEASE / ORALABRLD, RS2009-01-30caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N022287-001DEXILANT30MGCAPSULE, DELAYED RELEASE / ORALABRLD2009-01-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022287-002DEXILANT60MGCAPSULE, DELAYED RELEASE / ORALABRLD, RS2009-01-30011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022287-001DEXILANT30MGCAPSULE, DELAYED RELEASE / ORALABRLD2009-01-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022287-002DEXILANT60MGCAPSULE, DELAYED RELEASE / ORALABRLD, RS2009-01-3031067a03dcf5…
2025-08-23 18:47 UTC2025-08N022287-001DEXILANT30MGCAPSULE, DELAYED RELEASE / ORALABRLD2009-01-306a471c1ec25d…
2025-08-23 18:47 UTC2025-08N022287-002DEXILANT60MGCAPSULE, DELAYED RELEASE / ORALABRLD, RS2009-01-306a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022287-001DEXILANT30MGCAPSULE, DELAYED RELEASE / ORALABRLD2009-01-30fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022287-002DEXILANT60MGCAPSULE, DELAYED RELEASE / ORALABRLD, RS2009-01-30fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N022287-001DEXILANT30MGCAPSULE, DELAYED RELEASE / ORALABRLD2009-01-30b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N022287-002DEXILANT60MGCAPSULE, DELAYED RELEASE / ORALABRLD, RS2009-01-30b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N022287-001DEXILANT30MGCAPSULE, DELAYED RELEASE / ORALABRLD2009-01-3003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N022287-002DEXILANT60MGCAPSULE, DELAYED RELEASE / ORALABRLD, RS2009-01-3003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N022287-001DEXILANT30MGCAPSULE, DELAYED RELEASE / ORALABRLD2009-01-302680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N022287-002DEXILANT60MGCAPSULE, DELAYED RELEASE / ORALABRLD, RS2009-01-302680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N022287-001DEXILANT30MGCAPSULE, DELAYED RELEASE / ORALABRLD2009-01-305bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N022287-002DEXILANT60MGCAPSULE, DELAYED RELEASE / ORALABRLD, RS2009-01-305bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N022287-001DEXILANT30MGCAPSULE, DELAYED RELEASE / ORALABRLD2009-01-30d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N022287-002DEXILANT60MGCAPSULE, DELAYED RELEASE / ORALABRLD, RS2009-01-30d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N022287-001DEXILANT30MGCAPSULE, DELAYED RELEASE / ORALABRLD2009-01-30d06236e962d9…
2024-10-29 15:01 UTC2024-10N022287-002DEXILANT60MGCAPSULE, DELAYED RELEASE / ORALABRLD, RS2009-01-30d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N022287-001DEXILANT30MGCAPSULE, DELAYED RELEASE / ORALABRLD2009-01-3079d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N022287-002DEXILANT60MGCAPSULE, DELAYED RELEASE / ORALABRLD, RS2009-01-3079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N022287-001DEXILANT30MGCAPSULE, DELAYED RELEASE / ORALABRLD2009-01-30301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N022287-002DEXILANT60MGCAPSULE, DELAYED RELEASE / ORALABRLD, RS2009-01-30301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N022287-001DEXILANT30MGCAPSULE, DELAYED RELEASE / ORALABRLD2009-01-301e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N022287-002DEXILANT60MGCAPSULE, DELAYED RELEASE / ORALABRLD, RS2009-01-301e350fbaab3a…
2024-05-31 18:47 UTC2024-05N022287-001DEXILANT30MGCAPSULE, DELAYED RELEASE / ORALABRLD2009-01-308072bd15b7f6…
2024-05-31 18:47 UTC2024-05N022287-002DEXILANT60MGCAPSULE, DELAYED RELEASE / ORALABRLD, RS2009-01-308072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N022287-001DEXILANT30MGCAPSULE, DELAYED RELEASE / ORALRLD2009-01-305c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N022287-002DEXILANT60MGCAPSULE, DELAYED RELEASE / ORALABRLD, RS2009-01-305c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N022287-001DEXILANT30MGCAPSULE, DELAYED RELEASE / ORALRLD2009-01-305d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N022287-002DEXILANT60MGCAPSULE, DELAYED RELEASE / ORALABRLD, RS2009-01-305d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N022287-001DEXILANT30MGCAPSULE, DELAYED RELEASE / ORALRLD2009-01-304b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N022287-002DEXILANT60MGCAPSULE, DELAYED RELEASE / ORALABRLD, RS2009-01-304b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N022287-001DEXILANT30MGCAPSULE, DELAYED RELEASE / ORALRLD2009-01-3074a2ff9319b5…
2019-12-13 00:20 UTC2019-12N022287-002DEXILANT60MGCAPSULE, DELAYED RELEASE / ORALABRLD, RS2009-01-3074a2ff9319b5…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 73 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08N022287-001AB184e616aacf4f…
2026-09-14 22:38:342026-08N022287-002AB184e616aacf4f…
2026-08-18 06:07:402026-07N022287-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07N022287-002AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N022287-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022287-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022287-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022287-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08N022287-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N022287-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022287-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022287-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N022287-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N022287-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N022287-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N022287-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N022287-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N022287-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N022287-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N022287-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N022287-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N022287-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N022287-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10N022287-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N022287-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N022287-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N022287-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N022287-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N022287-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N022287-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05N022287-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05N022287-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N022287-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N022287-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N022287-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N022287-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03N022287-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N022287-002AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N022287-002AB187673890dc5c…
2021-03-12 10:30 UTC2021-03N022287-002AB15aa47cf7b7d7…

