Home NDC 35573-466 Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate
Product NDC 35573-466
11-digit product format 355730466
Labeler code 35573
Product ID 35573-466_01fe666a-d04e-4dce-af71-8db45bbde653
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate
Dosage form CAPSULE, EXTENDED RELEASE
Route ORAL
Labeler Burel Pharmaceuticals, LLC
Application ANDA212037
Marketing category ANDA
Marketing start 2019-12-16
Marketing end 2028-02-29
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
Current FDA listing Yes Additional Listing Data#
Finished product Yes
Brand name base Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate 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 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 35573-466-02 Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate 100 in 1 BOTTLE CAPSULE, EXTENDED RELEASE 100 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 35573-466 DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE, AND AMPHETAMINE SULFATE CAPSULE, EXTENDED RELEASE [BUREL PHARMACEUTICALS, LLC] 2 Current NDC, 1 package rows 20240515_bcdd2fe2-d0de-4a28-aced-40ac9ce5122d.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 bcdd2fe2-d0de-4a28-aced-40ac9ce5122d 3 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 bcdd2fe2-d0de-4a28-aced-40ac9ce5122d 3 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 bcdd2fe2-d0de-4a28-aced-40ac9ce5122d 3 861225 dextroamphetamine saccharate 5 MG / amphetamine aspartate 5 MG / dextroamphetamine sulfate 5 MG / amphetamine sulfate 5 MG 24HR Extended Release Oral Capsule PSN bcdd2fe2-d0de-4a28-aced-40ac9ce5122d 3 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 bcdd2fe2-d0de-4a28-aced-40ac9ce5122d 3 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 bcdd2fe2-d0de-4a28-aced-40ac9ce5122d 3 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 bcdd2fe2-d0de-4a28-aced-40ac9ce5122d 3 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 bcdd2fe2-d0de-4a28-aced-40ac9ce5122d 3 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 bcdd2fe2-d0de-4a28-aced-40ac9ce5122d 3 861225 24 HR amphetamine aspartate 5 MG / amphetamine sulfate 5 MG / dextroamphetamine saccharate 5 MG / dextroamphetamine sulfate 5 MG Extended Release Oral Capsule SCD bcdd2fe2-d0de-4a28-aced-40ac9ce5122d 3 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 bcdd2fe2-d0de-4a28-aced-40ac9ce5122d 3 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 bcdd2fe2-d0de-4a28-aced-40ac9ce5122d 3 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 bcdd2fe2-d0de-4a28-aced-40ac9ce5122d 3 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 bcdd2fe2-d0de-4a28-aced-40ac9ce5122d 3 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 bcdd2fe2-d0de-4a28-aced-40ac9ce5122d 3 861225 amphetamine aspartate 5 MG / amphetamine sulfate 5 MG / dextroamphetamine saccharate 5 MG / dextroamphetamine sulfate 5 MG 24 HR Extended Release Oral Capsule SY bcdd2fe2-d0de-4a28-aced-40ac9ce5122d 3 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 bcdd2fe2-d0de-4a28-aced-40ac9ce5122d 3 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 bcdd2fe2-d0de-4a28-aced-40ac9ce5122d 3
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 35573-466-02 35573046602 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (35573-466-02) 2019-12-16 2028-02-29 No No Historical