FDA.reportPublic FDA data

Eohilia

Product NDC
64764-105
11-digit product format
647640105
Labeler code
64764
Product ID
64764-105_6b8f012a-d7af-4200-a5b8-5a56f6962ccd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Budesonide
Dosage form
SUSPENSION
Route
ORAL
Labeler
TAKEDA PHARMACEUTICALS AMERICA, INC.
Application
NDA213976
Marketing category
NDA
Marketing start
2024-02-09
Substance
BUDESONIDE
Active strength
2 mg/10mL
Pharmacologic classes
Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
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 1.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N213976-001EOHILIABUDESONIDE2MG/10MLSUSPENSION / ORALRLD, RS2024-02-09

Orange Book patents#

Current patent rows page 1 of 1 · 12 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N213976-001111978222026-11-09Drug product2024-03-04
N213976-001114132962026-11-09Drug product2024-03-04
N213976-00184972582026-11-09U-38202024-03-04
N213976-00186795452026-11-09Drug product2024-03-04
N213976-00189752432026-11-09U-38202024-03-04
N213976-00191198632026-11-09U-38202024-03-04
N213976-001113578592028-11-12U-38202024-03-04
N213976-001102930522028-11-22Drug product2024-03-04
N213976-00190503682029-08-01Drug product2024-03-04
N213976-00183241922029-08-03U-38202024-03-04
N213976-001112600642039-01-10Drug product2024-03-04
N213976-001115649342039-01-10U-38202024-03-04

Orange Book exclusivity#

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

Application-product, Exclusivity code, Expiration table
Application-productExclusivity codeExpiration
N213976-001NP2027-02-09
N213976-001ODE-4662031-02-09

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N213976-001EOHILIA2MG/10MLSUSPENSION / ORALRLD, RS2024-02-09011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N213976-001EOHILIA2MG/10MLSUSPENSION / ORALRLD, RS2024-02-0931067a03dcf5…
2025-08-23 18:47 UTC2025-08N213976-001EOHILIA2MG/10MLSUSPENSION / ORALRLD, RS2024-02-096a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N213976-001EOHILIA2MG/10MLSUSPENSION / ORALRLD, RS2024-02-09fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N213976-001EOHILIA2MG/10MLSUSPENSION / ORALRLD, RS2024-02-09b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N213976-001EOHILIA2MG/10MLSUSPENSION / ORALRLD, RS2024-02-0903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N213976-001EOHILIA2MG/10MLSUSPENSION / ORALRLD, RS2024-02-092680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N213976-001EOHILIA2MG/10MLSUSPENSION / ORALRLD, RS2024-02-095bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N213976-001EOHILIA2MG/10MLSUSPENSION / ORALRLD, RS2024-02-09d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N213976-001EOHILIA2MG/10MLSUSPENSION / ORALRLD, RS2024-02-09d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N213976-001EOHILIA2MG/10MLSUSPENSION / ORALRLD, RS2024-02-0979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N213976-001EOHILIA2MG/10MLSUSPENSION / ORALRLD, RS2024-02-09301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N213976-001EOHILIA2MG/10MLSUSPENSION / ORALRLD, RS2024-02-091e350fbaab3a…
2024-05-31 18:47 UTC2024-05N213976-001EOHILIA2MG/10MLSUSPENSION / ORALRLD, RS2024-02-098072bd15b7f6…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N213976-001EOHILIA2MG/10MLSUSPENSION / ORALRLD, RS2024-02-096a51e52b5d6a…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N213976-001EOHILIA2MG/10MLSUSPENSION / ORALRLD, RS2024-02-09a50c72e98297…

