DYANAVEL XR

Product NDC: 24478-109
Requested package NDC: 24478-109-01
11-digit product format: 244780109
Labeler code: 24478
Product ID: 24478-109_32c90701-fe4a-4d5a-b3bb-e9ccf0416ece
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: amphetamine
Dosage form: TABLET, EXTENDED RELEASE
Route: ORAL
Labeler: NextWave Pharmaceuticals, Inc
Application: NDA210526
Marketing category: NDA
Marketing start: 2021-11-04
Substance: AMPHETAMINE
Active strength: 15 mg/1
Pharmacologic classes: Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]
DEA schedule: CII
NDC exclude flag: No
Listing certified through: 2027-12-31
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 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N210526-001	DYANAVEL XR 5	AMPHETAMINE; AMPHETAMINE ASPARTATE/DEXTROAMPHETAMINE SULFATE	4MG;EQ 1MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2021-11-04
N210526-002	DYANAVEL XR 10	AMPHETAMINE; AMPHETAMINE ASPARTATE/DEXTROAMPHETAMINE SULFATE	8MG;EQ 2MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2021-11-04
N210526-003	DYANAVEL XR 15	AMPHETAMINE; AMPHETAMINE ASPARTATE/DEXTROAMPHETAMINE SULFATE	12MG;EQ 3MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2021-11-04
N210526-004	DYANAVEL XR 20	AMPHETAMINE; AMPHETAMINE ASPARTATE/DEXTROAMPHETAMINE SULFATE	16MG;EQ 4MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2021-11-04

Orange Book patents#

Current patent rows page 1 of 1 · 20 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N210526-001	8337890	2027-03-15		Drug product	2021-11-22
N210526-001	8747902	2027-03-15		Drug product	2021-11-22
N210526-001	9675704	2027-03-15		Drug product	2021-11-22
N210526-001	11590081	2038-09-24	U-3538	Drug product	2023-03-08
N210526-001	12458592	2040-02-11	U-3538		2025-11-14
N210526-002	8337890	2027-03-15		Drug product	2021-11-22
N210526-002	8747902	2027-03-15		Drug product	2021-11-22
N210526-002	9675704	2027-03-15		Drug product	2021-11-22
N210526-002	11590081	2038-09-24	U-3538	Drug product	2023-03-08
N210526-002	12458592	2040-02-11	U-3538		2025-11-14
N210526-003	8337890	2027-03-15		Drug product	2021-11-22
N210526-003	8747902	2027-03-15		Drug product	2021-11-22
N210526-003	9675704	2027-03-15		Drug product	2021-11-22
N210526-003	11590081	2038-09-24	U-3538	Drug product	2023-03-08
N210526-003	12458592	2040-02-11	U-3538		2025-11-14
N210526-004	8337890	2027-03-15		Drug product	2021-11-22
N210526-004	8747902	2027-03-15		Drug product	2021-11-22
N210526-004	9675704	2027-03-15		Drug product	2021-11-22
N210526-004	11590081	2038-09-24	U-3538	Drug product	2023-03-08
N210526-004	12458592	2040-02-11	U-3538		2025-11-14

