FDA.reportPublic FDA data

NDC 50090-5809-01 - Pravastatin Sodium

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
50090-5809
Requested NDC
50090-5809-01
Package NDCs from labels
50090-5809-0, 50090-5809-1, 50090-5809-01
Manufacturer
A-S Medication Solutions
Effective date
2023-02-06
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Pravastatin Sodium - A-S Medication SolutionsA-S Medication Solutions2023-02-06HUMAN PRESCRIPTION DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
50090-5809-02023-02-07These highlights do not include all the information needed to use PRAVASTATIN SODIUM TABLETS safely and effectively. See full prescribing information for PRAVASTATIN SODIUM TABLETS. PRAVASTATIN SODIUM tablets, for oral use Initial U.S. Approval: 1991
50090-5809-12023-02-07These highlights do not include all the information needed to use PRAVASTATIN SODIUM TABLETS safely and effectively. See full prescribing information for PRAVASTATIN SODIUM TABLETS. PRAVASTATIN SODIUM tablets, for oral use Initial U.S. Approval: 1991
50090-5809-02023-01-30These highlights do not include all the information needed to use PRAVASTATIN SODIUM TABLETS safely and effectively. See full prescribing information for PRAVASTATIN SODIUM TABLETS. PRAVASTATIN SODIUM tablets, for oral use Initial U.S. Approval: 1991
50090-5809-12023-01-30These highlights do not include all the information needed to use PRAVASTATIN SODIUM TABLETS safely and effectively. See full prescribing information for PRAVASTATIN SODIUM TABLETS. PRAVASTATIN SODIUM tablets, for oral use Initial U.S. Approval: 1991

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-5809-0Pravastatin Sodium30 in 1 BOTTLETABLET303
50090-5809-1Pravastatin Sodium90 in 1 BOTTLETABLET903

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-5809PRAVASTATIN SODIUM TABLET [A-S MEDICATION SOLUTIONS]3Current NDC, Legacy NDC, 2 package rows20230208_3a08fa97-24c3-4a4a-a0aa-26e50cbfc52d.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-5809-0EA - Each50090-5809ddc4eb01-2820-4f41-b8cb-24cb3693efe012022-07-06
50090-5809-1EA - Each50090-580939c58343-016b-4b14-98e1-85bf73e4353f12022-07-06

