FDA.reportPublic FDA data

Dextroamphetamine Sulfate

Product NDC
0406-8960
11-digit product format
004068960
Labeler code
0406
Product ID
0406-8960_78bafc02-003f-497f-b8c0-2bb063b3fa35
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
dextroamphetamine sulfate
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
SpecGx LLC
Application
ANDA076353
Marketing category
ANDA
Marketing start
2003-05-06
Substance
DEXTROAMPHETAMINE 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
Dextroamphetamine Sulfate
Brand name suffix
Extended-Release
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DEXTROAMPHETAMINE SULFATE5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiJJ768O327N
Rxcui884520, 884532, 884535

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0406-8960-01Dextroamphetamine SulfateExtended-Release100 in 1 BOTTLECAPSULE, EXTENDED RELEASE10023

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0406-8960-01EA - Each0406-8960c7c3a7d0-6821-46d0-bc89-dea0ba4bdad912012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DEXTROAMPHETAMINE SULFATEACTIVE INGREDIENTJJ768O327NDEXTROAMPHETAMINE SULFATE EXTENDED-RELEASE (DEXTROAMPHETAMINE SULFATE) CAPSULE, EXTENDED RELEASE [MALLINCKRODT, INC.]11
DEXTROAMPHETAMINEACTIVE MOIETYTZ47U051FIDEXTROAMPHETAMINE SULFATE EXTENDED-RELEASE (DEXTROAMPHETAMINE SULFATE) CAPSULE, EXTENDED RELEASE [MALLINCKRODT, INC.]11
ALCOHOLINACTIVE INGREDIENT3K9958V90MDEXTROAMPHETAMINE SULFATE EXTENDED-RELEASE (DEXTROAMPHETAMINE SULFATE) CAPSULE, EXTENDED RELEASE [MALLINCKRODT, INC.]11
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933DEXTROAMPHETAMINE SULFATE EXTENDED-RELEASE (DEXTROAMPHETAMINE SULFATE) CAPSULE, EXTENDED RELEASE [MALLINCKRODT, INC.]11
AMMONIAINACTIVE INGREDIENT5138Q19F1XDEXTROAMPHETAMINE SULFATE EXTENDED-RELEASE (DEXTROAMPHETAMINE SULFATE) CAPSULE, EXTENDED RELEASE [MALLINCKRODT, INC.]11
BUTYL ALCOHOLINACTIVE INGREDIENT8PJ61P6TS3DEXTROAMPHETAMINE SULFATE EXTENDED-RELEASE (DEXTROAMPHETAMINE SULFATE) CAPSULE, EXTENDED RELEASE [MALLINCKRODT, INC.]11
CORN STARCH 3-E-DODECENYL SUCCINIC ANHYDRIDE MODIFIEDINACTIVE INGREDIENTQG4MW19XYXDEXTROAMPHETAMINE SULFATE EXTENDED-RELEASE (DEXTROAMPHETAMINE SULFATE) CAPSULE, EXTENDED RELEASE [MALLINCKRODT, INC.]11
ETHYLCELLULOSE (20 MPA.S)INACTIVE INGREDIENTBJG0S321QYDEXTROAMPHETAMINE SULFATE EXTENDED-RELEASE (DEXTROAMPHETAMINE SULFATE) CAPSULE, EXTENDED RELEASE [MALLINCKRODT, INC.]11
ETHYLCELLULOSESINACTIVE INGREDIENT7Z8S9VYZ4BDEXTROAMPHETAMINE SULFATE EXTENDED-RELEASE (DEXTROAMPHETAMINE SULFATE) CAPSULE, EXTENDED RELEASE [MALLINCKRODT, INC.]11
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDDEXTROAMPHETAMINE SULFATE EXTENDED-RELEASE (DEXTROAMPHETAMINE SULFATE) CAPSULE, EXTENDED RELEASE [MALLINCKRODT, INC.]11
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKDEXTROAMPHETAMINE SULFATE EXTENDED-RELEASE (DEXTROAMPHETAMINE SULFATE) CAPSULE, EXTENDED RELEASE [MALLINCKRODT, INC.]11
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOADEXTROAMPHETAMINE SULFATE EXTENDED-RELEASE (DEXTROAMPHETAMINE SULFATE) CAPSULE, EXTENDED RELEASE [MALLINCKRODT, INC.]11
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357DEXTROAMPHETAMINE SULFATE EXTENDED-RELEASE (DEXTROAMPHETAMINE SULFATE) CAPSULE, EXTENDED RELEASE [MALLINCKRODT, INC.]11