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 4 · 132 observed 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	N210526-001	DYANAVEL XR 5	4MG;EQ 1MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2021-11-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210526-002	DYANAVEL XR 10	8MG;EQ 2MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2021-11-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210526-003	DYANAVEL XR 15	12MG;EQ 3MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2021-11-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210526-004	DYANAVEL XR 20	16MG;EQ 4MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2021-11-04	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210526-001	DYANAVEL XR 5	4MG;EQ 1MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2021-11-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210526-002	DYANAVEL XR 10	8MG;EQ 2MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2021-11-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210526-003	DYANAVEL XR 15	12MG;EQ 3MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2021-11-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210526-004	DYANAVEL XR 20	16MG;EQ 4MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2021-11-04	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N210526-001	DYANAVEL XR 5	4MG;EQ 1MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2021-11-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N210526-002	DYANAVEL XR 10	8MG;EQ 2MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2021-11-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N210526-003	DYANAVEL XR 15	12MG;EQ 3MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2021-11-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N210526-004	DYANAVEL XR 20	16MG;EQ 4MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2021-11-04	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N210526-001	DYANAVEL XR 5	4MG;EQ 1MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2021-11-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N210526-002	DYANAVEL XR 10	8MG;EQ 2MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2021-11-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N210526-003	DYANAVEL XR 15	12MG;EQ 3MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2021-11-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N210526-004	DYANAVEL XR 20	16MG;EQ 4MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2021-11-04	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N210526-001	DYANAVEL XR 5	4MG;EQ 1MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2021-11-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N210526-002	DYANAVEL XR 10	8MG;EQ 2MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2021-11-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N210526-003	DYANAVEL XR 15	12MG;EQ 3MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2021-11-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N210526-004	DYANAVEL XR 20	16MG;EQ 4MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2021-11-04	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N210526-001	DYANAVEL XR 5	4MG;EQ 1MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2021-11-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N210526-002	DYANAVEL XR 10	8MG;EQ 2MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2021-11-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N210526-003	DYANAVEL XR 15	12MG;EQ 3MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2021-11-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N210526-004	DYANAVEL XR 20	16MG;EQ 4MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2021-11-04	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N210526-001	DYANAVEL XR 5	4MG;EQ 1MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2021-11-04	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N210526-002	DYANAVEL XR 10	8MG;EQ 2MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2021-11-04	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N210526-003	DYANAVEL XR 15	12MG;EQ 3MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2021-11-04	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N210526-004	DYANAVEL XR 20	16MG;EQ 4MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2021-11-04	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N210526-001	DYANAVEL XR 5	4MG;EQ 1MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2021-11-04	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N210526-002	DYANAVEL XR 10	8MG;EQ 2MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2021-11-04	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N210526-003	DYANAVEL XR 15	12MG;EQ 3MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2021-11-04	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N210526-004	DYANAVEL XR 20	16MG;EQ 4MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2021-11-04	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N210526-001	DYANAVEL XR 5	4MG;EQ 1MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2021-11-04	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N210526-002	DYANAVEL XR 10	8MG;EQ 2MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2021-11-04	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N210526-003	DYANAVEL XR 15	12MG;EQ 3MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2021-11-04	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N210526-004	DYANAVEL XR 20	16MG;EQ 4MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2021-11-04	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N210526-001	DYANAVEL XR 5	4MG;EQ 1MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2021-11-04	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N210526-002	DYANAVEL XR 10	8MG;EQ 2MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2021-11-04	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N210526-003	DYANAVEL XR 15	12MG;EQ 3MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2021-11-04	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N210526-004	DYANAVEL XR 20	16MG;EQ 4MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2021-11-04	`d06236e962d9…`

Observed Orange Book patent history#

Patent history page 1 of 13 · 500 observed states.

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	N210526-001	8337890	2027-03-15		Drug product	2021-11-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210526-001	8747902	2027-03-15		Drug product	2021-11-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210526-001	9675704	2027-03-15		Drug product	2021-11-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210526-001	11590081	2038-09-24	U-3538	Drug product	2023-03-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210526-001	12458592	2040-02-11	U-3538		2025-11-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210526-002	8337890	2027-03-15		Drug product	2021-11-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210526-002	8747902	2027-03-15		Drug product	2021-11-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210526-002	9675704	2027-03-15		Drug product	2021-11-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210526-002	11590081	2038-09-24	U-3538	Drug product	2023-03-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210526-002	12458592	2040-02-11	U-3538		2025-11-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210526-003	8337890	2027-03-15		Drug product	2021-11-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210526-003	8747902	2027-03-15		Drug product	2021-11-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210526-003	9675704	2027-03-15		Drug product	2021-11-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210526-003	11590081	2038-09-24	U-3538	Drug product	2023-03-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210526-003	12458592	2040-02-11	U-3538		2025-11-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210526-004	8337890	2027-03-15		Drug product	2021-11-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210526-004	8747902	2027-03-15		Drug product	2021-11-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210526-004	9675704	2027-03-15		Drug product	2021-11-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210526-004	11590081	2038-09-24	U-3538	Drug product	2023-03-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210526-004	12458592	2040-02-11	U-3538		2025-11-14	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210526-001	8337890	2027-03-15		Drug product	2021-11-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210526-001	8747902	2027-03-15		Drug product	2021-11-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210526-001	9675704	2027-03-15		Drug product	2021-11-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210526-001	11590081	2038-09-24	U-3538	Drug product	2023-03-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210526-001	12458592	2040-02-11	U-3538		2025-11-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210526-002	8337890	2027-03-15		Drug product	2021-11-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210526-002	8747902	2027-03-15		Drug product	2021-11-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210526-002	9675704	2027-03-15		Drug product	2021-11-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210526-002	11590081	2038-09-24	U-3538	Drug product	2023-03-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210526-002	12458592	2040-02-11	U-3538		2025-11-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210526-003	8337890	2027-03-15		Drug product	2021-11-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210526-003	8747902	2027-03-15		Drug product	2021-11-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210526-003	9675704	2027-03-15		Drug product	2021-11-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210526-003	11590081	2038-09-24	U-3538	Drug product	2023-03-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210526-003	12458592	2040-02-11	U-3538		2025-11-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210526-004	8337890	2027-03-15		Drug product	2021-11-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210526-004	8747902	2027-03-15		Drug product	2021-11-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210526-004	9675704	2027-03-15		Drug product	2021-11-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210526-004	11590081	2038-09-24	U-3538	Drug product	2023-03-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210526-004	12458592	2040-02-11	U-3538		2025-11-14	`31067a03dcf5…`