Observed Orange Book patent history#

Patent history page 1 of 48 · 1,908 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-09-14 22:38:342026-08N022287-00184611872026-01-17Drug product84e616aacf4f…
2026-09-14 22:38:342026-08N022287-00192380292026-01-17Drug product2016-02-1184e616aacf4f…
2026-09-14 22:38:342026-08N022287-00190119262026-02-24Drug product2015-05-0184e616aacf4f…
2026-09-14 22:38:342026-08N022287-0018461187*PED2026-07-17Pediatric extension84e616aacf4f…
2026-09-14 22:38:342026-08N022287-00177907552026-08-02Drug product2010-09-2984e616aacf4f…
2026-09-14 22:38:342026-08N022287-00181056262026-09-27Drug product2012-02-2884e616aacf4f…
2026-09-14 22:38:342026-08N022287-0017790755*PED2027-02-02Pediatric extension84e616aacf4f…
2026-09-14 22:38:342026-08N022287-0018105626*PED2027-03-27Pediatric extension84e616aacf4f…
2026-09-14 22:38:342026-08N022287-00188712732028-01-11Drug product2014-12-0184e616aacf4f…
2026-09-14 22:38:342026-08N022287-00181731582030-03-17U-9512012-06-0184e616aacf4f…
2026-09-14 22:38:342026-08N022287-00181731582030-03-17U-9492012-06-0184e616aacf4f…
2026-09-14 22:38:342026-08N022287-00181731582030-03-17U-9502012-06-0184e616aacf4f…
2026-09-14 22:38:342026-08N022287-0018173158*PED2030-09-17Pediatric extension84e616aacf4f…
2026-09-14 22:38:342026-08N022287-00192331032032-03-05U-18052016-02-1184e616aacf4f…
2026-09-14 22:38:342026-08N022287-00284611872026-01-17Drug product84e616aacf4f…
2026-09-14 22:38:342026-08N022287-00292380292026-01-17Drug product2016-02-1184e616aacf4f…
2026-09-14 22:38:342026-08N022287-00290119262026-02-24Drug product2015-05-0184e616aacf4f…
2026-09-14 22:38:342026-08N022287-0028461187*PED2026-07-17Pediatric extension84e616aacf4f…
2026-09-14 22:38:342026-08N022287-00277907552026-08-02Drug product84e616aacf4f…
2026-09-14 22:38:342026-08N022287-00281056262026-09-27Drug product84e616aacf4f…
2026-09-14 22:38:342026-08N022287-0027790755*PED2027-02-02Pediatric extension84e616aacf4f…
2026-09-14 22:38:342026-08N022287-0028105626*PED2027-03-27Pediatric extension84e616aacf4f…
2026-09-14 22:38:342026-08N022287-00288712732028-01-11Drug product2014-12-0184e616aacf4f…
2026-09-14 22:38:342026-08N022287-00281731582030-03-17U-95184e616aacf4f…
2026-09-14 22:38:342026-08N022287-00281731582030-03-17U-95084e616aacf4f…
2026-09-14 22:38:342026-08N022287-00281731582030-03-17U-94984e616aacf4f…
2026-09-14 22:38:342026-08N022287-0028173158*PED2030-09-17Pediatric extension84e616aacf4f…
2026-09-14 22:38:342026-08N022287-00292331032032-03-05U-18052016-02-1184e616aacf4f…
2026-08-18 06:07:402026-07N022287-00184611872026-01-17Drug productcaaa826d4ba7…
2026-08-18 06:07:402026-07N022287-00192380292026-01-17Drug product2016-02-11caaa826d4ba7…
2026-08-18 06:07:402026-07N022287-00190119262026-02-24Drug product2015-05-01caaa826d4ba7…
2026-08-18 06:07:402026-07N022287-0018461187*PED2026-07-17Pediatric extensioncaaa826d4ba7…
2026-08-18 06:07:402026-07N022287-00177907552026-08-02Drug product2010-09-29caaa826d4ba7…
2026-08-18 06:07:402026-07N022287-00181056262026-09-27Drug product2012-02-28caaa826d4ba7…
2026-08-18 06:07:402026-07N022287-0017790755*PED2027-02-02Pediatric extensioncaaa826d4ba7…
2026-08-18 06:07:402026-07N022287-0018105626*PED2027-03-27Pediatric extensioncaaa826d4ba7…
2026-08-18 06:07:402026-07N022287-00188712732028-01-11Drug product2014-12-01caaa826d4ba7…
2026-08-18 06:07:402026-07N022287-00181731582030-03-17U-9512012-06-01caaa826d4ba7…
2026-08-18 06:07:402026-07N022287-00181731582030-03-17U-9492012-06-01caaa826d4ba7…
2026-08-18 06:07:402026-07N022287-00181731582030-03-17U-9502012-06-01caaa826d4ba7…

