Amphetamine Extended-Release

Product NDC
62542-015
11-digit product format
625420015
Labeler code
62542
Product ID
62542-015_3f9283a3-e922-36ca-e063-6394a90a409d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amphetamine Extended-Release
Dosage form
TABLET, ORALLY DISINTEGRATING
Route
ORAL
Labeler
Neos Therapeutics, LP
Application
NDA204326
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2025-09-01
Substance
AMPHETAMINE
Active strength
9.4 mg/1
Pharmacologic classes
Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]
DEA schedule
CII
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Amphetamine Extended-Release
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AMPHETAMINE9.4 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiCK833KGX7E
Rxcui1739803, 1739813, 1739819, 1739825, 1739831, 1739837

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
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
a90f088a-9578-47a2-8f6e-0a9d32aafec6Product name120181030
f6c90bdc-1674-455a-aadd-1b1b59e5edebProduct name220181030
57953747-955c-4dd8-9164-49d8ea877eaeProduct name120171113
fcc7ea58-a369-4e91-b092-5cde9ac2669fProduct name120160224
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508
f1ec5c2f-d01e-a277-5826-c7eba86ed99bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62542-015-30Amphetamine Extended-Release30 in 1 CARTONTABLET, ORALLY DISINTEGRATING305
62542-015-30Amphetamine Extended-Release6 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING65

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62542-015-30EA - Each62542-0152c33c2fe-1945-4cc9-8937-d7bcfa05c55012025-09-12

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1739803amphetamine 12.5 MG 24HR Extended Release Distintegrating Oral TabletPSN48d0f55c-f847-4d26-b2ed-94b5a27702285
1739813amphetamine 15.7 MG 24HR Extended Release Distintegrating Oral TabletPSN48d0f55c-f847-4d26-b2ed-94b5a27702285
1739819amphetamine 18.8 MG 24HR Extended Release Distintegrating Oral TabletPSN48d0f55c-f847-4d26-b2ed-94b5a27702285
1739825amphetamine 3.1 MG 24HR Extended Release Distintegrating Oral TabletPSN48d0f55c-f847-4d26-b2ed-94b5a27702285
1739831amphetamine 6.3 MG 24HR Extended Release Distintegrating Oral TabletPSN48d0f55c-f847-4d26-b2ed-94b5a27702285
1739837amphetamine 9.4 MG 24HR Extended Release Distintegrating Oral TabletPSN48d0f55c-f847-4d26-b2ed-94b5a27702285
173980324 HR amphetamine 12.5 MG Extended Release Oral TabletSCD48d0f55c-f847-4d26-b2ed-94b5a27702285
173981324 HR amphetamine 15.7 MG Extended Release Oral TabletSCD48d0f55c-f847-4d26-b2ed-94b5a27702285
173981924 HR amphetamine 18.8 MG Extended Release Oral TabletSCD48d0f55c-f847-4d26-b2ed-94b5a27702285
173982524 HR amphetamine 3.1 MG Extended Release Oral TabletSCD48d0f55c-f847-4d26-b2ed-94b5a27702285
173983124 HR amphetamine 6.3 MG Extended Release Oral TabletSCD48d0f55c-f847-4d26-b2ed-94b5a27702285
173983724 HR amphetamine 9.4 MG Extended Release Oral TabletSCD48d0f55c-f847-4d26-b2ed-94b5a27702285
1739803amphetamine 12.5 MG 24 HR Extended Release Distintegrating Oral TabletSY48d0f55c-f847-4d26-b2ed-94b5a27702285
1739813amphetamine 15.7 MG 24 HR Extended Release Distintegrating Oral TabletSY48d0f55c-f847-4d26-b2ed-94b5a27702285
1739819amphetamine 18.8 MG 24 HR Extended Release Distintegrating Oral TabletSY48d0f55c-f847-4d26-b2ed-94b5a27702285
1739825amphetamine 3.1 MG 24 HR Extended Release Distintegrating Oral TabletSY48d0f55c-f847-4d26-b2ed-94b5a27702285
1739831amphetamine 6.3 MG 24 HR Extended Release Distintegrating Oral TabletSY48d0f55c-f847-4d26-b2ed-94b5a27702285
1739837amphetamine 9.4 MG 24 HR Extended Release Distintegrating Oral TabletSY48d0f55c-f847-4d26-b2ed-94b5a27702285

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
62542-015-306254200153030 BLISTER PACK in 1 CARTON (62542-015-30) / 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK30 blister pack2025-09-01NoNoHistorical