FDA.reportPublic FDA data

Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate

Product NDC
0228-3064
11-digit product format
002283064
Labeler code
0228
Product ID
0228-3064_75c254af-0db3-4c40-83ad-f308be628dde
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Actavis Pharma, Inc.
Application
ANDA077302
Marketing category
ANDA
Marketing start
2012-06-22
Substance
AMPHETAMINE ASPARTATE MONOHYDRATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE
Active strength
6.25; 6.25; 6.25; 6.25 mg/1; mg/1; mg/1; mg/1
Pharmacologic classes
Central Nervous System Stimulant [EPC], Central Nervous System Stimulant [EPC], Central Nervous System Stimulant [EPC], Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Central Nervous System Stimulation [PE], Central Nervous System Stimulation [PE], 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
Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AMPHETAMINE ASPARTATE MONOHYDRATE6.25 mg/1
AMPHETAMINE SULFATE6.25 mg/1
DEXTROAMPHETAMINE SACCHARATE6.25 mg/1
DEXTROAMPHETAMINE SULFATE6.25 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiO1ZPV620O4, JJ768O327N, G83415V073, 6DPV8NK46S
Rxcui861221, 861223, 861225, 861227, 861232, 861237

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
b4c312b9-fad5-247e-cef9-87a74220463dProduct name520230426
8170729e-5ba4-46f9-830f-5f0fae5942ceProduct name120230103
4496d022-9224-4ee0-943a-50fbe6cd7123Product name220220901
2a7aa275-a4ca-44eb-971f-47427a374085Product name920220615
93730fbf-8b45-4623-b27d-cf03825d04b3Product name520220314
aa1b3c66-c4f6-78f2-abd3-31cc9d555e27Product name520190913
b4c312b9-fad5-247e-cef9-87a74220463dProduct name420171211
57953747-955c-4dd8-9164-49d8ea877eaeProduct name120171113
fcc7ea58-a369-4e91-b092-5cde9ac2669fProduct name120160224
ffdf7f68-0f44-4dd6-a026-336dcb345fc4Product name120151109

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0228-3064-11Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate100 in 1 BOTTLECAPSULE, EXTENDED RELEASE10035

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0228-3064-11EA - Each0228-30648a2fd2fa-ff33-4a89-8c06-35dccb0fb38e12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AMPHETAMINE ASPARTATE MONOHYDRATEACTIVE INGREDIENTO1ZPV620O4DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE, AMPHETAMINE SULFATE CAPSULE, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]21
AMPHETAMINE SULFATEACTIVE INGREDIENT6DPV8NK46SDEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE, AMPHETAMINE SULFATE CAPSULE, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]21
DEXTROAMPHETAMINE SACCHARATEACTIVE INGREDIENTG83415V073DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE, AMPHETAMINE SULFATE CAPSULE, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]21
DEXTROAMPHETAMINE SULFATEACTIVE INGREDIENTJJ768O327NDEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE, AMPHETAMINE SULFATE CAPSULE, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]21
AMPHETAMINEACTIVE MOIETYCK833KGX7EDEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE, AMPHETAMINE SULFATE CAPSULE, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]21
DEXTROAMPHETAMINEACTIVE MOIETYTZ47U051FIDEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE, AMPHETAMINE SULFATE CAPSULE, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]21
AMMONIO METHACRYLATE COPOLYMER TYPE AINACTIVE INGREDIENT8GQS4E66YYDEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE, AMPHETAMINE SULFATE CAPSULE, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]21
AMMONIO METHACRYLATE COPOLYMER TYPE BINACTIVE INGREDIENT161H3B14U2DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE, AMPHETAMINE SULFATE CAPSULE, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]21
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GDEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE, AMPHETAMINE SULFATE CAPSULE, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]21
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDDEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE, AMPHETAMINE SULFATE CAPSULE, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]21
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKDEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE, AMPHETAMINE SULFATE CAPSULE, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]21
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOADEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE, AMPHETAMINE SULFATE CAPSULE, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]21
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE, AMPHETAMINE SULFATE CAPSULE, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]21
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTDEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE, AMPHETAMINE SULFATE CAPSULE, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]21
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE, AMPHETAMINE SULFATE CAPSULE, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]21
GELATININACTIVE INGREDIENT2G86QN327LDEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE, AMPHETAMINE SULFATE CAPSULE, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]21
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PDEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE, AMPHETAMINE SULFATE CAPSULE, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]21
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE, AMPHETAMINE SULFATE CAPSULE, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]21
SHELLACINACTIVE INGREDIENT46N107B71ODEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE, AMPHETAMINE SULFATE CAPSULE, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]21
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJDEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE, AMPHETAMINE SULFATE CAPSULE, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]21
SUCROSEINACTIVE INGREDIENTC151H8M554DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE, AMPHETAMINE SULFATE CAPSULE, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]21
TALCINACTIVE INGREDIENT7SEV7J4R1UDEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE, AMPHETAMINE SULFATE CAPSULE, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]21
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPDEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE, AMPHETAMINE SULFATE CAPSULE, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]21
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMDEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE, AMPHETAMINE SULFATE CAPSULE, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]21

