Home NDC 51407-553 Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate
Product NDC 51407-553
11-digit product format 514070553
Labeler code 51407
Product ID 51407-553_b5e90203-a411-9dad-e053-2995a90a13bf
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate
Dosage form CAPSULE, EXTENDED RELEASE
Route ORAL
Labeler Golden State Medical Supply, Inc.
Application ANDA212037
Marketing category ANDA
Marketing start 2019-12-11
Marketing end 0000-00-00
Substance DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE; AMPHETAMINE ASPARTATE MONOHYDRATE; 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 2021-12-31
Current FDA listing Historical FDA.report record DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 51407-553 DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE, AND AMPHETAMINE SULFATE CAPSULE, EXTENDED RELEASE [GOLDEN STATE MEDICAL SUPPLY, INC.] 3 Legacy NDC 20201209_b56d33c4-5359-e735-e053-2a95a90af67a.zip
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 51407-553-01 51407055301 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (51407-553-01) 2020-11-19 0000-00-00 No No Current