dextroamphetamine sulfate

Product NDC
58177-312
11-digit product format
581770312
Labeler code
58177
Product ID
58177-312_1969d6f2-3f37-4317-a73b-09158f83e59c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
dextroamphetamine sulfate
Dosage form
TABLET
Route
ORAL
Labeler
Ethex Corporation
Application
ANDA040367
Marketing category
ANDA
Marketing start
2009-11-01
Marketing end
0000-00-00
Substance
DEXTROAMPHETAMINE SULFATE
Active strength
10 mg/1
Pharmacologic classes
Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE]
DEA schedule
CII
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0f66b30d-6b15-4b2d-91a5-1531b9bb6d21Product name720250625
917bdf48-c3f5-4a58-ac8e-d2d94a9c1e2bProduct name220250616
b4c312b9-fad5-247e-cef9-87a74220463dProduct name520230426
8170729e-5ba4-46f9-830f-5f0fae5942ceProduct name120230103
2a7aa275-a4ca-44eb-971f-47427a374085Product name920220615
aa1b3c66-c4f6-78f2-abd3-31cc9d555e27Product name520190913
b4c312b9-fad5-247e-cef9-87a74220463dProduct name420171211
ffdf7f68-0f44-4dd6-a026-336dcb345fc4Product name120151109

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58177-312-04dextroamphetamine sulfate100 in 1 BOTTLETABLET1001
58177-312-04Dextroamphetamine Sulfate100 in 1 BOTTLETABLET1001
58177-312-09Dextroamphetamine Sulfate1000 in 1 BOTTLETABLET10001
58177-312-09dextroamphetamine sulfate1000 in 1 BOTTLETABLET10001

