FDA.reportPublic FDA data

NDC 57319-528 - AMINO ACID ORAL

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
57319-528
Package NDCs from labels
57319-528-04
Manufacturer
Clipper Distributing Company, LLC | Sparhawk Laboratories, Inc.
Effective date
2024-06-05
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
AMINO ACID ORAL SOLUTIONClipper Distributing Company, LLC | Sparhawk Laboratories, Inc.2024-06-05OTC ANIMAL DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57319-528-04AMINO ACID ORAL500 mL in 1 BOTTLESOLUTION5001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57319-528AMINO ACID ORAL (AMINO ACID) SOLUTION [CLIPPER DISTRIBUTING COMPANY, LLC]11 package rows20240606_9f2f4fa6-8725-4c70-bab0-b520fd5c8f5e.zip

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 25 of 36 · 703 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Theraworx Relief Muscle Cramp and Spasm ReliefMAGNESIUM SULFATE HEPTAHYDRATEAVADIM HOLDINGS, INCde5c58fb-2ce7-4beb-bc37-26d7cf0e8a782024-06-18WarningsExact identifier
unii: SK47B8698T
KALI MURKALI MURRxhomeo Private Limited d.b.a. Rxhomeo, Inc1a3522bc-3d43-ea96-e063-6394a90aa2cc2024-06-06WarningsExact identifier
unii: 660YQ98I10
Potassium Chloride Extended-releasePOTASSIUM CHLORIDE EXTENDED-RELEASEProficient Rx LPc53d1db5-1c9e-4289-a2a2-961e0dd56f322024-06-01Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
POTASSIUM CHLORIDEPOTASSIUM CHLORIDEBryant Ranch Prepackd396477a-6b15-4782-9c85-b9663b83c4842024-05-23Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
Potassium Chloride in Lactated Ringers and DextrosePOTASSIUM CHLORIDE, SODIUM CHLORIDE, CALCIUM CHLORIDE, SODIUM LACTATE, AND DEXTROSE MONOHYDRATEFresenius Kabi USA, LLCdbed53b7-0109-4561-8342-0178ec8c64b02024-05-22Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
unii: LX22YL083G
Lactated Ringers and DextroseSODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, CALCIUM CHLORIDE, AND DEXTROSE MONOHYDRATEFresenius Kabi USA, LLC1b912c7e-f005-4af4-b683-0834409642492024-05-22Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
unii: LX22YL083G
POTASSIUM CHLORIDEPOTASSIUM CHLORIDEXLCare Pharmaceuticals, Inc.7fd82f08-8ad0-4ee2-8eb6-5c973f98baee2024-05-21Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
Potassium ChloridePOTASSIUM CHLORIDEBryant Ranch Prepack7a220e87-ff72-417b-bc45-90a37b7f2aa62024-05-21Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
POTASSIUM CHLORIDEPOTASSIUM CHLORIDECamber Pharmaceuticals, Inc.b1e827aa-b2fb-4fa5-984d-ddd94338ff532024-05-14Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
Sodium AcetateSODIUM ACETATEHikma Pharmaceuticals USA Inc.8a338072-6f1e-460c-b9ec-59cef4f3f5972024-05-08Warnings, Adverse reactionsExact identifier
unii: NVG71ZZ7P0
Sodium AcetateSODIUM ACETATEHikma Pharmaceuticals USA Inc.7ee23a1c-bc99-4ff6-b2e7-d2aa427445532024-05-08Warnings, Adverse reactionsExact identifier
unii: NVG71ZZ7P0
Potassium ChloridePOTASSIUM CHLORIDE, DEXTROSE MONOHYDRATEFresenius Kabi USA, LLC55d9ae37-4553-47e7-a2e3-86b48b5227cd2024-05-08Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
unii: LX22YL083G
Potassium Chloride in Dextrose and Sodium ChlorideDEXTROSE MONOHYDRATE, SODIUM CHLORIDE, AND POTASSIUM CHLORIDEFresenius Kabi USA, LLCf0cc6713-4d47-49be-8116-901c99002b6b2024-05-07Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
unii: LX22YL083G
Lactated RingersSODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, AND CALCIUM CHLORIDEAsclemed USA, Inc.f4ca52c6-9f90-7bb5-e053-2a95a90ae3ff2024-05-07Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
Potassium Chloride in Dextrose and Sodium ChlorideDEXTROSE MONOHYDRATE, SODIUM CHLORIDE, AND POTASSIUM CHLORIDEFresenius Kabi USA, LLC97001218-086c-430a-9e0d-6c7031c91d942024-05-06Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
unii: LX22YL083G
Potassium Chloride in Dextrose and Sodium ChlorideDEXTROSE MONOHYDRATE, SODIUM CHLORIDE, AND POTASSIUM CHLORIDEFresenius Kabi USA, LLCfe5b5182-c859-4c74-b2e0-467be5b2e3292024-05-06Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
unii: LX22YL083G
Potassium Chloride in Sodium ChlorideSODIUM CHLORIDE AND POTASSIUM CHLORIDEFresenius Kabi USA, LLCc2467d57-cd2d-4409-bcc0-50128bd01bba2024-04-30Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
LACTATED RINGERSSODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, CALCIUM CHLORIDEFresenius Kabi USA, LLC7a723a23-3bc1-4f69-b82f-d06a35dc68d62024-04-24Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
DextroseDEXTROSE MONOHYDRATEFresenius Kabi USA, LLCf2379398-a07b-417e-a022-f7b41f9620672024-04-24Warnings, Adverse reactionsExact identifier
unii: LX22YL083G
magnesium sulfateMAGNESIUM SULFATE HEPTAHYDRATEFresenius Kabi USA, LLCfef9e18c-5210-4090-b564-4950ebe461c02024-04-24Warnings, Adverse reactionsExact identifier
unii: SK47B8698T

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.