FDA.reportPublic FDA data

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

Product NDC
71335-0198
11-digit product format
713350198
Labeler code
71335
Product ID
71335-0198_467697a6-f3ef-4fb3-aa31-a72317689dc2
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
Marketing end
0000-00-00
Substance
DEXTROAMPHETAMINE SACCHARATE; AMPHETAMINE ASPARTATE MONOHYDRATE; DEXTROAMPHETAMINE SULFATE; AMPHETAMINE SULFATE
Active strength
5 mg/1; mg/1; mg/1; mg/1
Pharmacologic classes
Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE]
DEA schedule
CII
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71335-0198-12021-01-07C16284748780-19d75b9d0-5209-f424-e053-dadaa90a57ceDextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, Amphetamine Sulfate Tablets (Mixed Salts of a Single Entity Amphetamine Product) (CII)
71335-0198-22021-01-07C16284748780-19d75b9d0-5209-f424-e053-dadaa90a57ceDextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, Amphetamine Sulfate Tablets (Mixed Salts of a Single Entity Amphetamine Product) (CII)
71335-0198-32021-01-07C16284748780-19d75b9d0-5209-f424-e053-dadaa90a57ceDextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, Amphetamine Sulfate Tablets (Mixed Salts of a Single Entity Amphetamine Product) (CII)
71335-0198-42021-01-07C16284748780-19d75b9d0-5209-f424-e053-dadaa90a57ceDextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, Amphetamine Sulfate Tablets (Mixed Salts of a Single Entity Amphetamine Product) (CII)
71335-0198-52021-01-07C16284748780-19d75b9d0-5209-f424-e053-dadaa90a57ceDextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, Amphetamine Sulfate Tablets (Mixed Salts of a Single Entity Amphetamine Product) (CII)
71335-0198-12020-01-31C16284748780-19d75b9d0-5209-f424-e053-dadaa90a57ceDextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, Amphetamine Sulfate Tablets (Mixed Salts of a Single Entity Amphetamine Product) (CII)
71335-0198-22020-01-31C16284748780-19d75b9d0-5209-f424-e053-dadaa90a57ceDextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, Amphetamine Sulfate Tablets (Mixed Salts of a Single Entity Amphetamine Product) (CII)
71335-0198-32020-01-31C16284748780-19d75b9d0-5209-f424-e053-dadaa90a57ceDextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, Amphetamine Sulfate Tablets (Mixed Salts of a Single Entity Amphetamine Product) (CII)
71335-0198-42020-01-31C16284748780-19d75b9d0-5209-f424-e053-dadaa90a57ceDextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, Amphetamine Sulfate Tablets (Mixed Salts of a Single Entity Amphetamine Product) (CII)
71335-0198-52020-01-31C16284748780-19d75b9d0-5209-f424-e053-dadaa90a57ceDextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, Amphetamine Sulfate Tablets (Mixed Salts of a Single Entity Amphetamine Product) (CII)

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-0198-17133501980160 TABLET in 1 BOTTLE (71335-0198-1) 60 tablet2016-06-070000-00-00NoNoCurrent
71335-0198-27133501980290 TABLET in 1 BOTTLE (71335-0198-2) 90 tablet2016-06-070000-00-00NoNoCurrent
71335-0198-37133501980330 TABLET in 1 BOTTLE (71335-0198-3) 30 tablet2016-06-070000-00-00NoNoCurrent
71335-0198-471335019804120 TABLET in 1 BOTTLE (71335-0198-4) 120 tablet2016-06-070000-00-00NoNoCurrent
71335-0198-57133501980518 TABLET in 1 BOTTLE (71335-0198-5) 18 tablet2016-06-070000-00-00NoNoCurrent