Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate

Product NDC
71335-1081
11-digit product format
713351081
Labeler code
71335
Product ID
71335-1081_c6671273-c88f-4bba-bed1-59d45d395a8d
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
ANDA202424
Marketing category
ANDA
Marketing start
2013-11-27
Substance
AMPHETAMINE ASPARTATE MONOHYDRATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE
Active strength
7.5; 7.5; 7.5; 7.5 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
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AMPHETAMINE ASPARTATE MONOHYDRATE7.5 mg/1
AMPHETAMINE SULFATE7.5 mg/1
DEXTROAMPHETAMINE SACCHARATE7.5 mg/1
DEXTROAMPHETAMINE SULFATE7.5 mg/1

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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-1081-1Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate60 in 1 BOTTLETABLET60101
71335-1081-2Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate90 in 1 BOTTLETABLET90101
71335-1081-3Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate30 in 1 BOTTLETABLET30101

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1081DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE TABLET [BRYANT RANCH PREPACK]101Current NDC, Legacy NDC, 3 package rows20241116_ff1e5518-0aa6-4bc9-bc87-8a6a124bc95a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
541363dextroamphetamine saccharate 7.5 MG / amphetamine aspartate 7.5 MG / dextroamphetamine sulfate 7.5 MG / amphetamine sulfate 7.5 MG Oral TabletPSNff1e5518-0aa6-4bc9-bc87-8a6a124bc95a101
541363amphetamine aspartate 7.5 MG / amphetamine sulfate 7.5 MG / dextroamphetamine saccharate 7.5 MG / dextroamphetamine sulfate 7.5 MG Oral TabletSCDff1e5518-0aa6-4bc9-bc87-8a6a124bc95a101
541363mixed amphetamine salts 30 MG Oral TabletSYff1e5518-0aa6-4bc9-bc87-8a6a124bc95a101

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-1081-17133510810160 TABLET in 1 BOTTLE (71335-1081-1) 60 tablet2019-01-140000-00-00NoNoCurrent
71335-1081-27133510810290 TABLET in 1 BOTTLE (71335-1081-2) 90 tablet2024-10-310000-00-00NoNoCurrent
71335-1081-37133510810330 TABLET in 1 BOTTLE (71335-1081-3) 30 tablet2019-02-250000-00-00NoNoCurrent