Additional Listing Data#

Finished product: Yes
Brand name base: DYANAVEL XR
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
AMPHETAMINE	15 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
CK833KGX7E	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 10 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1720586	Internal RxNorm lookup
1720592	Internal RxNorm lookup
2585460	Internal RxNorm lookup
2585461	Internal RxNorm lookup
2585462	Internal RxNorm lookup
2585465	Internal RxNorm lookup
2585468	Internal RxNorm lookup
2585471	Internal RxNorm lookup
2585473	Internal RxNorm lookup
2585476	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
ae304b29-0b40-40ec-ad0d-76b742d4a9b9	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
0f66b30d-6b15-4b2d-91a5-1531b9bb6d21	Product name	7	20250625
917bdf48-c3f5-4a58-ac8e-d2d94a9c1e2b	Product name	2	20250616
8b92ab59-8b26-4c89-a2d6-8d5140526ec6	Product name	3	20231213
4496d022-9224-4ee0-943a-50fbe6cd7123	Product name	2	20220901
2a7aa275-a4ca-44eb-971f-47427a374085	Product name	9	20220615
93730fbf-8b45-4623-b27d-cf03825d04b3	Product name	5	20220314
a90f088a-9578-47a2-8f6e-0a9d32aafec6	Product name	1	20181030
f6c90bdc-1674-455a-aadd-1b1b59e5edeb	Product name	2	20181030
57953747-955c-4dd8-9164-49d8ea877eae	Product name	1	20171113
fcc7ea58-a369-4e91-b092-5cde9ac2669f	Product name	1	20160224
f1ec5c2f-d01e-a277-5826-c7eba86ed99b	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
24478-109-01	DYANAVEL XR	30 in 1 BOTTLE	TABLET, EXTENDED RELEASE	30		14

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
24478-109-01	EA - Each	24478-109	61c048bf-81eb-4517-9b73-cab6f017706f	1	2022-08-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
24478-109	DYANAVEL XR (AMPHETAMINE) SUSPENSION, EXTENDED RELEASE DYANAVEL XR (AMPHETAMINE) TABLET, EXTENDED RELEASE [NEXTWAVE PHARMACEUTICALS, INC]	4	Current NDC, Legacy NDC, 1 package rows	20231027_ae304b29-0b40-40ec-ad0d-76b742d4a9b9.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
Dyanavel XR	AMPHETAMINE	NextWave Pharmaceuticals, Inc	ae304b29-0b40-40ec-ad0d-76b742d4a9b9	2026-02-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 210526 application number: NDA210526 ndc (package): 24478-109-01 ndc (product): 24478-109 ndc11 (package): 24478010901

