FDA.reportPublic FDA data

DYANAVEL XR

Product NDC
24478-109
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

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AMPHETAMINE15 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiCK833KGX7E
Rxcui1720586, 1720592, 2585460, 2585461, 2585462, 2585465, 2585468, 2585471, 2585473, 2585476

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0f66b30d-6b15-4b2d-91a5-1531b9bb6d21Product name720250625
917bdf48-c3f5-4a58-ac8e-d2d94a9c1e2bProduct name220250616
8b92ab59-8b26-4c89-a2d6-8d5140526ec6Product name320231213
4496d022-9224-4ee0-943a-50fbe6cd7123Product name220220901
2a7aa275-a4ca-44eb-971f-47427a374085Product name920220615
93730fbf-8b45-4623-b27d-cf03825d04b3Product name520220314
a90f088a-9578-47a2-8f6e-0a9d32aafec6Product name120181030
f6c90bdc-1674-455a-aadd-1b1b59e5edebProduct name220181030
57953747-955c-4dd8-9164-49d8ea877eaeProduct name120171113
fcc7ea58-a369-4e91-b092-5cde9ac2669fProduct name120160224
f1ec5c2f-d01e-a277-5826-c7eba86ed99bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
24478-109-01DYANAVEL XR30 in 1 BOTTLETABLET, EXTENDED RELEASE3014

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
24478-109-01EA - Each24478-10961c048bf-81eb-4517-9b73-cab6f017706f12022-08-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
24478-109DYANAVEL XR (AMPHETAMINE) SUSPENSION, EXTENDED RELEASE DYANAVEL XR (AMPHETAMINE) TABLET, EXTENDED RELEASE [NEXTWAVE PHARMACEUTICALS, INC]4Current NDC, Legacy NDC, 1 package rows20231027_ae304b29-0b40-40ec-ad0d-76b742d4a9b9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2585460amphetamine 10 MG 24HR Extended Release Oral TabletPSNae304b29-0b40-40ec-ad0d-76b742d4a9b914
2585462amphetamine 15 MG 24HR Extended Release Oral TabletPSNae304b29-0b40-40ec-ad0d-76b742d4a9b914
1720586amphetamine 2.5 MG in 1 mL 24HR Extended Release SuspensionPSNae304b29-0b40-40ec-ad0d-76b742d4a9b914
2585468amphetamine 20 MG 24HR Extended Release Oral TabletPSNae304b29-0b40-40ec-ad0d-76b742d4a9b914
2585473amphetamine 5 MG 24HR Extended Release Oral TabletPSNae304b29-0b40-40ec-ad0d-76b742d4a9b914
2585461Dyanavel XR 10 MG 24HR Extended Release Oral TabletPSNae304b29-0b40-40ec-ad0d-76b742d4a9b914
2585465Dyanavel XR 15 MG 24HR Extended Release Oral TabletPSNae304b29-0b40-40ec-ad0d-76b742d4a9b914
1720592Dyanavel XR 2.5 MG in 1 mL 24HR Extended Release Oral SuspensionPSNae304b29-0b40-40ec-ad0d-76b742d4a9b914
2585471Dyanavel XR 20 MG 24HR Extended Release Oral TabletPSNae304b29-0b40-40ec-ad0d-76b742d4a9b914
2585476Dyanavel XR 5 MG 24HR Extended Release Oral TabletPSNae304b29-0b40-40ec-ad0d-76b742d4a9b914
258546124 HR amphetamine 10 MG Extended Release Oral Tablet [Dyanavel]SBDae304b29-0b40-40ec-ad0d-76b742d4a9b914
258546524 HR amphetamine 15 MG Extended Release Oral Tablet [Dyanavel]SBDae304b29-0b40-40ec-ad0d-76b742d4a9b914
172059224 HR amphetamine 2.5 MG/ML Extended Release Suspension [Dyanavel]SBDae304b29-0b40-40ec-ad0d-76b742d4a9b914
258547124 HR amphetamine 20 MG Extended Release Oral Tablet [Dyanavel]SBDae304b29-0b40-40ec-ad0d-76b742d4a9b914
258547624 HR amphetamine 5 MG Extended Release Oral Tablet [Dyanavel]SBDae304b29-0b40-40ec-ad0d-76b742d4a9b914
258546024 HR amphetamine 10 MG Extended Release Oral TabletSCDae304b29-0b40-40ec-ad0d-76b742d4a9b914
258546224 HR amphetamine 15 MG Extended Release Oral TabletSCDae304b29-0b40-40ec-ad0d-76b742d4a9b914
172058624 HR amphetamine 2.5 MG/ML Extended Release SuspensionSCDae304b29-0b40-40ec-ad0d-76b742d4a9b914
258546824 HR amphetamine 20 MG Extended Release Oral TabletSCDae304b29-0b40-40ec-ad0d-76b742d4a9b914
258547324 HR amphetamine 5 MG Extended Release Oral TabletSCDae304b29-0b40-40ec-ad0d-76b742d4a9b914
172059224 HR Dyanavel 2.5 MG/ML Extended Release SuspensionSYae304b29-0b40-40ec-ad0d-76b742d4a9b914
1720586amphetamine 2.5 MG per 1 ML 24 HR Extended Release SuspensionSYae304b29-0b40-40ec-ad0d-76b742d4a9b914
1720586amphetamine 2.5 MG/ML 24 HR Extended Release SuspensionSYae304b29-0b40-40ec-ad0d-76b742d4a9b914
2585461Dyanavel 10 MG 24 HR Extended Release Oral TabletSYae304b29-0b40-40ec-ad0d-76b742d4a9b914
2585465Dyanavel 15 MG 24 HR Extended Release Oral TabletSYae304b29-0b40-40ec-ad0d-76b742d4a9b914
2585471Dyanavel 20 MG 24 HR Extended Release Oral TabletSYae304b29-0b40-40ec-ad0d-76b742d4a9b914
2585476Dyanavel 5 MG 24 HR Extended Release Oral TabletSYae304b29-0b40-40ec-ad0d-76b742d4a9b914
1720592Dyanavel XR 2.5 MG per 1 ML 24 HR Extended Release SuspensionSYae304b29-0b40-40ec-ad0d-76b742d4a9b914

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
24478-109-012447801090130 TABLET, EXTENDED RELEASE in 1 BOTTLE (24478-109-01) 2022-08-010000-00-00NoNoCurrent