Home NDC 43975-279 Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate
Product NDC 43975-279
11-digit product format 439750279
Labeler code 43975
Product ID 43975-279_f25f7b30-b0dc-4d5c-b7d9-ddcb766ff559
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate
Dosage form CAPSULE, EXTENDED RELEASE
Route ORAL
Labeler ANI Pharmaceuticals, Inc.
Application ANDA205401
Marketing category ANDA
Marketing start 2020-03-16
Substance AMPHETAMINE DL-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
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 DL-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 JJ768O327N, 6DPV8NK46S, O1ZPV620O4, G83415V073 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 43975-279-10 Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate 100 in 1 BOTTLE CAPSULE, EXTENDED RELEASE 100 13
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 43975-279 DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE CAPSULE, EXTENDED RELEASE [ANI PHARMACEUTICALS, INC.] 10 Current NDC, Legacy NDC, 1 package rows 20250221_6438480f-1147-42b6-826d-4e1e1f8ff007.zip
DailyMed RxNorm Mappings# RxCUI, RxNorm string, TTY table RxCUI RxNorm string TTY DailyMed SPL version 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 a628ce9e-b216-44b1-9f07-f2aff97b0139 104 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 a628ce9e-b216-44b1-9f07-f2aff97b0139 104 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 a628ce9e-b216-44b1-9f07-f2aff97b0139 104 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 6438480f-1147-42b6-826d-4e1e1f8ff007 13 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 6438480f-1147-42b6-826d-4e1e1f8ff007 13 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 6438480f-1147-42b6-826d-4e1e1f8ff007 13 861225 dextroamphetamine saccharate 5 MG / amphetamine aspartate 5 MG / dextroamphetamine sulfate 5 MG / amphetamine sulfate 5 MG 24HR Extended Release Oral Capsule PSN 6438480f-1147-42b6-826d-4e1e1f8ff007 13 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 6438480f-1147-42b6-826d-4e1e1f8ff007 13 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 6438480f-1147-42b6-826d-4e1e1f8ff007 13 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 6438480f-1147-42b6-826d-4e1e1f8ff007 13 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 6438480f-1147-42b6-826d-4e1e1f8ff007 13 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 6438480f-1147-42b6-826d-4e1e1f8ff007 13 861225 24 HR amphetamine aspartate 5 MG / amphetamine sulfate 5 MG / dextroamphetamine saccharate 5 MG / dextroamphetamine sulfate 5 MG Extended Release Oral Capsule SCD 6438480f-1147-42b6-826d-4e1e1f8ff007 13 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 6438480f-1147-42b6-826d-4e1e1f8ff007 13 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 6438480f-1147-42b6-826d-4e1e1f8ff007 13 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 6438480f-1147-42b6-826d-4e1e1f8ff007 13 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 6438480f-1147-42b6-826d-4e1e1f8ff007 13 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 6438480f-1147-42b6-826d-4e1e1f8ff007 13 861225 amphetamine aspartate 5 MG / amphetamine sulfate 5 MG / dextroamphetamine saccharate 5 MG / dextroamphetamine sulfate 5 MG 24 HR Extended Release Oral Capsule SY 6438480f-1147-42b6-826d-4e1e1f8ff007 13 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 6438480f-1147-42b6-826d-4e1e1f8ff007 13 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 6438480f-1147-42b6-826d-4e1e1f8ff007 13
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 43975-279-10 43975027910 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (43975-279-10) 2020-03-16 0000-00-00 No No Current