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
CK833KGX7E	AMPHETAMINE	300-62-9	AMPHETAMINE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2585460	amphetamine 10 MG 24HR Extended Release Oral Tablet	PSN	ae304b29-0b40-40ec-ad0d-76b742d4a9b9	14
2585462	amphetamine 15 MG 24HR Extended Release Oral Tablet	PSN	ae304b29-0b40-40ec-ad0d-76b742d4a9b9	14
1720586	amphetamine 2.5 MG in 1 mL 24HR Extended Release Suspension	PSN	ae304b29-0b40-40ec-ad0d-76b742d4a9b9	14
2585468	amphetamine 20 MG 24HR Extended Release Oral Tablet	PSN	ae304b29-0b40-40ec-ad0d-76b742d4a9b9	14
2585473	amphetamine 5 MG 24HR Extended Release Oral Tablet	PSN	ae304b29-0b40-40ec-ad0d-76b742d4a9b9	14
2585461	Dyanavel XR 10 MG 24HR Extended Release Oral Tablet	PSN	ae304b29-0b40-40ec-ad0d-76b742d4a9b9	14
2585465	Dyanavel XR 15 MG 24HR Extended Release Oral Tablet	PSN	ae304b29-0b40-40ec-ad0d-76b742d4a9b9	14
1720592	Dyanavel XR 2.5 MG in 1 mL 24HR Extended Release Oral Suspension	PSN	ae304b29-0b40-40ec-ad0d-76b742d4a9b9	14
2585471	Dyanavel XR 20 MG 24HR Extended Release Oral Tablet	PSN	ae304b29-0b40-40ec-ad0d-76b742d4a9b9	14
2585476	Dyanavel XR 5 MG 24HR Extended Release Oral Tablet	PSN	ae304b29-0b40-40ec-ad0d-76b742d4a9b9	14
2585461	24 HR amphetamine 10 MG Extended Release Oral Tablet [Dyanavel]	SBD	ae304b29-0b40-40ec-ad0d-76b742d4a9b9	14
2585465	24 HR amphetamine 15 MG Extended Release Oral Tablet [Dyanavel]	SBD	ae304b29-0b40-40ec-ad0d-76b742d4a9b9	14
1720592	24 HR amphetamine 2.5 MG/ML Extended Release Suspension [Dyanavel]	SBD	ae304b29-0b40-40ec-ad0d-76b742d4a9b9	14
2585471	24 HR amphetamine 20 MG Extended Release Oral Tablet [Dyanavel]	SBD	ae304b29-0b40-40ec-ad0d-76b742d4a9b9	14
2585476	24 HR amphetamine 5 MG Extended Release Oral Tablet [Dyanavel]	SBD	ae304b29-0b40-40ec-ad0d-76b742d4a9b9	14
2585460	24 HR amphetamine 10 MG Extended Release Oral Tablet	SCD	ae304b29-0b40-40ec-ad0d-76b742d4a9b9	14
2585462	24 HR amphetamine 15 MG Extended Release Oral Tablet	SCD	ae304b29-0b40-40ec-ad0d-76b742d4a9b9	14
1720586	24 HR amphetamine 2.5 MG/ML Extended Release Suspension	SCD	ae304b29-0b40-40ec-ad0d-76b742d4a9b9	14
2585468	24 HR amphetamine 20 MG Extended Release Oral Tablet	SCD	ae304b29-0b40-40ec-ad0d-76b742d4a9b9	14
2585473	24 HR amphetamine 5 MG Extended Release Oral Tablet	SCD	ae304b29-0b40-40ec-ad0d-76b742d4a9b9	14
1720592	24 HR Dyanavel 2.5 MG/ML Extended Release Suspension	SY	ae304b29-0b40-40ec-ad0d-76b742d4a9b9	14
1720586	amphetamine 2.5 MG per 1 ML 24 HR Extended Release Suspension	SY	ae304b29-0b40-40ec-ad0d-76b742d4a9b9	14
1720586	amphetamine 2.5 MG/ML 24 HR Extended Release Suspension	SY	ae304b29-0b40-40ec-ad0d-76b742d4a9b9	14
2585461	Dyanavel 10 MG 24 HR Extended Release Oral Tablet	SY	ae304b29-0b40-40ec-ad0d-76b742d4a9b9	14
2585465	Dyanavel 15 MG 24 HR Extended Release Oral Tablet	SY	ae304b29-0b40-40ec-ad0d-76b742d4a9b9	14
2585471	Dyanavel 20 MG 24 HR Extended Release Oral Tablet	SY	ae304b29-0b40-40ec-ad0d-76b742d4a9b9	14
2585476	Dyanavel 5 MG 24 HR Extended Release Oral Tablet	SY	ae304b29-0b40-40ec-ad0d-76b742d4a9b9	14
1720592	Dyanavel XR 2.5 MG per 1 ML 24 HR Extended Release Suspension	SY	ae304b29-0b40-40ec-ad0d-76b742d4a9b9	14

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
24478-109-01	24478010901	30 TABLET, EXTENDED RELEASE in 1 BOTTLE (24478-109-01)	2022-08-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Dyanavel XR	NextWave Pharmaceuticals, Inc \| Tris Pharma Inc	2026-02-24	HUMAN PRESCRIPTION DRUG LABEL	14