Home NDC 13107-072 Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate
Product NDC 13107-072
11-digit product format 131070072
Labeler code 13107
Product ID 13107-072_5962d880-9f18-4a57-8c95-ca0ec1e86f44
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate
Dosage form TABLET
Route ORAL
Labeler Aurolife Pharma, LLC
Application ANDA202424
Marketing category ANDA
Marketing start 2013-11-27
Substance AMPHETAMINE ASPARTATE MONOHYDRATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE
Active strength 3.75; 3.75; 3.75; 3.75 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 MONOHYDRATE 3.75 mg/1 AMPHETAMINE SULFATE 3.75 mg/1 DEXTROAMPHETAMINE SACCHARATE 3.75 mg/1 DEXTROAMPHETAMINE SULFATE 3.75 mg/1
Harmonized Identifiers# Field, Values table Field Values Unii O1ZPV620O4, JJ768O327N, G83415V073, 6DPV8NK46S Rxcui 541363, 541878, 541892, 577957, 577961, 687043, 1009145
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 13107-072-01 Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate 100 in 1 BOTTLE TABLET 100 14 13107-072-05 Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate 500 in 1 BOTTLE TABLET 500 14 13107-072-25 Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate 250 in 1 BOTTLE TABLET 250 14 13107-072-50 Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate 50 in 1 BOTTLE TABLET 50 14 13107-072-99 Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate 1000 in 1 BOTTLE TABLET 1000 14
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded AMPHETAMINE ASPARTATE MONOHYDRATE ACTIVE INGREDIENT O1ZPV620O4 DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE TABLET [AUROLIFE PHARMA, LLC] 4 AMPHETAMINE SULFATE ACTIVE INGREDIENT 6DPV8NK46S DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE TABLET [AUROLIFE PHARMA, LLC] 4 DEXTROAMPHETAMINE SACCHARATE ACTIVE INGREDIENT G83415V073 DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE TABLET [AUROLIFE PHARMA, LLC] 4 DEXTROAMPHETAMINE SULFATE ACTIVE INGREDIENT JJ768O327N DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE TABLET [AUROLIFE PHARMA, LLC] 4 AMPHETAMINE ACTIVE MOIETY CK833KGX7E DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE TABLET [AUROLIFE PHARMA, LLC] 4 DEXTROAMPHETAMINE ACTIVE MOIETY TZ47U051FI DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE TABLET [AUROLIFE PHARMA, LLC] 4 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE TABLET [AUROLIFE PHARMA, LLC] 4 COLLOIDAL SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE TABLET [AUROLIFE PHARMA, LLC] 4 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE TABLET [AUROLIFE PHARMA, LLC] 4 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE TABLET [AUROLIFE PHARMA, LLC] 4 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE TABLET [AUROLIFE PHARMA, LLC] 4 POVIDONE INACTIVE INGREDIENT FZ989GH94E DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE TABLET [AUROLIFE PHARMA, LLC] 4 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE TABLET [AUROLIFE PHARMA, LLC] 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 13107-072 DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE TABLET [AUROLIFE PHARMA, LLC] 13 Current NDC, Legacy NDC, 5 package rows 20250406_a582d57f-d191-4ca5-b105-585b2d8a0e3e.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 13107-072-01 13107007201 100 TABLET in 1 BOTTLE (13107-072-01) 100 tablet 2013-11-27 0000-00-00 No No Current 13107-072-05 13107007205 500 TABLET in 1 BOTTLE (13107-072-05) 500 tablet 2013-11-27 0000-00-00 No No Current 13107-072-25 13107007225 250 TABLET in 1 BOTTLE (13107-072-25) 250 tablet 2013-11-27 0000-00-00 No No Current 13107-072-50 13107007250 50 TABLET in 1 BOTTLE (13107-072-50) 50 tablet 2013-11-27 0000-00-00 No No Current 13107-072-99 13107007299 1000 TABLET in 1 BOTTLE (13107-072-99) 1000 tablet 2013-11-27 0000-00-00 No No Current