Home NDC 0406-8952 Mixed Salts of a Single Entity Amphetamine Product
Product NDC 0406-8952
11-digit product format 004068952
Labeler code 0406
Product ID 0406-8952_d35f2f82-b0de-4f2a-a740-3d95c364cd7b
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 ANDA211547
Marketing category ANDA
Marketing start 2019-04-22
Substance AMPHETAMINE ASPARTATE MONOHYDRATE; 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 Mixed Salts of a Single Entity Amphetamine Product
Brand name suffix XR
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength AMPHETAMINE ASPARTATE MONOHYDRATE 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 O1ZPV620O4, JJ768O327N, G83415V073, 6DPV8NK46S Rxcui 861221, 861223, 861225, 861227, 861232, 861237
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0406-8952-01 Mixed Salts of a Single Entity Amphetamine ProductXR 100 in 1 BOTTLE CAPSULE, EXTENDED RELEASE 100 16
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0406-8952 MIXED SALTS OF A SINGLE ENTITY AMPHETAMINE PRODUCT XR (DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE, AMPHETAMINE SULFATE) CAPSULE, EXTENDED RELEASE [SPECGX LLC] 15 Current NDC, Legacy NDC, 1 package rows 20240724_60a2834c-38a2-480e-b89c-563e9cf0c9c3.zip
DailyMed RxNorm Mappings# RxCUI, RxNorm string, TTY table RxCUI RxNorm string TTY DailyMed SPL version 861237 dextroamphetamine saccharate 1.25 MG / amphetamine aspartate 1.25 MG / dextroamphetamine sulfate 1.25 MG / amphetamine sulfate 1.25 MG 24HR Extended Release Oral Capsule PSN 60a2834c-38a2-480e-b89c-563e9cf0c9c3 16 861221 dextroamphetamine saccharate 2.5 MG / amphetamine aspartate 2.5 MG / dextroamphetamine sulfate 2.5 MG / amphetamine sulfate 2.5 MG 24HR Extended Release Oral Capsule PSN 60a2834c-38a2-480e-b89c-563e9cf0c9c3 16 861223 dextroamphetamine saccharate 3.75 MG / amphetamine aspartate 3.75 MG / dextroamphetamine sulfate 3.75 MG / amphetamine sulfate 3.75 MG 24HR Extended Release Oral Capsule PSN 60a2834c-38a2-480e-b89c-563e9cf0c9c3 16 861225 dextroamphetamine saccharate 5 MG / amphetamine aspartate 5 MG / dextroamphetamine sulfate 5 MG / amphetamine sulfate 5 MG 24HR Extended Release Oral Capsule PSN 60a2834c-38a2-480e-b89c-563e9cf0c9c3 16 861227 dextroamphetamine saccharate 6.25 MG / amphetamine aspartate 6.25 MG / dextroamphetamine sulfate 6.25 MG / amphetamine sulfate 6.25 MG 24HR Extended Release Oral Capsule PSN 60a2834c-38a2-480e-b89c-563e9cf0c9c3 16 861232 dextroamphetamine saccharate 7.5 MG / amphetamine aspartate 7.5 MG / dextroamphetamine sulfate 7.5 MG / amphetamine sulfate 7.5 MG 24HR Extended Release Oral Capsule PSN 60a2834c-38a2-480e-b89c-563e9cf0c9c3 16 861237 24 HR amphetamine aspartate 1.25 MG / amphetamine sulfate 1.25 MG / dextroamphetamine saccharate 1.25 MG / dextroamphetamine sulfate 1.25 MG Extended Release Oral Capsule SCD 60a2834c-38a2-480e-b89c-563e9cf0c9c3 16 861221 24 HR amphetamine aspartate 2.5 MG / amphetamine sulfate 2.5 MG / dextroamphetamine saccharate 2.5 MG / dextroamphetamine sulfate 2.5 MG Extended Release Oral Capsule SCD 60a2834c-38a2-480e-b89c-563e9cf0c9c3 16 861223 24 HR amphetamine aspartate 3.75 MG / amphetamine sulfate 3.75 MG / dextroamphetamine saccharate 3.75 MG / dextroamphetamine sulfate 3.75 MG Extended Release Oral Capsule SCD 60a2834c-38a2-480e-b89c-563e9cf0c9c3 16 861225 24 HR amphetamine aspartate 5 MG / amphetamine sulfate 5 MG / dextroamphetamine saccharate 5 MG / dextroamphetamine sulfate 5 MG Extended Release Oral Capsule SCD 60a2834c-38a2-480e-b89c-563e9cf0c9c3 16 861227 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 60a2834c-38a2-480e-b89c-563e9cf0c9c3 16 861232 24 HR amphetamine aspartate 7.5 MG / amphetamine sulfate 7.5 MG / dextroamphetamine saccharate 7.5 MG / dextroamphetamine sulfate 7.5 MG Extended Release Oral Capsule SCD 60a2834c-38a2-480e-b89c-563e9cf0c9c3 16 861237 amphetamine aspartate 1.25 MG / amphetamine sulfate 1.25 MG / dextroamphetamine saccharate 1.25 MG / dextroamphetamine sulfate 1.25 MG 24 HR Extended Release Oral Capsule SY 60a2834c-38a2-480e-b89c-563e9cf0c9c3 16 861221 amphetamine aspartate 2.5 MG / amphetamine sulfate 2.5 MG / dextroamphetamine saccharate 2.5 MG / dextroamphetamine sulfate 2.5 MG 24 HR Extended Release Oral Capsule SY 60a2834c-38a2-480e-b89c-563e9cf0c9c3 16 861223 amphetamine aspartate 3.75 MG / amphetamine sulfate 3.75 MG / dextroamphetamine saccharate 3.75 MG / dextroamphetamine sulfate 3.75 MG 24 HR Extended Release Oral Capsule SY 60a2834c-38a2-480e-b89c-563e9cf0c9c3 16 861225 amphetamine aspartate 5 MG / amphetamine sulfate 5 MG / dextroamphetamine saccharate 5 MG / dextroamphetamine sulfate 5 MG 24 HR Extended Release Oral Capsule SY 60a2834c-38a2-480e-b89c-563e9cf0c9c3 16 861227 amphetamine aspartate 6.25 MG / amphetamine sulfate 6.25 MG / dextroamphetamine saccharate 6.25 MG / dextroamphetamine sulfate 6.25 MG 24 HR Extended Release Oral Capsule SY 60a2834c-38a2-480e-b89c-563e9cf0c9c3 16 861232 amphetamine aspartate 7.5 MG / amphetamine sulfate 7.5 MG / dextroamphetamine saccharate 7.5 MG / dextroamphetamine sulfate 7.5 MG 24 HR Extended Release Oral Capsule SY 60a2834c-38a2-480e-b89c-563e9cf0c9c3 16
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 0406-8952-01 00406895201 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0406-8952-01) 2019-04-22 0000-00-00 No No Current