Home NDC 70710-1189 Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate
Product NDC 70710-1189
11-digit product format 707101189
Labeler code 70710
Product ID 70710-1189_2516d493-1e13-46d9-b62c-d976a47228c6
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate
Dosage form CAPSULE, EXTENDED RELEASE
Route ORAL
Labeler Zydus Pharmaceuticals (USA) Inc.
Application ANDA210080
Marketing category ANDA
Marketing start 2016-12-30
Marketing end 0000-00-00
Substance DEXTROAMPHETAMINE SACCHARATE; AMPHETAMINE ASPARTATE MONOHYDRATE; DEXTROAMPHETAMINE SULFATE; AMPHETAMINE SULFATE
Active strength 8 mg/1; mg/1; mg/1; mg/1
Pharmacologic classes Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE]
DEA schedule CII
NDC exclude flag No
Listing certified through 2022-12-31
Current FDA listing Historical FDA.report record DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 70710-1189-1 Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate 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 70710-1189 DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE CAPSULE, EXTENDED RELEASE [ZYDUS PHARMACEUTICALS (USA) INC. ] 8 Legacy NDC, 1 package rows 20211218_a6eb907b-f830-4603-9899-e0ecf7d6d862.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 a6eb907b-f830-4603-9899-e0ecf7d6d862 8 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 a6eb907b-f830-4603-9899-e0ecf7d6d862 8 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 a6eb907b-f830-4603-9899-e0ecf7d6d862 8 861225 dextroamphetamine saccharate 5 MG / amphetamine aspartate 5 MG / dextroamphetamine sulfate 5 MG / amphetamine sulfate 5 MG 24HR Extended Release Oral Capsule PSN a6eb907b-f830-4603-9899-e0ecf7d6d862 8 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 a6eb907b-f830-4603-9899-e0ecf7d6d862 8 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 a6eb907b-f830-4603-9899-e0ecf7d6d862 8 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 a6eb907b-f830-4603-9899-e0ecf7d6d862 8 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 a6eb907b-f830-4603-9899-e0ecf7d6d862 8 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 a6eb907b-f830-4603-9899-e0ecf7d6d862 8 861225 24 HR amphetamine aspartate 5 MG / amphetamine sulfate 5 MG / dextroamphetamine saccharate 5 MG / dextroamphetamine sulfate 5 MG Extended Release Oral Capsule SCD a6eb907b-f830-4603-9899-e0ecf7d6d862 8 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 a6eb907b-f830-4603-9899-e0ecf7d6d862 8 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 a6eb907b-f830-4603-9899-e0ecf7d6d862 8 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 a6eb907b-f830-4603-9899-e0ecf7d6d862 8 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 a6eb907b-f830-4603-9899-e0ecf7d6d862 8 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 a6eb907b-f830-4603-9899-e0ecf7d6d862 8 861225 amphetamine aspartate 5 MG / amphetamine sulfate 5 MG / dextroamphetamine saccharate 5 MG / dextroamphetamine sulfate 5 MG 24 HR Extended Release Oral Capsule SY a6eb907b-f830-4603-9899-e0ecf7d6d862 8 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 a6eb907b-f830-4603-9899-e0ecf7d6d862 8 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 a6eb907b-f830-4603-9899-e0ecf7d6d862 8
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 70710-1189-1 70710118901 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (70710-1189-1) 2016-12-31 0000-00-00 No No Current