Home NDC 57664-646 Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfate
Product NDC 57664-646
11-digit product format 576640646
Labeler code 57664
Product ID 57664-646_177c0583-addd-49cc-e063-6394a90aa6cc
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Dextroamphetamine saccharate, Amphetamine aspartate, Dextroamphetamine sulfate, and Amphetamine sulfate
Dosage form TABLET
Route ORAL
Labeler Sun Pharmaceutical Industries, Inc.
Application ANDA040480
Marketing category ANDA
Marketing start 2003-09-09
Substance AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE
Active strength 5; 5; 5; 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 5 mg/1 AMPHETAMINE SULFATE 5 mg/1 DEXTROAMPHETAMINE SACCHARATE 5 mg/1 DEXTROAMPHETAMINE SULFATE 5 mg/1
Harmonized Identifiers# Field, Values table Field Values Unii 6DPV8NK46S, G83415V073, JJ768O327N, H527KAP6L5 Rxcui 541363, 541878, 541892, 577957, 577961, 687043, 1009145
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 57664-646-08 Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfate 100 in 1 BOTTLE, PLASTIC TABLET 100 12
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded Amphetamine aspartate ACTIVE INGREDIENT H527KAP6L5 DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE, AND AMPHETAMINE SULFATE TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.] 4 Amphetamine sulfate ACTIVE INGREDIENT 6DPV8NK46S DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE, AND AMPHETAMINE SULFATE TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.] 4 Dextroamphetamine saccharate ACTIVE INGREDIENT G83415V073 DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE, AND AMPHETAMINE SULFATE TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.] 4 Dextroamphetamine sulfate ACTIVE INGREDIENT JJ768O327N DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE, AND AMPHETAMINE SULFATE TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.] 4 Amphetamine ACTIVE MOIETY CK833KGX7E DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE, AND AMPHETAMINE SULFATE TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.] 4 Dextroamphetamine ACTIVE MOIETY TZ47U051FI DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE, AND AMPHETAMINE SULFATE TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.] 4 cellulose, microcrystalline INACTIVE INGREDIENT OP1R32D61U DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE, AND AMPHETAMINE SULFATE TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.] 4 crospovidone INACTIVE INGREDIENT 68401960MK DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE, AND AMPHETAMINE SULFATE TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.] 4 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE, AND AMPHETAMINE SULFATE TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.] 4 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE, AND AMPHETAMINE SULFATE TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.] 4 magnesium stearate INACTIVE INGREDIENT 70097M6I30 DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE, AND AMPHETAMINE SULFATE TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.] 4 povidones INACTIVE INGREDIENT FZ989GH94E DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE, AND AMPHETAMINE SULFATE TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.] 4 starch, corn INACTIVE INGREDIENT O8232NY3SJ DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE, AND AMPHETAMINE SULFATE TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.] 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 57664-646 DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE, AND AMPHETAMINE SULFATE TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.] 12 Current NDC, Legacy NDC, 1 package rows 20240504_9af67219-9b37-45d0-ac52-647cbfacd296.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 57664-646-08 57664064608 100 TABLET in 1 BOTTLE, PLASTIC (57664-646-08) 100 tablet 2003-09-09 0000-00-00 No No Current