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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	24478-148	24478-148-02	D	Discontinued by firm		2026-08-03
excluded package	package	24478-148	24478-148-04	D	Discontinued by firm		2026-08-03

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 10 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Package NDC, Snapshot table
Captured / source date	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	24478-148-04	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	24478-148-02	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	24478-148-04	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	24478-148-02	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	24478-148-02	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	24478-148-04	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	24478-148-02	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	24478-148-04	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	24478-148-02	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	24478-148-04	`cfe11265f3b6…`	`090c488252e2…`

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-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N217645-001	ONYDA XR	CLONIDINE HYDROCHLORIDE	0.1MG/ML	SUSPENSION, EXTENDED RELEASE / ORAL		RLD, RS	2024-05-24

Orange Book patents#

Current patent rows page 1 of 1 · 3 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N217645-001	8062667	2029-03-29		Drug product	2024-06-12
N217645-001	11918689	2041-07-28	U-3944	Drug product	2024-06-12
N217645-001	12576032	2041-07-28	U-2357		2026-03-27

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
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N217645-001	ONYDA XR	0.1MG/ML	SUSPENSION, EXTENDED RELEASE / ORAL	RLD, RS	2024-05-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N217645-001	ONYDA XR	0.1MG/ML	SUSPENSION, EXTENDED RELEASE / ORAL	RLD, RS	2024-05-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N217645-001	ONYDA XR	0.1MG/ML	SUSPENSION, EXTENDED RELEASE / ORAL	RLD, RS	2024-05-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N217645-001	ONYDA XR	0.1MG/ML	SUSPENSION, EXTENDED RELEASE / ORAL	RLD, RS	2024-05-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N217645-001	ONYDA XR	0.1MG/ML	SUSPENSION, EXTENDED RELEASE / ORAL	RLD, RS	2024-05-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N217645-001	ONYDA XR	0.1MG/ML	SUSPENSION, EXTENDED RELEASE / ORAL	RLD, RS	2024-05-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N217645-001	ONYDA XR	0.1MG/ML	SUSPENSION, EXTENDED RELEASE / ORAL	RLD, RS	2024-05-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N217645-001	ONYDA XR	0.1MG/ML	SUSPENSION, EXTENDED RELEASE / ORAL	RLD, RS	2024-05-24	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N217645-001	ONYDA XR	0.1MG/ML	SUSPENSION, EXTENDED RELEASE / ORAL	RLD, RS	2024-05-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N217645-001	ONYDA XR	0.1MG/ML	SUSPENSION, EXTENDED RELEASE / ORAL	RLD, RS	2024-05-24	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N217645-001	ONYDA XR	0.1MG/ML	SUSPENSION, EXTENDED RELEASE / ORAL	RLD, RS	2024-05-24	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N217645-001	ONYDA XR	0.1MG/ML	SUSPENSION, EXTENDED RELEASE / ORAL	RLD, RS	2024-05-24	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N217645-001	ONYDA XR	0.1MG/ML	SUSPENSION, EXTENDED RELEASE / ORAL	RLD, RS	2024-05-24	`1e350fbaab3a…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N217645-001	ONYDA XR	0.1MG/ML	SUSPENSION, EXTENDED RELEASE / ORAL	RLD, RS	2024-05-24	`a50c72e98297…`

Observed Orange Book patent history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N217645-001	8062667	2029-03-29		Drug product	2024-06-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217645-001	11918689	2041-07-28	U-3944	Drug product	2024-06-12	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N217645-001	8062667	2029-03-29		Drug product	2024-06-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N217645-001	11918689	2041-07-28	U-3944	Drug product	2024-06-12	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N217645-001	8062667	2029-03-29		Drug product	2024-06-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N217645-001	11918689	2041-07-28	U-3944	Drug product	2024-06-12	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N217645-001	8062667	2029-03-29		Drug product	2024-06-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N217645-001	11918689	2041-07-28	U-3944	Drug product	2024-06-12	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N217645-001	8062667	2029-03-29		Drug product	2024-06-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N217645-001	11918689	2041-07-28	U-3944	Drug product	2024-06-12	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N217645-001	8062667	2029-03-29		Drug product	2024-06-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N217645-001	11918689	2041-07-28	U-3944	Drug product	2024-06-12	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N217645-001	8062667	2029-03-29		Drug product	2024-06-12	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N217645-001	11918689	2041-07-28	U-3944	Drug product	2024-06-12	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N217645-001	8062667	2029-03-29		Drug product	2024-06-12	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N217645-001	11918689	2041-07-28	U-3944	Drug product	2024-06-12	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N217645-001	8062667	2029-03-29		Drug product	2024-06-12	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N217645-001	11918689	2041-07-28	U-3944	Drug product	2024-06-12	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N217645-001	8062667	2029-03-29		Drug product	2024-06-12	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N217645-001	11918689	2041-07-28	U-3944	Drug product	2024-06-12	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N217645-001	8062667	2029-03-29		Drug product	2024-06-12	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N217645-001	11918689	2041-07-28	U-3944	Drug product	2024-06-12	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N217645-001	8062667	2029-03-29		Drug product	2024-06-12	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N217645-001	11918689	2041-07-28	U-3944	Drug product	2024-06-12	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N217645-001	8062667	2029-03-29		Drug product	2024-06-12	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N217645-001	11918689	2041-07-28	U-3944	Drug product	2024-06-12	`1e350fbaab3a…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N217645-001	8062667	2029-03-29		Drug product	2024-06-12	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N217645-001	11918689	2041-07-28	U-3944	Drug product	2024-06-12	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N217645-001	12576032	2041-07-28	U-2357		2026-03-27	`a50c72e98297…`

