Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfate

Product NDC
71335-0171
11-digit product format
713350171
Labeler code
71335
Product ID
71335-0171_d6521e82-0348-4cbc-b828-b290ff9e31b1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dextroamphetamine saccharate, Amphetamine aspartate, Dextroamphetamine sulfate, and Amphetamine sulfate
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA040480
Marketing category
ANDA
Marketing start
2003-09-09
Substance
AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE
Active strength
2.5; 2.5; 2.5; 2.5 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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfate
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AMPHETAMINE ASPARTATE2.5 mg/1
AMPHETAMINE SULFATE2.5 mg/1
DEXTROAMPHETAMINE SACCHARATE2.5 mg/1
DEXTROAMPHETAMINE SULFATE2.5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiH527KAP6L5, 6DPV8NK46S, G83415V073, JJ768O327N
Rxcui541892

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71335-0171-12021-01-07C16284748780-19d75b9d0-5209-f424-e053-dadaa90a57ceDextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, Amphetamine Sulfate Tablets (Mixed Salts of a Single Entity Amphetamine Product) (CII)
71335-0171-22021-01-07C16284748780-19d75b9d0-5209-f424-e053-dadaa90a57ceDextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, Amphetamine Sulfate Tablets (Mixed Salts of a Single Entity Amphetamine Product) (CII)
71335-0171-32021-01-07C16284748780-19d75b9d0-5209-f424-e053-dadaa90a57ceDextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, Amphetamine Sulfate Tablets (Mixed Salts of a Single Entity Amphetamine Product) (CII)
71335-0171-42021-01-07C16284748780-19d75b9d0-5209-f424-e053-dadaa90a57ceDextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, Amphetamine Sulfate Tablets (Mixed Salts of a Single Entity Amphetamine Product) (CII)
71335-0171-52021-01-07C16284748780-19d75b9d0-5209-f424-e053-dadaa90a57ceDextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, Amphetamine Sulfate Tablets (Mixed Salts of a Single Entity Amphetamine Product) (CII)
71335-0171-12020-01-31C16284748780-19d75b9d0-5209-f424-e053-dadaa90a57ceDextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, Amphetamine Sulfate Tablets (Mixed Salts of a Single Entity Amphetamine Product) (CII)
71335-0171-22020-01-31C16284748780-19d75b9d0-5209-f424-e053-dadaa90a57ceDextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, Amphetamine Sulfate Tablets (Mixed Salts of a Single Entity Amphetamine Product) (CII)
71335-0171-32020-01-31C16284748780-19d75b9d0-5209-f424-e053-dadaa90a57ceDextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, Amphetamine Sulfate Tablets (Mixed Salts of a Single Entity Amphetamine Product) (CII)
71335-0171-42020-01-31C16284748780-19d75b9d0-5209-f424-e053-dadaa90a57ceDextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, Amphetamine Sulfate Tablets (Mixed Salts of a Single Entity Amphetamine Product) (CII)
71335-0171-52020-01-31C16284748780-19d75b9d0-5209-f424-e053-dadaa90a57ceDextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, Amphetamine Sulfate Tablets (Mixed Salts of a Single Entity Amphetamine Product) (CII)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-0171-1Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfate60 in 1 BOTTLETABLET6014
71335-0171-2Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfate30 in 1 BOTTLETABLET3014
71335-0171-3Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfate90 in 1 BOTTLETABLET9014
71335-0171-4Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfate120 in 1 BOTTLETABLET12014
71335-0171-5Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfate18 in 1 BOTTLETABLET1814

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-0171DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE, AND AMPHETAMINE SULFATE TABLET [BRYANT RANCH PREPACK]14Current NDC, Legacy NDC, 5 package rows20240510_b90efc87-f328-4501-b7bb-d059ac501f7f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
541892dextroamphetamine saccharate 2.5 MG / amphetamine aspartate 2.5 MG / dextroamphetamine sulfate 2.5 MG / amphetamine sulfate 2.5 MG Oral TabletPSNb90efc87-f328-4501-b7bb-d059ac501f7f14
541892amphetamine aspartate 2.5 MG / amphetamine sulfate 2.5 MG / dextroamphetamine saccharate 2.5 MG / dextroamphetamine sulfate 2.5 MG Oral TabletSCDb90efc87-f328-4501-b7bb-d059ac501f7f14
541892mixed amphetamine salts 10 MG Oral TabletSYb90efc87-f328-4501-b7bb-d059ac501f7f14

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-0171-17133501710160 TABLET in 1 BOTTLE (71335-0171-1) 60 tablet2021-12-270000-00-00NoNoCurrent
71335-0171-27133501710230 TABLET in 1 BOTTLE (71335-0171-2) 30 tablet2018-02-220000-00-00NoNoCurrent
71335-0171-37133501710390 TABLET in 1 BOTTLE (71335-0171-3) 90 tablet2021-12-270000-00-00NoNoCurrent
71335-0171-471335017104120 TABLET in 1 BOTTLE (71335-0171-4) 120 tablet2021-12-270000-00-00NoNoCurrent
71335-0171-57133501710518 TABLET in 1 BOTTLE (71335-0171-5) 18 tablet2021-12-270000-00-00NoNoCurrent