Home NDC 71335-1081 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 Ingredient Strength AMPHETAMINE ASPARTATE MONOHYDRATE 7.5 mg/1 AMPHETAMINE SULFATE 7.5 mg/1 DEXTROAMPHETAMINE SACCHARATE 7.5 mg/1 DEXTROAMPHETAMINE SULFATE 7.5 mg/1
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# NDC, Effective, Action table NDC Effective Action Document Indexing SPL Related label 71335-1081-1 2024-11-15 C162847 48780-1 1030e365-0a6e-111a-e063-dadaa90a10e2 Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets CII Rx Only 71335-1081-2 2024-11-15 C162847 48780-1 1030e365-0a6e-111a-e063-dadaa90a10e2 Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets CII Rx Only 71335-1081-3 2024-11-15 C162847 48780-1 1030e365-0a6e-111a-e063-dadaa90a10e2 Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets CII Rx Only 71335-1081-1 2024-01-30 C162847 48780-1 1030e365-0a6e-111a-e063-dadaa90a10e2 Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets CII Rx Only 71335-1081-2 2024-01-30 C162847 48780-1 1030e365-0a6e-111a-e063-dadaa90a10e2 Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets CII Rx Only 71335-1081-3 2024-01-30 C162847 48780-1 1030e365-0a6e-111a-e063-dadaa90a10e2 Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets CII Rx Only
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 71335-1081-1 Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate 60 in 1 BOTTLE TABLET 60 101 71335-1081-2 Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate 90 in 1 BOTTLE TABLET 90 101 71335-1081-3 Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate 30 in 1 BOTTLE TABLET 30 101
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 71335-1081 DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE TABLET [BRYANT RANCH PREPACK] 101 Current NDC, Legacy NDC, 3 package rows 20241116_ff1e5518-0aa6-4bc9-bc87-8a6a124bc95a.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 71335-1081-1 71335108101 60 TABLET in 1 BOTTLE (71335-1081-1) 60 tablet 2019-01-14 0000-00-00 No No Current 71335-1081-2 71335108102 90 TABLET in 1 BOTTLE (71335-1081-2) 90 tablet 2024-10-31 0000-00-00 No No Current 71335-1081-3 71335108103 30 TABLET in 1 BOTTLE (71335-1081-3) 30 tablet 2019-02-25 0000-00-00 No No Current