Home NDC 0480-3685 dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, and amphetamine sulfate
Product NDC 0480-3685
11-digit product format 004803685
Labeler code 0480
Product ID 0480-3685_071657b6-4f64-48c9-ac5f-4cb20d9b7430
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, and amphetamine sulfate
Dosage form CAPSULE, EXTENDED RELEASE
Route ORAL
Labeler Teva Pharmaceuticals, Inc.
Application ANDA210876
Marketing category ANDA
Marketing start 2023-10-10
Substance AMPHETAMINE ASPARTATE MONOHYDRATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE
Active strength 9.375; 9.375; 9.375; 9.375 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 2027-12-31
Current FDA listing Yes Additional Listing Data#
Finished product Yes
Brand name base dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, and amphetamine sulfate
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength AMPHETAMINE ASPARTATE MONOHYDRATE 9.375 mg/1 AMPHETAMINE SULFATE 9.375 mg/1 DEXTROAMPHETAMINE SACCHARATE 9.375 mg/1 DEXTROAMPHETAMINE SULFATE 9.375 mg/1
Harmonized Identifiers# Field, Values table Field Values Unii O1ZPV620O4, JJ768O327N, G83415V073, 6DPV8NK46S 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 0480-3685-01 dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, and amphetamine sulfate 100 in 1 BOTTLE CAPSULE, EXTENDED RELEASE 100 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0480-3685 DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE, AND AMPHETAMINE SULFATE CAPSULE, EXTENDED RELEASE [TEVA PHARMACEUTICALS, INC.] 5 Current NDC, 1 package rows 20250418_5e84ef60-3050-40d9-9f14-66b85d289e17.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 5e84ef60-3050-40d9-9f14-66b85d289e17 6 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 5e84ef60-3050-40d9-9f14-66b85d289e17 6 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 5e84ef60-3050-40d9-9f14-66b85d289e17 6 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 5e84ef60-3050-40d9-9f14-66b85d289e17 6 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 5e84ef60-3050-40d9-9f14-66b85d289e17 6 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 5e84ef60-3050-40d9-9f14-66b85d289e17 6 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 5e84ef60-3050-40d9-9f14-66b85d289e17 6 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 5e84ef60-3050-40d9-9f14-66b85d289e17 6 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 5e84ef60-3050-40d9-9f14-66b85d289e17 6 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 5e84ef60-3050-40d9-9f14-66b85d289e17 6 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 5e84ef60-3050-40d9-9f14-66b85d289e17 6 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 5e84ef60-3050-40d9-9f14-66b85d289e17 6
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 0480-3685-01 00480368501 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0480-3685-01) 2023-10-10 No No Historical