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0228-3064DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE, AMPHETAMINE SULFATE CAPSULE, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]31Current NDC, Legacy NDC, 1 package rows20240210_c5c2d060-452c-4f76-ad93-2e41fd8f06c2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
861237dextroamphetamine saccharate 1.25 MG / amphetamine aspartate 1.25 MG / dextroamphetamine sulfate 1.25 MG / amphetamine sulfate 1.25 MG 24HR Extended Release Oral CapsulePSNc5c2d060-452c-4f76-ad93-2e41fd8f06c235
861221dextroamphetamine saccharate 2.5 MG / amphetamine aspartate 2.5 MG / dextroamphetamine sulfate 2.5 MG / amphetamine sulfate 2.5 MG 24HR Extended Release Oral CapsulePSNc5c2d060-452c-4f76-ad93-2e41fd8f06c235
861223dextroamphetamine saccharate 3.75 MG / amphetamine aspartate 3.75 MG / dextroamphetamine sulfate 3.75 MG / amphetamine sulfate 3.75 MG 24HR Extended Release Oral CapsulePSNc5c2d060-452c-4f76-ad93-2e41fd8f06c235
861225dextroamphetamine saccharate 5 MG / amphetamine aspartate 5 MG / dextroamphetamine sulfate 5 MG / amphetamine sulfate 5 MG 24HR Extended Release Oral CapsulePSNc5c2d060-452c-4f76-ad93-2e41fd8f06c235
861227dextroamphetamine saccharate 6.25 MG / amphetamine aspartate 6.25 MG / dextroamphetamine sulfate 6.25 MG / amphetamine sulfate 6.25 MG 24HR Extended Release Oral CapsulePSNc5c2d060-452c-4f76-ad93-2e41fd8f06c235
861232dextroamphetamine saccharate 7.5 MG / amphetamine aspartate 7.5 MG / dextroamphetamine sulfate 7.5 MG / amphetamine sulfate 7.5 MG 24HR Extended Release Oral CapsulePSNc5c2d060-452c-4f76-ad93-2e41fd8f06c235
86123724 HR amphetamine aspartate 1.25 MG / amphetamine sulfate 1.25 MG / dextroamphetamine saccharate 1.25 MG / dextroamphetamine sulfate 1.25 MG Extended Release Oral CapsuleSCDc5c2d060-452c-4f76-ad93-2e41fd8f06c235
86122124 HR amphetamine aspartate 2.5 MG / amphetamine sulfate 2.5 MG / dextroamphetamine saccharate 2.5 MG / dextroamphetamine sulfate 2.5 MG Extended Release Oral CapsuleSCDc5c2d060-452c-4f76-ad93-2e41fd8f06c235
86122324 HR amphetamine aspartate 3.75 MG / amphetamine sulfate 3.75 MG / dextroamphetamine saccharate 3.75 MG / dextroamphetamine sulfate 3.75 MG Extended Release Oral CapsuleSCDc5c2d060-452c-4f76-ad93-2e41fd8f06c235
86122524 HR amphetamine aspartate 5 MG / amphetamine sulfate 5 MG / dextroamphetamine saccharate 5 MG / dextroamphetamine sulfate 5 MG Extended Release Oral CapsuleSCDc5c2d060-452c-4f76-ad93-2e41fd8f06c235
86122724 HR amphetamine aspartate 6.25 MG / amphetamine sulfate 6.25 MG / dextroamphetamine saccharate 6.25 MG / dextroamphetamine sulfate 6.25 MG Extended Release Oral CapsuleSCDc5c2d060-452c-4f76-ad93-2e41fd8f06c235
86123224 HR amphetamine aspartate 7.5 MG / amphetamine sulfate 7.5 MG / dextroamphetamine saccharate 7.5 MG / dextroamphetamine sulfate 7.5 MG Extended Release Oral CapsuleSCDc5c2d060-452c-4f76-ad93-2e41fd8f06c235
861237amphetamine aspartate 1.25 MG / amphetamine sulfate 1.25 MG / dextroamphetamine saccharate 1.25 MG / dextroamphetamine sulfate 1.25 MG 24 HR Extended Release Oral CapsuleSYc5c2d060-452c-4f76-ad93-2e41fd8f06c235
861221amphetamine aspartate 2.5 MG / amphetamine sulfate 2.5 MG / dextroamphetamine saccharate 2.5 MG / dextroamphetamine sulfate 2.5 MG 24 HR Extended Release Oral CapsuleSYc5c2d060-452c-4f76-ad93-2e41fd8f06c235
861223amphetamine aspartate 3.75 MG / amphetamine sulfate 3.75 MG / dextroamphetamine saccharate 3.75 MG / dextroamphetamine sulfate 3.75 MG 24 HR Extended Release Oral CapsuleSYc5c2d060-452c-4f76-ad93-2e41fd8f06c235
861225amphetamine aspartate 5 MG / amphetamine sulfate 5 MG / dextroamphetamine saccharate 5 MG / dextroamphetamine sulfate 5 MG 24 HR Extended Release Oral CapsuleSYc5c2d060-452c-4f76-ad93-2e41fd8f06c235
861227amphetamine aspartate 6.25 MG / amphetamine sulfate 6.25 MG / dextroamphetamine saccharate 6.25 MG / dextroamphetamine sulfate 6.25 MG 24 HR Extended Release Oral CapsuleSYc5c2d060-452c-4f76-ad93-2e41fd8f06c235
861232amphetamine aspartate 7.5 MG / amphetamine sulfate 7.5 MG / dextroamphetamine saccharate 7.5 MG / dextroamphetamine sulfate 7.5 MG 24 HR Extended Release Oral CapsuleSYc5c2d060-452c-4f76-ad93-2e41fd8f06c235

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0228-3064-1100228306411100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0228-3064-11) 2012-06-220000-00-00NoNoCurrent