GELATININACTIVE INGREDIENT2G86QN327LDEXTROAMPHETAMINE SULFATE EXTENDED-RELEASE (DEXTROAMPHETAMINE SULFATE) CAPSULE, EXTENDED RELEASE [MALLINCKRODT, INC.]11
HYPROMELLOSE 2208 (100000 MPA.S)INACTIVE INGREDIENTVM7F0B23ZIDEXTROAMPHETAMINE SULFATE EXTENDED-RELEASE (DEXTROAMPHETAMINE SULFATE) CAPSULE, EXTENDED RELEASE [MALLINCKRODT, INC.]11
ISOPROPYL ALCOHOLINACTIVE INGREDIENTND2M416302DEXTROAMPHETAMINE SULFATE EXTENDED-RELEASE (DEXTROAMPHETAMINE SULFATE) CAPSULE, EXTENDED RELEASE [MALLINCKRODT, INC.]11
MEDIUM-CHAIN TRIGLYCERIDESINACTIVE INGREDIENTC9H2L21V7UDEXTROAMPHETAMINE SULFATE EXTENDED-RELEASE (DEXTROAMPHETAMINE SULFATE) CAPSULE, EXTENDED RELEASE [MALLINCKRODT, INC.]11
OLEIC ACIDINACTIVE INGREDIENT2UMI9U37CPDEXTROAMPHETAMINE SULFATE EXTENDED-RELEASE (DEXTROAMPHETAMINE SULFATE) CAPSULE, EXTENDED RELEASE [MALLINCKRODT, INC.]11
POLYETHYLENE GLYCOL 1000INACTIVE INGREDIENTU076Q6Q621DEXTROAMPHETAMINE SULFATE EXTENDED-RELEASE (DEXTROAMPHETAMINE SULFATE) CAPSULE, EXTENDED RELEASE [MALLINCKRODT, INC.]11
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ADEXTROAMPHETAMINE SULFATE EXTENDED-RELEASE (DEXTROAMPHETAMINE SULFATE) CAPSULE, EXTENDED RELEASE [MALLINCKRODT, INC.]11
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3DEXTROAMPHETAMINE SULFATE EXTENDED-RELEASE (DEXTROAMPHETAMINE SULFATE) CAPSULE, EXTENDED RELEASE [MALLINCKRODT, INC.]11
SHELLACINACTIVE INGREDIENT46N107B71ODEXTROAMPHETAMINE SULFATE EXTENDED-RELEASE (DEXTROAMPHETAMINE SULFATE) CAPSULE, EXTENDED RELEASE [MALLINCKRODT, INC.]11
SUCROSEINACTIVE INGREDIENTC151H8M554DEXTROAMPHETAMINE SULFATE EXTENDED-RELEASE (DEXTROAMPHETAMINE SULFATE) CAPSULE, EXTENDED RELEASE [MALLINCKRODT, INC.]11
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPDEXTROAMPHETAMINE SULFATE EXTENDED-RELEASE (DEXTROAMPHETAMINE SULFATE) CAPSULE, EXTENDED RELEASE [MALLINCKRODT, INC.]11
WATERINACTIVE INGREDIENT059QF0KO0RDEXTROAMPHETAMINE SULFATE EXTENDED-RELEASE (DEXTROAMPHETAMINE SULFATE) CAPSULE, EXTENDED RELEASE [MALLINCKRODT, INC.]11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0406-8960DEXTROAMPHETAMINE SULFATE EXTENDED-RELEASE (DEXTROAMPHETAMINE SULFATE) CAPSULE, EXTENDED RELEASE [SPECGX LLC]22Current NDC, Legacy NDC, 1 package rows20240719_69c40af8-3710-46bf-bd3d-137fe5eea23e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
884520dextroamphetamine sulfate 10 MG Extended Release Oral CapsulePSN69c40af8-3710-46bf-bd3d-137fe5eea23e23
884532dextroamphetamine sulfate 15 MG Extended Release Oral CapsulePSN69c40af8-3710-46bf-bd3d-137fe5eea23e23
884535dextroamphetamine sulfate 5 MG Extended Release Oral CapsulePSN69c40af8-3710-46bf-bd3d-137fe5eea23e23
884520dextroamphetamine sulfate 10 MG Extended Release Oral CapsuleSCD69c40af8-3710-46bf-bd3d-137fe5eea23e23
884532dextroamphetamine sulfate 15 MG Extended Release Oral CapsuleSCD69c40af8-3710-46bf-bd3d-137fe5eea23e23
884535dextroamphetamine sulfate 5 MG Extended Release Oral CapsuleSCD69c40af8-3710-46bf-bd3d-137fe5eea23e23

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0406-8960-0100406896001100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0406-8960-01) 2003-05-060000-00-00NoNoCurrent