FDA.reportPublic FDA data

Amphetamine

Product NDC
0480-3315
11-digit product format
004803315
Labeler code
0480
Product ID
0480-3315_4373ba4a-1fee-46df-bba9-b60e42cfd15a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amphetamine
Dosage form
TABLET, ORALLY DISINTEGRATING
Route
ORAL
Labeler
Teva Pharmaceuticals, Inc.
Application
ANDA209253
Marketing category
ANDA
Marketing start
2025-12-08
Substance
AMPHETAMINE
Active strength
3.1 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
Amphetamine
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AMPHETAMINE3.1 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
57953747-955c-4dd8-9164-49d8ea877eaeProduct name120171113
fcc7ea58-a369-4e91-b092-5cde9ac2669fProduct name120160224

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0480-3315-65Amphetamine6 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING62
0480-3315-65Amphetamine30 in 1 CARTONTABLET, ORALLY DISINTEGRATING302

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0480-3315-65EA - Each0480-3315257e75b5-f3b5-4da0-80c0-1ed91b21f2ae12026-01-08

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1739803amphetamine 12.5 MG 24HR Extended Release Distintegrating Oral TabletPSN243e88e7-6621-47e9-8d5c-3f79bcb088bb2
1739813amphetamine 15.7 MG 24HR Extended Release Distintegrating Oral TabletPSN243e88e7-6621-47e9-8d5c-3f79bcb088bb2
1739819amphetamine 18.8 MG 24HR Extended Release Distintegrating Oral TabletPSN243e88e7-6621-47e9-8d5c-3f79bcb088bb2
1739825amphetamine 3.1 MG 24HR Extended Release Distintegrating Oral TabletPSN243e88e7-6621-47e9-8d5c-3f79bcb088bb2
1739831amphetamine 6.3 MG 24HR Extended Release Distintegrating Oral TabletPSN243e88e7-6621-47e9-8d5c-3f79bcb088bb2
1739837amphetamine 9.4 MG 24HR Extended Release Distintegrating Oral TabletPSN243e88e7-6621-47e9-8d5c-3f79bcb088bb2
173980324 HR amphetamine 12.5 MG Extended Release Oral TabletSCD243e88e7-6621-47e9-8d5c-3f79bcb088bb2
173981324 HR amphetamine 15.7 MG Extended Release Oral TabletSCD243e88e7-6621-47e9-8d5c-3f79bcb088bb2
173981924 HR amphetamine 18.8 MG Extended Release Oral TabletSCD243e88e7-6621-47e9-8d5c-3f79bcb088bb2
173982524 HR amphetamine 3.1 MG Extended Release Oral TabletSCD243e88e7-6621-47e9-8d5c-3f79bcb088bb2
173983124 HR amphetamine 6.3 MG Extended Release Oral TabletSCD243e88e7-6621-47e9-8d5c-3f79bcb088bb2
173983724 HR amphetamine 9.4 MG Extended Release Oral TabletSCD243e88e7-6621-47e9-8d5c-3f79bcb088bb2
1739803amphetamine 12.5 MG 24 HR Extended Release Distintegrating Oral TabletSY243e88e7-6621-47e9-8d5c-3f79bcb088bb2
1739813amphetamine 15.7 MG 24 HR Extended Release Distintegrating Oral TabletSY243e88e7-6621-47e9-8d5c-3f79bcb088bb2
1739819amphetamine 18.8 MG 24 HR Extended Release Distintegrating Oral TabletSY243e88e7-6621-47e9-8d5c-3f79bcb088bb2
1739825amphetamine 3.1 MG 24 HR Extended Release Distintegrating Oral TabletSY243e88e7-6621-47e9-8d5c-3f79bcb088bb2
1739831amphetamine 6.3 MG 24 HR Extended Release Distintegrating Oral TabletSY243e88e7-6621-47e9-8d5c-3f79bcb088bb2
1739837amphetamine 9.4 MG 24 HR Extended Release Distintegrating Oral TabletSY243e88e7-6621-47e9-8d5c-3f79bcb088bb2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0480-3315-650048033156530 BLISTER PACK in 1 CARTON (0480-3315-65) / 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK30 blister pack2025-12-08NoNoHistorical