Home NDC 71335-0171
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 Ingredient Strength AMPHETAMINE ASPARTATE 2.5 mg/1 AMPHETAMINE SULFATE 2.5 mg/1 DEXTROAMPHETAMINE SACCHARATE 2.5 mg/1 DEXTROAMPHETAMINE SULFATE 2.5 mg/1
Harmonized Identifiers# Field, Values table Field Values Unii H527KAP6L5, 6DPV8NK46S, G83415V073, JJ768O327N Rxcui 541892
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# NDC, Effective, Action table NDC Effective Action Document Indexing SPL Related label 71335-0171-1 2021-01-07 C162847 48780-1 9d75b9d0-5209-f424-e053-dadaa90a57ce Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, Amphetamine Sulfate Tablets (Mixed Salts of a Single Entity Amphetamine Product) (CII) 71335-0171-2 2021-01-07 C162847 48780-1 9d75b9d0-5209-f424-e053-dadaa90a57ce Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, Amphetamine Sulfate Tablets (Mixed Salts of a Single Entity Amphetamine Product) (CII) 71335-0171-3 2021-01-07 C162847 48780-1 9d75b9d0-5209-f424-e053-dadaa90a57ce Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, Amphetamine Sulfate Tablets (Mixed Salts of a Single Entity Amphetamine Product) (CII) 71335-0171-4 2021-01-07 C162847 48780-1 9d75b9d0-5209-f424-e053-dadaa90a57ce Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, Amphetamine Sulfate Tablets (Mixed Salts of a Single Entity Amphetamine Product) (CII) 71335-0171-5 2021-01-07 C162847 48780-1 9d75b9d0-5209-f424-e053-dadaa90a57ce Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, Amphetamine Sulfate Tablets (Mixed Salts of a Single Entity Amphetamine Product) (CII) 71335-0171-1 2020-01-31 C162847 48780-1 9d75b9d0-5209-f424-e053-dadaa90a57ce Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, Amphetamine Sulfate Tablets (Mixed Salts of a Single Entity Amphetamine Product) (CII) 71335-0171-2 2020-01-31 C162847 48780-1 9d75b9d0-5209-f424-e053-dadaa90a57ce Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, Amphetamine Sulfate Tablets (Mixed Salts of a Single Entity Amphetamine Product) (CII) 71335-0171-3 2020-01-31 C162847 48780-1 9d75b9d0-5209-f424-e053-dadaa90a57ce Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, Amphetamine Sulfate Tablets (Mixed Salts of a Single Entity Amphetamine Product) (CII) 71335-0171-4 2020-01-31 C162847 48780-1 9d75b9d0-5209-f424-e053-dadaa90a57ce Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, Amphetamine Sulfate Tablets (Mixed Salts of a Single Entity Amphetamine Product) (CII) 71335-0171-5 2020-01-31 C162847 48780-1 9d75b9d0-5209-f424-e053-dadaa90a57ce Dextroamphetamine 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 NDC Product Description Form Quantity Strength SPL version 71335-0171-1 Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfate 60 in 1 BOTTLE TABLET 60 14 71335-0171-2 Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfate 30 in 1 BOTTLE TABLET 30 14 71335-0171-3 Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfate 90 in 1 BOTTLE TABLET 90 14 71335-0171-4 Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfate 120 in 1 BOTTLE TABLET 120 14 71335-0171-5 Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfate 18 in 1 BOTTLE TABLET 18 14
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 71335-0171 DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE, AND AMPHETAMINE SULFATE TABLET [BRYANT RANCH PREPACK] 14 Current NDC, Legacy NDC, 5 package rows 20240510_b90efc87-f328-4501-b7bb-d059ac501f7f.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 71335-0171-1 71335017101 60 TABLET in 1 BOTTLE (71335-0171-1) 60 tablet 2021-12-27 0000-00-00 No No Current 71335-0171-2 71335017102 30 TABLET in 1 BOTTLE (71335-0171-2) 30 tablet 2018-02-22 0000-00-00 No No Current 71335-0171-3 71335017103 90 TABLET in 1 BOTTLE (71335-0171-3) 90 tablet 2021-12-27 0000-00-00 No No Current 71335-0171-4 71335017104 120 TABLET in 1 BOTTLE (71335-0171-4) 120 tablet 2021-12-27 0000-00-00 No No Current 71335-0171-5 71335017105 18 TABLET in 1 BOTTLE (71335-0171-5) 18 tablet 2021-12-27 0000-00-00 No No Current