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 34 of 39 · 764 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Pravastatin SodiumPRAVASTATIN SODIUMA-S Medication Solutions3a08fa97-24c3-4a4a-a0aa-26e50cbfc52d2023-02-06Warnings, Adverse reactionsExact identifier
application number: ANDA077987
ndc (package): 50090-5809-1
ndc (package): 50090-5809-0
ndc (product): 50090-5809
ndc11 (package): 50090580901
rxcui: 904481
spl id: f22b7db7-372b-4cb8-a08f-7637e0fa46e0
spl set id: 3a08fa97-24c3-4a4a-a0aa-26e50cbfc52d
unii: 3M8608UQ61
SiliceaSILICON DIOXIDEBoiron86d2db09-9c46-37f7-e053-2a91aa0a326f2023-01-23Exact identifier
unii: ETJ7Z6XBU4
SiliceaSILICON DIOXIDEBoiron86d3be33-b50e-e649-e053-2a91aa0acfc52023-01-23Exact identifier
unii: ETJ7Z6XBU4
SiliceaSILICON DIOXIDEBoiron86d3be33-b4fb-e649-e053-2a91aa0acfc52023-01-23Exact identifier
unii: ETJ7Z6XBU4
Gyno ComplexVIBURNUM OPULUS, MAGNESIA PHOSPHORICA, FOLLICULINUM, PULSATILLA (PRATENSIS), BORAX, MERCURIUS SOLUBILIS, NITRICUM ACIDUM, SILICEA, THUJA OCCIDENTALISDeseret Biologicals, Incdfaaa56a-4226-4f62-a219-d3f89fe7afe32023-01-12WarningsExact identifier
unii: ETJ7Z6XBU4
SiliceaSILICON DIOXIDEBoiron86d367e5-e846-54ba-e053-2991aa0a63d42023-01-12Exact identifier
unii: ETJ7Z6XBU4
Perfect SleepADENOSINUM TRIPHOSPHORICUM DINATRUM, PANTOTHENIC ACID, UBIDECARENONUM, PINEAL GLAND (SUIS), SARCOLACTICUM ACIDUM, MELATONIN, PYRROLE, TRYPTOPHAN, ARSENICUM ALBUM, AVENA SATIVA, CHAMOMILLA, COFFEA CRUDA, MERCURIUS CORROSIVUS, PASSIFLORA INCARNATA, SILICEA, ZINCUM VALERIANICUM, DYSENTERY BACILLUS, GAERTNER BACILLUSDeseret Biologicals, Inc.f267fff4-f331-49b8-bd48-7d383da522462023-01-11WarningsExact identifier
unii: ETJ7Z6XBU4
DALEKTRO NSILVER NITRATE, OYSTER SHELL CALCIUM CARBONATE, CRUDE, COBALTOUS NITRATE HEXAHYDRATE, CUPRIC ACETATE, IRON, POTASSIUM CARBONATE, MAGNESIUM CHLORIDE, MANGANESE ACETATE TETRAHYDRATE, SELENIUM, SILICON DIOXIDE, AND ZINC PHOSPHIDEPEKANA Natruheilmittel GmbH2b39ce30-54ff-4586-bda1-d9410140b26e2023-01-11WarningsExact identifier
unii: ETJ7Z6XBU4
RehydrateAVENA SATIVA, EQUISETUM HYEMALE, HYPERICUM PERFORATUM, ULMUS FULVA, GLYCYRRHIZA GLABRA, SILICEA, PUERARIA LOBATA, CARLSBAD AQUA, ADENOSINUM TRIPHOSPHORICUM DINATRUM, GERMANIUM SESQUIOXIDE, HYDROGEN, OXYGEN, WIESBADENParaDocs All Natural, Inc.648fab10-c46b-420f-a42c-6642009d83fb2023-01-10WarningsExact identifier
unii: ETJ7Z6XBU4
SUPRENARSENIC TRIOXIDE, SULFURIC ACID, CHAMAELIRIUM LUTEUM ROOT, GOLDENSEAL, WOOD CREOSOTE, LEMNA MINOR, MAGNESIUM FLUORIDE, AND SILICON DIOXIDEPEKANA Naturheilmittel GmbH3b34740c-b181-4f05-9858-15b7211a4c672022-12-22WarningsExact identifier
unii: ETJ7Z6XBU4
KELANSILICON DIOXIDE, ARNICA MONTANA ROOT, GRAPHITE, HYPERICUM PERFORATUM, LEDUM PALUSTRE TWIG, MAGNESIUM FLUORIDE, MAGNESIUM SULFATE HEPTAHYDRATE, AND RUTA GRAVEOLENS FLOWERING TOPPEKANA Naturheilmittel GmbH55786d99-ee1f-490f-9023-3e6c39da86b02022-12-22WarningsExact identifier
unii: ETJ7Z6XBU4
COLIC CPAETHUSA CYNAPIUM, ALUMINUM OXIDE, BRYONIA ALBA ROOT, OYSTER SHELL CALCIUM CARBONATE CRUDE, MATRICARIA RECUTITA, LYCOPODIUM CLAVATUM SPORE, PHOSPHORUS, ANEMONE PULSATILLA, SILICON DIOXIDE, SULFUR.Natural Creations, Inc.7c2a2f6e-a332-4c68-a7a8-fdc390f1827e2022-12-19WarningsExact identifier
unii: ETJ7Z6XBU4
WartsANTIMON. CRUD., BRYONIA, CALC.CARB., CAUSTICUM, DULCAMARA, GRAPHITES, LYCOPODIUM, MERC. SULPH. RUB., NAT. CARB., NITRICUM AC., NUX VOM., RHUS TOXICODENDRON, SABINA, SEPIA, SILICEA, STAPHYSAG., SULPHUR, THUJA OCC., TARAXACUMNewton Laboratories, Inc.f0315c9e-8922-c0b5-e053-2a95a90ae54e2022-12-19WarningsExact identifier
unii: ETJ7Z6XBU4
WartsANTIMON. CRUD., BRYONIA, CALC.CARB., CAUSTICUM, DULCAMARA, GRAPHITES, LYCOPODIUM, MERC. SULPH. RUB., NAT. CARB., NITRICUM AC., NUX VOM., RHUS TOXICODENDRON, SABINA, SEPIA, SILICEA, STAPHYSAG., SULPHUR, THUJA OCC., TARAXACUMNewton Laboratories, Inc.f031e256-fca5-3939-e053-2995a90a4fe62022-12-19WarningsExact identifier
unii: ETJ7Z6XBU4
SILICEASILICON DIOXIDEHyland's Inc.86da31ff-b39a-4ac2-92e5-810f6d8888e62022-12-19WarningsExact identifier
unii: ETJ7Z6XBU4
WartsANTIMON. CRUD., BRYONIA, CALC.CARB., CAUSTICUM, DULCAMARA, GRAPHITES, LYCOPODIUM, MERC. SULPH. RUB., NAT. CARB., NITRICUM AC., NUX VOM., RHUS TOXICODENDRON, SABINA, SEPIA, SILICEA, STAPHYSAG., SULPHUR, THUJA OCC., TARAXACUMNewton Laboratories, Inc.f0328097-e5d2-3532-e053-2a95a90a93f02022-12-19WarningsExact identifier
unii: ETJ7Z6XBU4
WartsANTIMON. CRUD., BRYONIA, CALC.CARB., CAUSTICUM, DULCAMARA, GRAPHITES, LYCOPODIUM, MERC. SULPH. RUB., NAT. CARB., NITRICUM AC., NUX VOM., RHUS TOXICODENDRON, SABINA, SEPIA, SILICEA, STAPHYSAG., SULPHUR, THUJA OCC., TARAXACUMNewton Laboratories, Inc.f032e7bb-a6fd-2951-e053-2a95a90a8c3a2022-12-19WarningsExact identifier
unii: ETJ7Z6XBU4
CataraccARSENICUM ALB., BRYONIA, CALC. FLUOR., CALENDULA, CAUSTICUM, CONIUM, EUPHRASIA, HYDROFLUORICUM AC., IODIUM, LEDUM, NAPHTHALINUM, NAT. MUR., NUX VOM., PHOS., PULSATILLA, SEPIA, SILICEA, TELLURIUM, THIOSINAMINUM, ZINC. MET.Newton Laboratories, Inc.eff981fd-5436-7c34-e053-2a95a90a3e8e2022-12-16WarningsExact identifier
unii: ETJ7Z6XBU4
SiliceaSILICON DIOXIDEHyland's Inc.d3c426ab-1a61-3494-e053-2a95a90a96772022-12-14WarningsExact identifier
unii: ETJ7Z6XBU4
SiliceaSILICEAHahnemann Laboratories, INC.efcdc393-5dab-38d1-e053-2995a90acb2e2022-12-14Exact identifier
unii: ETJ7Z6XBU4

Reported adverse events (FAERS/openFDA)#

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