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Dextroamphetamine SulfateACTIVE INGREDIENTJJ768O327NDEXTROAMPHETAMINE SULFATE (DEXTROAMPHETAMINE SULFATE) TABLET [ETHEX CORPORATION]1
dextroamphetamine sulfateACTIVE INGREDIENTJJ768O327NDEXTROAMPHETAMINE SULFATE TABLET [ETHEX CORPORATION]1
dextroamphetamineACTIVE MOIETYTZ47U051FIDEXTROAMPHETAMINE SULFATE TABLET [ETHEX CORPORATION]1
dextroamphetamineACTIVE MOIETYTZ47U051FIDEXTROAMPHETAMINE SULFATE (DEXTROAMPHETAMINE SULFATE) TABLET [ETHEX CORPORATION]1
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933DEXTROAMPHETAMINE SULFATE TABLET [ETHEX CORPORATION]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UDEXTROAMPHETAMINE SULFATE TABLET [ETHEX CORPORATION]1
D&C Yellow No. 10INACTIVE INGREDIENTDEXTROAMPHETAMINE SULFATE (DEXTROAMPHETAMINE SULFATE) TABLET [ETHEX CORPORATION]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GDEXTROAMPHETAMINE SULFATE TABLET [ETHEX CORPORATION]1
FD&C Blue No. 2INACTIVE INGREDIENTDEXTROAMPHETAMINE SULFATE (DEXTROAMPHETAMINE SULFATE) TABLET [ETHEX CORPORATION]1
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKDEXTROAMPHETAMINE SULFATE TABLET [ETHEX CORPORATION]1
FD&C Red No. 40INACTIVE INGREDIENTDEXTROAMPHETAMINE SULFATE (DEXTROAMPHETAMINE SULFATE) TABLET [ETHEX CORPORATION]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOADEXTROAMPHETAMINE SULFATE TABLET [ETHEX CORPORATION]1
hydrated aluminaINACTIVE INGREDIENTDEXTROAMPHETAMINE SULFATE (DEXTROAMPHETAMINE SULFATE) TABLET [ETHEX CORPORATION]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XDEXTROAMPHETAMINE SULFATE TABLET [ETHEX CORPORATION]1
lactose monohydrateINACTIVE INGREDIENTEWQ57Q8I5XDEXTROAMPHETAMINE SULFATE (DEXTROAMPHETAMINE SULFATE) TABLET [ETHEX CORPORATION]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30DEXTROAMPHETAMINE SULFATE TABLET [ETHEX CORPORATION]1
magnesium stearateINACTIVE INGREDIENT70097M6I30DEXTROAMPHETAMINE SULFATE (DEXTROAMPHETAMINE SULFATE) TABLET [ETHEX CORPORATION]1
maltodextrinINACTIVE INGREDIENTDEXTROAMPHETAMINE SULFATE (DEXTROAMPHETAMINE SULFATE) TABLET [ETHEX CORPORATION]1
MALTODEXTRININACTIVE INGREDIENT7CVR7L4A2DDEXTROAMPHETAMINE SULFATE TABLET [ETHEX CORPORATION]1
mannitolINACTIVE INGREDIENT3OWL53L36ADEXTROAMPHETAMINE SULFATE (DEXTROAMPHETAMINE SULFATE) TABLET [ETHEX CORPORATION]1
microcrystalline celluloseINACTIVE INGREDIENTDEXTROAMPHETAMINE SULFATE (DEXTROAMPHETAMINE SULFATE) TABLET [ETHEX CORPORATION]1
POVIDONEINACTIVE INGREDIENTFZ989GH94EDEXTROAMPHETAMINE SULFATE TABLET [ETHEX CORPORATION]1
povidoneINACTIVE INGREDIENTFZ989GH94EDEXTROAMPHETAMINE SULFATE (DEXTROAMPHETAMINE SULFATE) TABLET [ETHEX CORPORATION]1
sodium starch glycolate sugar compressibleINACTIVE INGREDIENTDEXTROAMPHETAMINE SULFATE (DEXTROAMPHETAMINE SULFATE) TABLET [ETHEX CORPORATION]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2DEXTROAMPHETAMINE SULFATE TABLET [ETHEX CORPORATION]1
starchINACTIVE INGREDIENTDEXTROAMPHETAMINE SULFATE (DEXTROAMPHETAMINE SULFATE) TABLET [ETHEX CORPORATION]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJDEXTROAMPHETAMINE SULFATE TABLET [ETHEX CORPORATION]1
stearic acidINACTIVE INGREDIENT4ELV7Z65APDEXTROAMPHETAMINE SULFATE (DEXTROAMPHETAMINE SULFATE) TABLET [ETHEX CORPORATION]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APDEXTROAMPHETAMINE SULFATE TABLET [ETHEX CORPORATION]1
SUCROSEINACTIVE INGREDIENTC151H8M554DEXTROAMPHETAMINE SULFATE TABLET [ETHEX CORPORATION]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58177-312DEXTROAMPHETAMINE SULFATE (DEXTROAMPHETAMINE SULFATE) TABLET [ETHEX CORPORATION]1Legacy NDC20080404_Bed3c03f4-2829-423f-a595-dc09c9cc0e40.zip
58177-312DEXTROAMPHETAMINE SULFATE TABLET [ETHEX CORPORATION]1Legacy NDC, 2 package rows20091204_b2ad8d2b-ed94-43cd-95ea-85e91d997f26.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
884385dextroamphetamine sulfate 10 MG Oral TabletPSNb2ad8d2b-ed94-43cd-95ea-85e91d997f261
884385dextroamphetamine sulfate 10 MG Oral TabletPSNbed3c03f4-2829-423f-a595-dc09c9cc0e41
884386dextroamphetamine sulfate 5 MG Oral TabletPSNb2ad8d2b-ed94-43cd-95ea-85e91d997f261
884386dextroamphetamine sulfate 5 MG Oral TabletPSNbed3c03f4-2829-423f-a595-dc09c9cc0e41
884385dextroamphetamine sulfate 10 MG Oral TabletSCDb2ad8d2b-ed94-43cd-95ea-85e91d997f261
884385dextroamphetamine sulfate 10 MG Oral TabletSCDbed3c03f4-2829-423f-a595-dc09c9cc0e41
884386dextroamphetamine sulfate 5 MG Oral TabletSCDb2ad8d2b-ed94-43cd-95ea-85e91d997f261
884386dextroamphetamine sulfate 5 MG Oral TabletSCDbed3c03f4-2829-423f-a595-dc09c9cc0e41

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
58177-312-0458177031204100 in 1 BOTTLEHistorical
58177-312-09581770312091000 in 1 BOTTLEHistorical