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2019-12-13 00:20 UTC2019-12N022287-001NPP2019-07-0874a2ff9319b5…
2019-12-13 00:20 UTC2019-12N022287-001NPP2019-07-0874a2ff9319b5…
2019-12-13 00:20 UTC2019-12N022287-001NPP2019-07-0874a2ff9319b5…
2019-12-13 00:20 UTC2019-12N022287-002NPP2019-07-0874a2ff9319b5…
2019-12-13 00:20 UTC2019-12N022287-002NPP2019-07-0874a2ff9319b5…
2019-12-13 00:20 UTC2019-12N022287-002NPP2019-07-0874a2ff9319b5…
2019-12-14 00:12 UTC2019-12N022287-001NPP2019-07-083f01610625f2…
2019-12-14 00:12 UTC2019-12N022287-001NPP2019-07-083f01610625f2…
2019-12-14 00:12 UTC2019-12N022287-001NPP2019-07-083f01610625f2…
2019-12-14 00:12 UTC2019-12N022287-002NPP2019-07-083f01610625f2…
2019-12-14 00:12 UTC2019-12N022287-002NPP2019-07-083f01610625f2…
2019-12-14 00:12 UTC2019-12N022287-002NPP2019-07-083f01610625f2…
2019-09-15 20:21 UTC2019-09N022287-001NPP2019-07-08b00525d2431f…
2019-09-15 20:21 UTC2019-09N022287-001NPP2019-07-08b00525d2431f…
2019-09-15 20:21 UTC2019-09N022287-001NPP2019-07-08b00525d2431f…
2019-09-15 20:21 UTC2019-09N022287-002NPP2019-07-08b00525d2431f…
2019-09-15 20:21 UTC2019-09N022287-002NPP2019-07-08b00525d2431f…
2019-09-15 20:21 UTC2019-09N022287-002NPP2019-07-08b00525d2431f…
2019-07-19 19:46 UTC2019-07N022287-001NPP2019-07-08ea99ee380514…
2019-07-19 19:46 UTC2019-07N022287-001NPP2019-07-08ea99ee380514…
2019-07-19 19:46 UTC2019-07N022287-001NPP2019-07-08ea99ee380514…
2019-07-19 19:46 UTC2019-07N022287-002NPP2019-07-08ea99ee380514…
2019-07-19 19:46 UTC2019-07N022287-002NPP2019-07-08ea99ee380514…
2019-07-19 19:46 UTC2019-07N022287-002NPP2019-07-08ea99ee380514…

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 UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
UYE4T5I70XInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
833204Internal RxNorm lookup
833213Internal RxNorm lookup
902624Internal RxNorm lookup
902626Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
9819f033-3bbe-442e-8e92-45fec77b237dAvailable on FDA.report

