Home NDC 53489-568 NDC 53489-568 - Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfate This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.
Product NDC 53489-568
Package NDCs from labels 53489-568-01, 53489-568-03, 53489-568-05, 53489-568-10
Manufacturer Mutual Pharmaceutical Company
Effective date 2007-03-27
Current FDA listing Not matched in FDA.report NDC product tables DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 53489-568-01 Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfate 100 in 1 BOTTLE, PLASTIC TABLET 100 1 53489-568-03 Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfate 250 in 1 BOTTLE, PLASTIC TABLET 250 1 53489-568-05 Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfate 500 in 1 BOTTLE, PLASTIC TABLET 500 1 53489-568-10 Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfate 1000 in 1 BOTTLE, PLASTIC TABLET 1000 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 53489-568 DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE, AND AMPHETAMINE SULFATE (DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE, AND AMPHETAMINE SULFATE) TABLET [MUTUAL PHARMACEUTICAL COMPANY] 1 4 package rows 20070517_F0FC4960-8262-48E1-805C-DAE63FD045B0.zip
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded Amphetamine Aspartate ACTIVE INGREDIENT H527KAP6L5 DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE, AND AMPHETAMINE SULFATE (DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE, AND AMPHETAMINE SULFATE) TABLET [MUTUAL PHARMACEUTICAL COMPANY] 1 Amphetamine Sulfate ACTIVE INGREDIENT 6DPV8NK46S DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE, AND AMPHETAMINE SULFATE (DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE, AND AMPHETAMINE SULFATE) TABLET [MUTUAL PHARMACEUTICAL COMPANY] 1 Dextroamphetamine Saccharate ACTIVE INGREDIENT G83415V073 DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE, AND AMPHETAMINE SULFATE (DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE, AND AMPHETAMINE SULFATE) TABLET [MUTUAL PHARMACEUTICAL COMPANY] 1 Dextroamphetamine Sulfate ACTIVE INGREDIENT JJ768O327N DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE, AND AMPHETAMINE SULFATE (DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE, AND AMPHETAMINE SULFATE) TABLET [MUTUAL PHARMACEUTICAL COMPANY] 1 Amphetamine ACTIVE MOIETY CK833KGX7E DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE, AND AMPHETAMINE SULFATE (DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE, AND AMPHETAMINE SULFATE) TABLET [MUTUAL PHARMACEUTICAL COMPANY] 1 Dextroamphetamine ACTIVE MOIETY TZ47U051FI DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE, AND AMPHETAMINE SULFATE (DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE, AND AMPHETAMINE SULFATE) TABLET [MUTUAL PHARMACEUTICAL COMPANY] 1 Crospovidone INACTIVE INGREDIENT DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE, AND AMPHETAMINE SULFATE (DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE, AND AMPHETAMINE SULFATE) TABLET [MUTUAL PHARMACEUTICAL COMPANY] 1 D&C Yellow #10 Aluminum Lake INACTIVE INGREDIENT DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE, AND AMPHETAMINE SULFATE (DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE, AND AMPHETAMINE SULFATE) TABLET [MUTUAL PHARMACEUTICAL COMPANY] 1 FD&C Blue #1 Aluminum Lake INACTIVE INGREDIENT DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE, AND AMPHETAMINE SULFATE (DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE, AND AMPHETAMINE SULFATE) TABLET [MUTUAL PHARMACEUTICAL COMPANY] 1 magnesium stearate INACTIVE INGREDIENT 70097M6I30 DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE, AND AMPHETAMINE SULFATE (DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE, AND AMPHETAMINE SULFATE) TABLET [MUTUAL PHARMACEUTICAL COMPANY] 1 microcrystalline cellulose INACTIVE INGREDIENT DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE, AND AMPHETAMINE SULFATE (DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE, AND AMPHETAMINE SULFATE) TABLET [MUTUAL PHARMACEUTICAL COMPANY] 1 povidone INACTIVE INGREDIENT DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE, AND AMPHETAMINE SULFATE (DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE, AND AMPHETAMINE SULFATE) TABLET [MUTUAL PHARMACEUTICAL COMPANY] 1 pregelatinized starch INACTIVE INGREDIENT DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE, AND AMPHETAMINE SULFATE (DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE, AND AMPHETAMINE SULFATE) TABLET [MUTUAL PHARMACEUTICAL COMPANY] 1
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 2 of 2 · 25 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE Bryant Ranch Prepack 4804f3e0-2663-44f0-a10e-0baa56df9d69 2024-02-07 Boxed warning, Warnings, Adverse reactions Exact identifier rxcui: 1009145 Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfate DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE, AND AMPHETAMINE SULFATE Northstar Rx LLC facdf159-1d95-4981-a8ad-d82edcc14a0c 2024-01-11 Boxed warning, Warnings, Adverse reactions Exact identifier rxcui: 687043 rxcui: 1009145 rxcui: 541892 rxcui: 577957 rxcui: 541363 rxcui: 541878 rxcui: 577961 Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE Epic Pharma, LLC 1757e132-061d-4773-89ed-fdc77f69008f 2023-12-04 Boxed warning, Warnings, Adverse reactions Exact identifier rxcui: 541892 rxcui: 577957 rxcui: 541363 rxcui: 541878 rxcui: 577961 DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE, AND AMPHETAMINE SULFATE DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE, AND AMPHETAMINE SULFATE Camber Pharmaceuticals, Inc. 430cccec-1679-4225-8c86-92d746153b38 2023-09-28 Boxed warning, Warnings, Adverse reactions Exact identifier rxcui: 687043 rxcui: 1009145 rxcui: 541892 rxcui: 577957 rxcui: 541363 rxcui: 541878 rxcui: 577961 0D9F4440-9ECD-7EF5-D84E-EC41B763CAC4 F0FC4960-8262-48E1-805C-DAE63FD045B0 2007-03-27 Boxed warning, Warnings, Adverse reactions Exact identifier spl id: 0D9F4440-9ECD-7EF5-D84E-EC41B763CAC4 spl set id: F0FC4960-8262-48E1-805C-DAE63FD045B0
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.