Amphetamine Sulfate

Product NDC
0406-1219
11-digit product format
004061219
Labeler code
0406
Product ID
0406-1219_8fdfec51-e7c0-429b-a3f4-8f5ae2679147
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amphetamine Sulfate
Dosage form
TABLET
Route
ORAL
Labeler
SpecGx LLC
Application
ANDA213583
Marketing category
ANDA
Marketing start
2021-02-28
Substance
AMPHETAMINE SULFATE
Active strength
5 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 Sulfate
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AMPHETAMINE SULFATE5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii6DPV8NK46S
Rxcui884655, 1600695

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
0406-1219-01Amphetamine Sulfate100 in 1 BOTTLETABLET10010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0406-1219-01EA - Each0406-12198bb29444-dfaa-4609-a8a7-c7b3e19c180312021-08-05

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1600695amphetamine sulfate 10 MG Oral TabletPSN00242264-40d8-4267-a91a-727a1f08861610
884655amphetamine sulfate 5 MG Oral TabletPSN00242264-40d8-4267-a91a-727a1f08861610
1600695amphetamine sulfate 10 MG Oral TabletSCD00242264-40d8-4267-a91a-727a1f08861610
884655amphetamine sulfate 5 MG Oral TabletSCD00242264-40d8-4267-a91a-727a1f08861610

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0406-1219-0100406121901100 TABLET in 1 BOTTLE (0406-1219-01) 100 tablet2021-02-280000-00-00NoNoCurrent