AMPHETAMINE SULFATE

Product NDC
43547-458
11-digit product format
435470458
Labeler code
43547
Product ID
43547-458_b11d796e-584c-49a4-9f05-b499f5cd0f5e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
amphetamine sulfate
Dosage form
TABLET
Route
ORAL
Labeler
Solco Healthcare US, LLC
Application
ANDA211861
Marketing category
ANDA
Marketing start
2020-04-02
Substance
AMPHETAMINE SULFATE
Active strength
10 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 SULFATE10 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
43547-458-10AMPHETAMINE SULFATE100 in 1 BOTTLETABLET1008

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43547-458AMPHETAMINE SULFATE TABLET [SOLCO HEALTHCARE US, LLC]6Current NDC, Legacy NDC, 1 package rows20231013_89c5b52f-3c2a-41d5-8624-9ee51c512c72.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1600695amphetamine sulfate 10 MG Oral TabletPSN7f16dd18-bf30-41ef-8981-932da5df0951100
1600695amphetamine sulfate 10 MG Oral TabletSCD7f16dd18-bf30-41ef-8981-932da5df0951100
1600695amphetamine sulfate 10 MG Oral TabletPSN89c5b52f-3c2a-41d5-8624-9ee51c512c728
884655amphetamine sulfate 5 MG Oral TabletPSN89c5b52f-3c2a-41d5-8624-9ee51c512c728
1600695amphetamine sulfate 10 MG Oral TabletSCD89c5b52f-3c2a-41d5-8624-9ee51c512c728
884655amphetamine sulfate 5 MG Oral TabletSCD89c5b52f-3c2a-41d5-8624-9ee51c512c728
1600695amphetamine sulfate 10 MG Oral TabletPSN8f9341fc-4b95-4556-a51a-ea972fa6fccc3
884655amphetamine sulfate 5 MG Oral TabletPSN8f9341fc-4b95-4556-a51a-ea972fa6fccc3
1600695amphetamine sulfate 10 MG Oral TabletSCD8f9341fc-4b95-4556-a51a-ea972fa6fccc3
884655amphetamine sulfate 5 MG Oral TabletSCD8f9341fc-4b95-4556-a51a-ea972fa6fccc3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43547-458-1043547045810100 TABLET in 1 BOTTLE (43547-458-10) 100 tablet2020-04-020000-00-00NoNoCurrent