FDA.reportPublic FDA data

ONYDA XR

Product NDC
24478-148
11-digit product format
244780148
Labeler code
24478
Product ID
24478-148_00de799f-c9cb-42b7-8471-5bde35108200
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clonidine hydrochloride
Dosage form
SUSPENSION, EXTENDED RELEASE
Route
ORAL
Labeler
NextWave Pharmaceuticals, Inc
Application
NDA217645
Marketing category
NDA
Marketing start
2024-08-13
Substance
CLONIDINE HYDROCHLORIDE
Active strength
.1 mg/mL
Pharmacologic classes
Adrenergic alpha2-Agonists [MoA], Central alpha-2 Adrenergic Agonist [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CLONIDINE HYDROCHLORIDE.1 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiW76I6XXF06
Rxcui2690727, 2690735

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
45c8ba14-e378-46f0-b21f-1aad8e08c613Product name120250221
6920b0ed-30bc-b127-73e1-0713049bd41eProduct name920190618
a90f088a-9578-47a2-8f6e-0a9d32aafec6Product name120181030
f6c90bdc-1674-455a-aadd-1b1b59e5edebProduct name220181030
6920b0ed-30bc-b127-73e1-0713049bd41eProduct name520171212
48f5a4fd-7cdc-dc04-771d-ce7a47326789Product name220150123
624cf764-e200-44b5-83c2-84526255adb5Product name120150107
47972e1b-c905-eeee-5e77-eb4538ad833cProduct name120140508
7667d8e2-e5be-36e1-4de7-231aa7fdaf5cProduct name120140508
f1ec5c2f-d01e-a277-5826-c7eba86ed99bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
24478-148-01ONYDA XR7 mL in 1 BOTTLESUSPENSION, EXTENDED RELEASE714
24478-148-02ONYDA XR120 mL in 1 BOTTLESUSPENSION, EXTENDED RELEASE12014
24478-148-03ONYDA XR30 mL in 1 BOTTLESUSPENSION, EXTENDED RELEASE3014
24478-148-04ONYDA XR60 mL in 1 BOTTLESUSPENSION, EXTENDED RELEASE6014

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
24478-148-01ML - Milliliter24478-14853b536bf-275b-4a1b-a969-e474e8be189c12024-09-09
24478-148-03ML - Milliliter24478-1480c7a82c0-b377-4246-8187-3177489f749012024-10-04
24478-148-04ML - Milliliter24478-148c9ecd569-98c8-49f3-aad1-0bb01c44968412024-10-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
24478-148ONYDA XR (CLONIDINE HYDROCHLORIDE) SUSPENSION, EXTENDED RELEASE [NEXTWAVE PHARMACEUTICALS, INC]14Current NDC, 4 package rows20250501_4a15c850-9da5-4bdc-a34d-7f740a6149b7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2690727cloNIDine hydrochloride 0.1 MG/mL 24HR Extended Release SuspensionPSN4a15c850-9da5-4bdc-a34d-7f740a6149b714
2690735ONYDA XR 0.1 MG/mL 24HR Extended Release SuspensionPSN4a15c850-9da5-4bdc-a34d-7f740a6149b714
269073524 HR clonidine hydrochloride 0.1 MG/ML Extended Release Suspension [Onyda]SBD4a15c850-9da5-4bdc-a34d-7f740a6149b714
269072724 HR clonidine hydrochloride 0.1 MG/ML Extended Release SuspensionSCD4a15c850-9da5-4bdc-a34d-7f740a6149b714
2690727clonidine hydrochloride 0.1 MG/mL 24 HR Extended Release SuspensionSY4a15c850-9da5-4bdc-a34d-7f740a6149b714
2690735Onyda XR 0.1 MG/mL 24 HR Extended Release SuspensionSY4a15c850-9da5-4bdc-a34d-7f740a6149b714

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
24478-148-01244780148017 mL in 1 BOTTLE (24478-148-01) 7 ml2024-08-13YesNoCurrent
24478-148-0224478014802120 mL in 1 BOTTLE120 mlHistorical
24478-148-032447801480330 mL in 1 BOTTLE (24478-148-03) 30 ml2024-08-13NoNoCurrent
24478-148-042447801480460 mL in 1 BOTTLE60 mlHistorical