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

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 Identifiers#

Field, Values table
FieldValues
UniiQ3OKS62Q6X
Rxcui2675280, 2675286

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

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 pouch2024-02-09NoNoHistorical
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 pouch2024-02-09NoNoHistorical