Observed Orange Book patent history#

Patent history page 1 of 5 · 192 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-02-19 14:30 UTC2026-02N213976-001111978222026-11-09Drug product2024-03-04011fe1cb6892…
2026-02-19 14:30 UTC2026-02N213976-001114132962026-11-09Drug product2024-03-04011fe1cb6892…
2026-02-19 14:30 UTC2026-02N213976-00184972582026-11-09U-38202024-03-04011fe1cb6892…
2026-02-19 14:30 UTC2026-02N213976-00186795452026-11-09Drug product2024-03-04011fe1cb6892…
2026-02-19 14:30 UTC2026-02N213976-00189752432026-11-09U-38202024-03-04011fe1cb6892…
2026-02-19 14:30 UTC2026-02N213976-00191198632026-11-09U-38202024-03-04011fe1cb6892…
2026-02-19 14:30 UTC2026-02N213976-001113578592028-11-12U-38202024-03-04011fe1cb6892…
2026-02-19 14:30 UTC2026-02N213976-001102930522028-11-22Drug product2024-03-04011fe1cb6892…
2026-02-19 14:30 UTC2026-02N213976-00190503682029-08-01Drug product2024-03-04011fe1cb6892…
2026-02-19 14:30 UTC2026-02N213976-00183241922029-08-03U-38202024-03-04011fe1cb6892…
2026-02-19 14:30 UTC2026-02N213976-001112600642039-01-10Drug product2024-03-04011fe1cb6892…
2026-02-19 14:30 UTC2026-02N213976-001115649342039-01-10U-38202024-03-04011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N213976-001111978222026-11-09Drug product2024-03-0431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N213976-001114132962026-11-09Drug product2024-03-0431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N213976-00184972582026-11-09U-38202024-03-0431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N213976-00186795452026-11-09Drug product2024-03-0431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N213976-00189752432026-11-09U-38202024-03-0431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N213976-00191198632026-11-09U-38202024-03-0431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N213976-001113578592028-11-12U-38202024-03-0431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N213976-001102930522028-11-22Drug product2024-03-0431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N213976-00190503682029-08-01Drug product2024-03-0431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N213976-00183241922029-08-03U-38202024-03-0431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N213976-001112600642039-01-10Drug product2024-03-0431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N213976-001115649342039-01-10U-38202024-03-0431067a03dcf5…
2025-08-23 18:47 UTC2025-08N213976-001111978222026-11-09Drug product2024-03-046a471c1ec25d…
2025-08-23 18:47 UTC2025-08N213976-001114132962026-11-09Drug product2024-03-046a471c1ec25d…
2025-08-23 18:47 UTC2025-08N213976-00184972582026-11-09U-38202024-03-046a471c1ec25d…
2025-08-23 18:47 UTC2025-08N213976-00186795452026-11-09Drug product2024-03-046a471c1ec25d…
2025-08-23 18:47 UTC2025-08N213976-00189752432026-11-09U-38202024-03-046a471c1ec25d…
2025-08-23 18:47 UTC2025-08N213976-00191198632026-11-09U-38202024-03-046a471c1ec25d…
2025-08-23 18:47 UTC2025-08N213976-001113578592028-11-12U-38202024-03-046a471c1ec25d…
2025-08-23 18:47 UTC2025-08N213976-001102930522028-11-22Drug product2024-03-046a471c1ec25d…
2025-08-23 18:47 UTC2025-08N213976-00190503682029-08-01Drug product2024-03-046a471c1ec25d…
2025-08-23 18:47 UTC2025-08N213976-00183241922029-08-03U-38202024-03-046a471c1ec25d…
2025-08-23 18:47 UTC2025-08N213976-001112600642039-01-10Drug product2024-03-046a471c1ec25d…
2025-08-23 18:47 UTC2025-08N213976-001115649342039-01-10U-38202024-03-046a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N213976-001111978222026-11-09Drug product2024-03-04fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N213976-001114132962026-11-09Drug product2024-03-04fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N213976-00184972582026-11-09U-38202024-03-04fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N213976-00186795452026-11-09Drug product2024-03-04fd3edfee7708…

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2026-02-19 14:30 UTC2026-02N213976-001NP2027-02-09011fe1cb6892…
2026-02-19 14:30 UTC2026-02N213976-001ODE-4662031-02-09011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N213976-001NP2027-02-0931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N213976-001ODE-4662031-02-0931067a03dcf5…
2025-08-23 18:47 UTC2025-08N213976-001NP2027-02-096a471c1ec25d…
2025-08-23 18:47 UTC2025-08N213976-001ODE-4662031-02-096a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N213976-001NP2027-02-09fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N213976-001ODE-4662031-02-09fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N213976-001NP2027-02-09b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N213976-001ODE-4662031-02-09b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N213976-001NP2027-02-0903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N213976-001ODE-4662031-02-0903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N213976-001NP2027-02-092680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N213976-001ODE-4662031-02-092680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N213976-001NP2027-02-095bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N213976-001ODE-4662031-02-095bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N213976-001NP2027-02-09d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N213976-001ODE-4662031-02-09d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N213976-001NP2027-02-09d06236e962d9…
2024-10-29 15:01 UTC2024-10N213976-001ODE-4662031-02-09d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N213976-001NP2027-02-0979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N213976-001ODE-4662031-02-0979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N213976-001NP2027-02-09301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N213976-001ODE-4662031-02-09301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N213976-001NP2027-02-091e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N213976-001ODE-4662031-02-091e350fbaab3a…
2024-05-31 18:47 UTC2024-05N213976-001NP2027-02-098072bd15b7f6…
2024-05-31 18:47 UTC2024-05N213976-001ODE-4662031-02-098072bd15b7f6…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N213976-001NP2027-02-096a51e52b5d6a…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N213976-001NP2027-02-09a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N213976-001ODE-4662031-02-09a50c72e98297…

