Home NDC 0406-8885 Dextroamphetamine Saccharate and Amphetamine Aspartate and Dextroamphetamine Sulfate and Amphetamine Sulfate
Product NDC 0406-8885
11-digit product format 004068885
Labeler code 0406
Product ID 0406-8885_0d3fb5ba-ff79-4862-bc1d-45b8343e115b
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Dextroamphetamine Saccharate and Amphetamine Aspartate and Dextroamphetamine Sulfate and Amphetamine Sulfate
Dosage form TABLET
Route ORAL
Labeler SpecGx LLC
Application ANDA040440
Marketing category ANDA
Marketing start 2003-10-07
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 and Amphetamine Aspartate and 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 6DPV8NK46S, JJ768O327N, O1ZPV620O4, G83415V073 Rxcui 541363, 541878, 541892, 577957, 577961, 1009145
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0406-8885-01 Dextroamphetamine Saccharate and Amphetamine Aspartate and Dextroamphetamine Sulfate and Amphetamine Sulfate 100 in 1 BOTTLE TABLET 100 29
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded AMPHETAMINE ASPARTATE MONOHYDRATE ACTIVE INGREDIENT O1ZPV620O4 DEXTROAMPHETAMINE SACCHARATE AND AMPHETAMINE ASPARTATE AND DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE TABLET DEXTROAMPHETAMINE SACCHARATE AND AMPHETAMINE ASPARTATE AND DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE TABLET [MALLINCKRODT, INC.] 14 AMPHETAMINE SULFATE ACTIVE INGREDIENT 6DPV8NK46S DEXTROAMPHETAMINE SACCHARATE AND AMPHETAMINE ASPARTATE AND DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE TABLET DEXTROAMPHETAMINE SACCHARATE AND AMPHETAMINE ASPARTATE AND DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE TABLET [MALLINCKRODT, INC.] 14 DEXTROAMPHETAMINE SACCHARATE ACTIVE INGREDIENT G83415V073 DEXTROAMPHETAMINE SACCHARATE AND AMPHETAMINE ASPARTATE AND DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE TABLET DEXTROAMPHETAMINE SACCHARATE AND AMPHETAMINE ASPARTATE AND DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE TABLET [MALLINCKRODT, INC.] 14 DEXTROAMPHETAMINE SULFATE ACTIVE INGREDIENT JJ768O327N DEXTROAMPHETAMINE SACCHARATE AND AMPHETAMINE ASPARTATE AND DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE TABLET DEXTROAMPHETAMINE SACCHARATE AND AMPHETAMINE ASPARTATE AND DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE TABLET [MALLINCKRODT, INC.] 14 AMPHETAMINE ACTIVE MOIETY CK833KGX7E DEXTROAMPHETAMINE SACCHARATE AND AMPHETAMINE ASPARTATE AND DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE TABLET DEXTROAMPHETAMINE SACCHARATE AND AMPHETAMINE ASPARTATE AND DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE TABLET [MALLINCKRODT, INC.] 14 DEXTROAMPHETAMINE ACTIVE MOIETY TZ47U051FI DEXTROAMPHETAMINE SACCHARATE AND AMPHETAMINE ASPARTATE AND DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE TABLET DEXTROAMPHETAMINE SACCHARATE AND AMPHETAMINE ASPARTATE AND DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE TABLET [MALLINCKRODT, INC.] 14 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U DEXTROAMPHETAMINE SACCHARATE AND AMPHETAMINE ASPARTATE AND DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE TABLET DEXTROAMPHETAMINE SACCHARATE AND AMPHETAMINE ASPARTATE AND DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE TABLET [MALLINCKRODT, INC.] 14 POVIDONES INACTIVE INGREDIENT FZ989GH94E DEXTROAMPHETAMINE SACCHARATE AND AMPHETAMINE ASPARTATE AND DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE TABLET DEXTROAMPHETAMINE SACCHARATE AND AMPHETAMINE ASPARTATE AND DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE TABLET [MALLINCKRODT, INC.] 14 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 DEXTROAMPHETAMINE SACCHARATE AND AMPHETAMINE ASPARTATE AND DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE TABLET DEXTROAMPHETAMINE SACCHARATE AND AMPHETAMINE ASPARTATE AND DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE TABLET [MALLINCKRODT, INC.] 14 STEARIC ACID INACTIVE INGREDIENT 4ELV7Z65AP DEXTROAMPHETAMINE SACCHARATE AND AMPHETAMINE ASPARTATE AND DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE TABLET DEXTROAMPHETAMINE SACCHARATE AND AMPHETAMINE ASPARTATE AND DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE TABLET [MALLINCKRODT, INC.] 14
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0406-8885 DEXTROAMPHETAMINE SACCHARATE AND AMPHETAMINE ASPARTATE AND DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE TABLET DEXTROAMPHETAMINE SACCHARATE AND AMPHETAMINE ASPARTATE AND DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE TABLET [SPECGX LLC] 28 Current NDC, Legacy NDC, 1 package rows 20231104_72ddd1c9-ddbd-4c95-acd9-003189a353a3.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 0406-8885-01 00406888501 100 TABLET in 1 BOTTLE (0406-8885-01) 100 tablet 2003-10-07 0000-00-00 No No Current