Home NDC 0406-0804 Mixed Salts of a Single-Entity Amphetamine Product
Product NDC 0406-0804
11-digit product format 004060804
Labeler code 0406
Product ID 0406-0804_03d41c88-9c50-4406-91ba-7a086cad0366
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE, AMPHETAMINE SULFATE
Dosage form CAPSULE, EXTENDED RELEASE
Route ORAL
Labeler SpecGx LLC
Application ANDA211546
Marketing category ANDA
Marketing start 2023-11-01
Substance AMPHETAMINE ASPARTATE MONOHYDRATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE
Active strength 12.5; 12.5; 12.5; 12.5 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 Mixed Salts of a Single-Entity Amphetamine Product
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength AMPHETAMINE ASPARTATE MONOHYDRATE 12.5 mg/1 AMPHETAMINE SULFATE 12.5 mg/1 DEXTROAMPHETAMINE SACCHARATE 12.5 mg/1 DEXTROAMPHETAMINE SULFATE 12.5 mg/1
Harmonized Identifiers# Field, Values table Field Values Unii JJ768O327N, 6DPV8NK46S, O1ZPV620O4, G83415V073 Rxcui 1927610, 1927617, 1927630, 1927637
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0406-0804-01 Mixed Salts of a Single-Entity Amphetamine Product 100 in 1 BOTTLE CAPSULE, EXTENDED RELEASE 100 8
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0406-0804 MIXED SALTS OF A SINGLE-ENTITY AMPHETAMINE PRODUCT (DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE, AMPHETAMINE SULFATE) CAPSULE, EXTENDED RELEASE [SPECGX LLC] 8 Current NDC, 1 package rows 20240724_e1b21fd4-8d0b-4e54-a35d-8ad84a7caa78.zip
DailyMed RxNorm Mappings# RxCUI, RxNorm string, TTY table RxCUI RxNorm string TTY DailyMed SPL version 1927610 amphetamine aspartate 12.5 MG / amphetamine sulfate 12.5 MG / dextroamphetamine saccharate 12.5 MG / dextroamphetamine sulfate 12.5 MG 3-Bead 24HR Extended Release Oral Capsule PSN e1b21fd4-8d0b-4e54-a35d-8ad84a7caa78 8 1927630 amphetamine aspartate 3.125 MG / amphetamine sulfate 3.125 MG / dextroamphetamine saccharate 3.125 MG / dextroamphetamine sulfate 3.125 MG 3-Bead 24HR Extended Release Oral Capsule PSN e1b21fd4-8d0b-4e54-a35d-8ad84a7caa78 8 1927617 amphetamine aspartate 6.25 MG / amphetamine sulfate 6.25 MG / dextroamphetamine saccharate 6.25 MG / dextroamphetamine sulfate 6.25 MG 3-Bead 24HR Extended Release Oral Capsule PSN e1b21fd4-8d0b-4e54-a35d-8ad84a7caa78 8 1927637 amphetamine aspartate 9.375 MG / amphetamine sulfate 9.375 MG / dextroamphetamine saccharate 9.375 MG / dextroamphetamine sulfate 9.375 MG 3-Bead 24HR Extended Release Oral Capsule PSN e1b21fd4-8d0b-4e54-a35d-8ad84a7caa78 8 1927610 3-Bead 24 HR amphetamine aspartate 12.5 MG / amphetamine sulfate 12.5 MG / dextroamphetamine saccharate 12.5 MG / dextroamphetamine sulfate 12.5 MG Extended Release Oral Capsule SCD e1b21fd4-8d0b-4e54-a35d-8ad84a7caa78 8 1927630 3-Bead 24 HR amphetamine aspartate 3.125 MG / amphetamine sulfate 3.125 MG / dextroamphetamine saccharate 3.125 MG / dextroamphetamine sulfate 3.125 MG Extended Release Oral Capsule SCD e1b21fd4-8d0b-4e54-a35d-8ad84a7caa78 8 1927617 3-Bead 24 HR amphetamine aspartate 6.25 MG / amphetamine sulfate 6.25 MG / dextroamphetamine saccharate 6.25 MG / dextroamphetamine sulfate 6.25 MG Extended Release Oral Capsule SCD e1b21fd4-8d0b-4e54-a35d-8ad84a7caa78 8 1927637 3-Bead 24 HR amphetamine aspartate 9.375 MG / amphetamine sulfate 9.375 MG / dextroamphetamine saccharate 9.375 MG / dextroamphetamine sulfate 9.375 MG Extended Release Oral Capsule SCD e1b21fd4-8d0b-4e54-a35d-8ad84a7caa78 8 1927610 amphetamine aspartate 12.5 MG / amphetamine sulfate 12.5 MG / dextroamphetamine saccharate 12.5 MG / dextroamphetamine sulfate 12.5 MG 3-Bead 24HR Extended Release Oral Capsule SY e1b21fd4-8d0b-4e54-a35d-8ad84a7caa78 8 1927630 amphetamine aspartate 3.125 MG / amphetamine sulfate 3.125 MG / dextroamphetamine saccharate 3.125 MG / dextroamphetamine sulfate 3.125 MG 3-Bead 24HR Extended Release Oral Capsule SY e1b21fd4-8d0b-4e54-a35d-8ad84a7caa78 8 1927617 amphetamine aspartate 6.25 MG / amphetamine sulfate 6.25 MG / dextroamphetamine saccharate 6.25 MG / dextroamphetamine sulfate 6.25 MG 3-Bead 24HR Extended Release Oral Capsule SY e1b21fd4-8d0b-4e54-a35d-8ad84a7caa78 8 1927637 amphetamine aspartate 9.375 MG / amphetamine sulfate 9.375 MG / dextroamphetamine saccharate 9.375 MG / dextroamphetamine sulfate 9.375 MG 3-Bead 24HR Extended Release Oral Capsule SY e1b21fd4-8d0b-4e54-a35d-8ad84a7caa78 8
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 0406-0804-01 00406080401 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0406-0804-01) 2023-11-01 No No Historical