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 [CARDINAL HEALTH]3
dexlansoprazoleACTIVE MOIETYUYE4T5I70XDEXILANT (DEXLANSOPRAZOLE) CAPSULE, DELAYED RELEASE [CARDINAL HEALTH]3
aluminum oxideINACTIVE INGREDIENTLMI26O6933DEXILANT (DEXLANSOPRAZOLE) CAPSULE, DELAYED RELEASE [CARDINAL HEALTH]3
carrageenanINACTIVE INGREDIENT5C69YCD2YJDEXILANT (DEXLANSOPRAZOLE) CAPSULE, DELAYED RELEASE [CARDINAL HEALTH]3
FD&C Blue No. 2INACTIVE INGREDIENTL06K8R7DQKDEXILANT (DEXLANSOPRAZOLE) CAPSULE, DELAYED RELEASE [CARDINAL HEALTH]3
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PDEXILANT (DEXLANSOPRAZOLE) CAPSULE, DELAYED RELEASE [CARDINAL HEALTH]3
hydroxypropyl cellulose, low substitutedINACTIVE INGREDIENT2165RE0K14DEXILANT (DEXLANSOPRAZOLE) CAPSULE, DELAYED RELEASE [CARDINAL HEALTH]3
HYPROMELLOSE 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6DEXILANT (DEXLANSOPRAZOLE) CAPSULE, DELAYED RELEASE [CARDINAL HEALTH]3
magnesium carbonateINACTIVE INGREDIENT0E53J927NADEXILANT (DEXLANSOPRAZOLE) CAPSULE, DELAYED RELEASE [CARDINAL HEALTH]3
Methacrylic Acid - Ethyl Acrylate Copolymer (1:1) Type AINACTIVE INGREDIENTNX76LV5T8JDEXILANT (DEXLANSOPRAZOLE) CAPSULE, DELAYED RELEASE [CARDINAL HEALTH]3
Methacrylic Acid - Methyl Methacrylate Copolymer (1:1)INACTIVE INGREDIENT74G4R6TH13DEXILANT (DEXLANSOPRAZOLE) CAPSULE, DELAYED RELEASE [CARDINAL HEALTH]3
Methacrylic Acid - Methyl Methacrylate Copolymer (1:2)INACTIVE INGREDIENT5KY68S2577DEXILANT (DEXLANSOPRAZOLE) CAPSULE, DELAYED RELEASE [CARDINAL HEALTH]3
polyethylene glycol 8000INACTIVE INGREDIENTQ662QK8M3BDEXILANT (DEXLANSOPRAZOLE) CAPSULE, DELAYED RELEASE [CARDINAL HEALTH]3
polysorbate 80INACTIVE INGREDIENT6OZP39ZG8HDEXILANT (DEXLANSOPRAZOLE) CAPSULE, DELAYED RELEASE [CARDINAL HEALTH]3
potassium chlorideINACTIVE INGREDIENT660YQ98I10DEXILANT (DEXLANSOPRAZOLE) CAPSULE, DELAYED RELEASE [CARDINAL HEALTH]3
silicon dioxideINACTIVE INGREDIENTETJ7Z6XBU4DEXILANT (DEXLANSOPRAZOLE) CAPSULE, DELAYED RELEASE [CARDINAL HEALTH]3
sucroseINACTIVE INGREDIENTC151H8M554DEXILANT (DEXLANSOPRAZOLE) CAPSULE, DELAYED RELEASE [CARDINAL HEALTH]3
talcINACTIVE INGREDIENT7SEV7J4R1UDEXILANT (DEXLANSOPRAZOLE) CAPSULE, DELAYED RELEASE [CARDINAL HEALTH]3
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPDEXILANT (DEXLANSOPRAZOLE) CAPSULE, DELAYED RELEASE [CARDINAL HEALTH]3
triethyl citrateINACTIVE INGREDIENT8Z96QXD6UMDEXILANT (DEXLANSOPRAZOLE) CAPSULE, DELAYED RELEASE [CARDINAL HEALTH]3
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

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DexilantDEXLANSOPRAZOLETakeda Pharmaceuticals America, Inc.9819f033-3bbe-442e-8e92-45fec77b237d2025-02-17Warnings, Adverse reactionsExact identifier
application applno (NDA): 022287
application number: NDA022287
ndc (product): 64764-175
Dexlansoprazole delayed releaseDEXLANSOPRAZOLEA-S Medication Solutions7c7698da-3cda-4301-ae93-02fb64b9c90d2023-11-22Warnings, Adverse reactionsExact identifier
application applno (NDA): 022287
application number: NDA022287

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