Additional Listing Data#

Finished product
Yes
Brand name base
Eohilia
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BUDESONIDE2 mg/10mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
Q3OKS62Q6XInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2675280Internal RxNorm lookup
2675286Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
56f2023a-69b2-4470-b4ad-af7ec1be527aAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
7816cdf6-b925-4282-bedd-11ae25d518a1Product name120250116
d17a61d0-e77b-4bcb-ad22-343ff1a3ef4dProduct name220240424
9ab9f611-cedd-47ea-a83c-0489c8c04fc6Product name120231006
cb89b86a-369e-4204-8910-ae797c503af3Product name120230706
c76bcd0f-25eb-471e-b970-1956c95c26c5Product name120230425
a03aea00-1d8b-bfad-a82e-f52f68676f63Product name220221216
54a29484-7dde-4771-9547-005149321621Product name120220720
793b53dd-c0ea-da17-9ac0-fb5c4a6e0743Product name520211018
218c043e-94e5-4e66-a363-d0d446485bc6Product name220210512
7d8c8d5a-f174-4e6b-97b1-6fd615c5df9aProduct name120210204
5e2e25b6-cb6b-8e81-afe3-62c3e2cd56c7Product name920210127
da63bc8c-2e89-4044-89d6-1facbff5474eProduct name120200121
d4880ace-a516-8c47-8dfd-73a4ba5887d7Product name220180830
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
899766bc-33ce-8154-910d-12cb0889fb56Product name220150106

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
64764-105-00Eohilia10 in 1 CARTONSUSPENSION106
64764-105-01Eohilia10 mL in 1 POUCHSUSPENSION106
64764-105-10Eohilia10 mL in 1 POUCHSUSPENSION106
64764-105-60Eohilia60 in 1 CARTONSUSPENSION606

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
64764-105-00ML - Milliliter64764-1053ea9177d-5ed6-4452-ac3d-30f29e38c04212024-06-10
64764-105-10ML - Milliliter64764-105d6707200-65ac-4c20-bef2-685e144e3d4412024-03-12
64764-105-60ML - Milliliter64764-105dfab7f54-8d2d-4a30-84ad-5bca542a802712024-03-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64764-105EOHILIA (BUDESONIDE) SUSPENSION [TAKEDA PHARMACEUTICALS AMERICA, INC.]6Current NDC, 4 package rows20250206_56f2023a-69b2-4470-b4ad-af7ec1be527a.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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
EohiliaBUDESONIDETAKEDA PHARMACEUTICALS AMERICA, INC.56f2023a-69b2-4470-b4ad-af7ec1be527a2025-02-03Warnings, Adverse reactionsExact identifier
application applno (NDA): 213976
application number: NDA213976
ndc (product): 64764-105

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2675280budesonide 2 MG in 10 mL Oral SuspensionPSN56f2023a-69b2-4470-b4ad-af7ec1be527a6
2675286Eohilia 2 MG in 10 mL Oral SuspensionPSN56f2023a-69b2-4470-b4ad-af7ec1be527a6
2675286budesonide 0.2 MG/ML Oral Suspension [Eohilia]SBD56f2023a-69b2-4470-b4ad-af7ec1be527a6
2675280budesonide 0.2 MG/ML Oral SuspensionSCD56f2023a-69b2-4470-b4ad-af7ec1be527a6
2675280budesonide 2 MG per 10 ML Oral SuspensionSY56f2023a-69b2-4470-b4ad-af7ec1be527a6
2675286Eohilia 0.2 MG/ML Oral SuspensionSY56f2023a-69b2-4470-b4ad-af7ec1be527a6
2675286Eohilia 2 MG per 10 ML Oral SuspensionSY56f2023a-69b2-4470-b4ad-af7ec1be527a6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
64764-105-006476401050010 POUCH in 1 CARTON (64764-105-00) / 10 mL in 1 POUCH (64764-105-01) 10 pouch2024-02-09NoNoCurrent
64764-105-016476401050110 mL in 1 POUCH10 mlHistorical
64764-105-106476401051010 mL in 1 POUCH10 mlHistorical
64764-105-606476401056060 POUCH in 1 CARTON (64764-105-60) / 10 mL in 1 POUCH (64764-105-10) 60 pouch2024-02-09NoNoCurrent