FDA.reportPublic FDA data

Dextroamphetamine Sulfate

Product NDC
0115-9928
11-digit product format
001159928
Labeler code
0115
Product ID
0115-9928_42b19d09-cffd-4772-bc84-76c2066d6f00
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dextroamphetamine Sulfate
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Amneal Pharmaceuticals of New York LLC
Application
NDA017078
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
1976-08-02
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
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 SULFATE10 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
0115-9928-10Dextroamphetamine SulfateExtended-Release90 in 1 BOTTLECAPSULE, EXTENDED RELEASE9012

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0115-9928-10EA - Each0115-99284e93a78d-d9e6-469f-be51-a4b92f52508712019-01-24

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0115-9928DEXTROAMPHETAMINE SULFATE EXTENDED-RELEASE (DEXTROAMPHETAMINE SULFATE) CAPSULE, EXTENDED RELEASE [AMNEAL PHARMACEUTICALS OF NEW YORK LLC]12Current NDC, Legacy NDC, 1 package rows20231231_2ec5c30f-4eb8-48a5-83c4-236450413464.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
884520dextroamphetamine sulfate 10 MG Extended Release Oral CapsulePSN2ec5c30f-4eb8-48a5-83c4-23645041346412
884532dextroamphetamine sulfate 15 MG Extended Release Oral CapsulePSN2ec5c30f-4eb8-48a5-83c4-23645041346412
884535dextroamphetamine sulfate 5 MG Extended Release Oral CapsulePSN2ec5c30f-4eb8-48a5-83c4-23645041346412
884520dextroamphetamine sulfate 10 MG Extended Release Oral CapsuleSCD2ec5c30f-4eb8-48a5-83c4-23645041346412
884532dextroamphetamine sulfate 15 MG Extended Release Oral CapsuleSCD2ec5c30f-4eb8-48a5-83c4-23645041346412
884535dextroamphetamine sulfate 5 MG Extended Release Oral CapsuleSCD2ec5c30f-4eb8-48a5-83c4-23645041346412

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0115-9928-100011599281090 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0115-9928-10) 1976-08-020000-00-00NoNoCurrent