Amphetamine Sulfate

Product NDC
52536-057
11-digit product format
525360057
Labeler code
52536
Product ID
52536-057_87867bbf-4f82-42a0-9586-a9f530be1d2a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amphetamine Sulfate
Dosage form
TABLET
Route
ORAL
Labeler
Wilshire Pharmaceuticals, Inc.
Application
ANDA200166
Marketing category
ANDA
Marketing start
2018-03-29
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Amphetamine Sulfate
Listing expiration
2027-12-31

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
52536-057-03Amphetamine Sulfate30 in 1 BOTTLETABLET306
52536-057-10Amphetamine Sulfate100 in 1 BOTTLETABLET1006

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
52536-057-03EA - Each52536-0572b373779-75c4-42dd-b4ce-a1bb6b73699912021-05-05
52536-057-10EA - Each52536-057d9efaff6-6a6c-46a2-b411-3fec1dd40a5d12018-11-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52536-057AMPHETAMINE SULFATE TABLET [WILSHIRE PHARMACEUTICALS]4Current NDC, Legacy NDC, 2 package rows20231118_91add2e3-8359-47dc-b79f-197d36b02819.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
884655amphetamine sulfate 5 MG Oral TabletPSN674940ec-1714-4e41-b471-2a8c8a6c5ade104
884655amphetamine sulfate 5 MG Oral TabletSCD674940ec-1714-4e41-b471-2a8c8a6c5ade104
1600695amphetamine sulfate 10 MG Oral TabletPSN91add2e3-8359-47dc-b79f-197d36b028196
884655amphetamine sulfate 5 MG Oral TabletPSN91add2e3-8359-47dc-b79f-197d36b028196
1600695amphetamine sulfate 10 MG Oral TabletSCD91add2e3-8359-47dc-b79f-197d36b028196
884655amphetamine sulfate 5 MG Oral TabletSCD91add2e3-8359-47dc-b79f-197d36b028196
884655amphetamine sulfate 5 MG Oral TabletPSN920f99f4-ab78-4eed-9d80-08a2ebd0b7693
884655amphetamine sulfate 5 MG Oral TabletSCD920f99f4-ab78-4eed-9d80-08a2ebd0b7693

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
52536-057-035253600570330 TABLET in 1 BOTTLE (52536-057-03) 30 tablet2021-01-070000-00-00NoNoCurrent
52536-057-1052536005710100 TABLET in 1 BOTTLE (52536-057-10) 100 tablet2018-03-290000-00-00NoNoCurrent