Additional Listing Data#

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

Active Ingredients#

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

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
W76I6XXF06	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
2690727	Internal RxNorm lookup
2690735	Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
4a15c850-9da5-4bdc-a34d-7f740a6149b7	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
45c8ba14-e378-46f0-b21f-1aad8e08c613	Product name	1	20250221
6920b0ed-30bc-b127-73e1-0713049bd41e	Product name	9	20190618
a90f088a-9578-47a2-8f6e-0a9d32aafec6	Product name	1	20181030
f6c90bdc-1674-455a-aadd-1b1b59e5edeb	Product name	2	20181030
6920b0ed-30bc-b127-73e1-0713049bd41e	Product name	5	20171212
48f5a4fd-7cdc-dc04-771d-ce7a47326789	Product name	2	20150123
624cf764-e200-44b5-83c2-84526255adb5	Product name	1	20150107
47972e1b-c905-eeee-5e77-eb4538ad833c	Product name	1	20140508
7667d8e2-e5be-36e1-4de7-231aa7fdaf5c	Product name	1	20140508
f1ec5c2f-d01e-a277-5826-c7eba86ed99b	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
24478-148-01	ONYDA XR	7 mL in 1 BOTTLE	SUSPENSION, EXTENDED RELEASE	7	14
24478-148-02	ONYDA XR	120 mL in 1 BOTTLE	SUSPENSION, EXTENDED RELEASE	120	14
24478-148-03	ONYDA XR	30 mL in 1 BOTTLE	SUSPENSION, EXTENDED RELEASE	30	14
24478-148-04	ONYDA XR	60 mL in 1 BOTTLE	SUSPENSION, EXTENDED RELEASE	60	14

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
24478-148-01	ML - Milliliter	24478-148	53b536bf-275b-4a1b-a969-e474e8be189c	1	2024-09-09
24478-148-03	ML - Milliliter	24478-148	0c7a82c0-b377-4246-8187-3177489f7490	1	2024-10-04
24478-148-04	ML - Milliliter	24478-148	c9ecd569-98c8-49f3-aad1-0bb01c449684	1	2024-10-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
24478-148	ONYDA XR (CLONIDINE HYDROCHLORIDE) SUSPENSION, EXTENDED RELEASE [NEXTWAVE PHARMACEUTICALS, INC]	14	Current NDC, 4 package rows	20250501_4a15c850-9da5-4bdc-a34d-7f740a6149b7.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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ONYDA XR	CLONIDINE HYDROCHLORIDE	NextWave Pharmaceuticals, Inc	4a15c850-9da5-4bdc-a34d-7f740a6149b7	2025-04-11	Warnings, Adverse reactions	Exact identifier application applno (NDA): 217645 application number: NDA217645 ndc (product): 24478-148

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
W76I6XXF06	CLONIDINE HYDROCHLORIDE	4205-91-8	CLONIDINE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2690727	cloNIDine hydrochloride 0.1 MG/mL 24HR Extended Release Suspension	PSN	4a15c850-9da5-4bdc-a34d-7f740a6149b7	14
2690735	ONYDA XR 0.1 MG/mL 24HR Extended Release Suspension	PSN	4a15c850-9da5-4bdc-a34d-7f740a6149b7	14
2690735	24 HR clonidine hydrochloride 0.1 MG/ML Extended Release Suspension [Onyda]	SBD	4a15c850-9da5-4bdc-a34d-7f740a6149b7	14
2690727	24 HR clonidine hydrochloride 0.1 MG/ML Extended Release Suspension	SCD	4a15c850-9da5-4bdc-a34d-7f740a6149b7	14
2690727	clonidine hydrochloride 0.1 MG/mL 24 HR Extended Release Suspension	SY	4a15c850-9da5-4bdc-a34d-7f740a6149b7	14
2690735	Onyda XR 0.1 MG/mL 24 HR Extended Release Suspension	SY	4a15c850-9da5-4bdc-a34d-7f740a6149b7	14

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
24478-148-01	24478014801	7 mL in 1 BOTTLE (24478-148-01)	7 ml	2024-08-13	Yes	No	Current
24478-148-02	24478014802	120 mL in 1 BOTTLE	120 ml				Historical
24478-148-03	24478014803	30 mL in 1 BOTTLE (24478-148-03)	30 ml	2024-08-13	No	No	Current
24478-148-04	24478014804	60 mL in 1 BOTTLE	60 ml				Historical