FDA.reportPublic FDA data

NDC 75834-080 - Niva-Fol

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
75834-080
Package NDCs from labels
75834-080-90
Manufacturer
Nivagen Pharmaceuticals, Inc. | Natural Vitamins Laboratory Corp
Effective date
2021-09-16
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Niva-Fol - Nivagen Pharmaceuticals, Inc. | Natural Vitamins Laboratory CorpNivagen Pharmaceuticals, Inc. | Natural Vitamins Laboratory Corp2021-09-16DIETARY SUPPLEMENT

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
75834-080-90Niva-Fol90 in 1 BOTTLETABLET904

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
75834-080NIVA-FOL (PYRIDOXINE, FOLIC ACID, AND CYANOCOBALAMIN) TABLET [NIVAGEN PHARMACEUTICALS, INC.]41 package rows20210918_acd020d4-8dcf-403d-a8b4-06fb6e67d8b5.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
75834-080-90EA - Each75834-080a38fc0a1-be87-46e8-9c01-cc5c4574ba3912016-01-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CyanocobalaminACTIVE INGREDIENTP6YC3EG204NIVA-FOL (PYRIDOXINE, FOLIC ACID, AND CYANOCOBALAMIN) TABLET [NIVAGEN PHARMACEUTICALS, INC.]2
Folic AcidACTIVE INGREDIENT935E97BOY8NIVA-FOL (PYRIDOXINE, FOLIC ACID, AND CYANOCOBALAMIN) TABLET [NIVAGEN PHARMACEUTICALS, INC.]2
Pyridoxine HydrochlorideACTIVE INGREDIENT68Y4CF58BVNIVA-FOL (PYRIDOXINE, FOLIC ACID, AND CYANOCOBALAMIN) TABLET [NIVAGEN PHARMACEUTICALS, INC.]2
CYANOCOBALAMINACTIVE MOIETYP6YC3EG204NIVA-FOL (PYRIDOXINE, FOLIC ACID, AND CYANOCOBALAMIN) TABLET [NIVAGEN PHARMACEUTICALS, INC.]2
FOLIC ACIDACTIVE MOIETY935E97BOY8NIVA-FOL (PYRIDOXINE, FOLIC ACID, AND CYANOCOBALAMIN) TABLET [NIVAGEN PHARMACEUTICALS, INC.]2
PYRIDOXINEACTIVE MOIETYKV2JZ1BI6ZNIVA-FOL (PYRIDOXINE, FOLIC ACID, AND CYANOCOBALAMIN) TABLET [NIVAGEN PHARMACEUTICALS, INC.]2
Calcium CarbonateINACTIVE INGREDIENTH0G9379FGKNIVA-FOL (PYRIDOXINE, FOLIC ACID, AND CYANOCOBALAMIN) TABLET [NIVAGEN PHARMACEUTICALS, INC.]2
Croscarmellose SodiumINACTIVE INGREDIENTM28OL1HH48NIVA-FOL (PYRIDOXINE, FOLIC ACID, AND CYANOCOBALAMIN) TABLET [NIVAGEN PHARMACEUTICALS, INC.]2
Magnesium StearateINACTIVE INGREDIENT70097M6I30NIVA-FOL (PYRIDOXINE, FOLIC ACID, AND CYANOCOBALAMIN) TABLET [NIVAGEN PHARMACEUTICALS, INC.]2
ShellacINACTIVE INGREDIENT46N107B71ONIVA-FOL (PYRIDOXINE, FOLIC ACID, AND CYANOCOBALAMIN) TABLET [NIVAGEN PHARMACEUTICALS, INC.]2
Silicon DioxideINACTIVE INGREDIENTETJ7Z6XBU4NIVA-FOL (PYRIDOXINE, FOLIC ACID, AND CYANOCOBALAMIN) TABLET [NIVAGEN PHARMACEUTICALS, INC.]2
Stearic AcidINACTIVE INGREDIENT4ELV7Z65APNIVA-FOL (PYRIDOXINE, FOLIC ACID, AND CYANOCOBALAMIN) TABLET [NIVAGEN PHARMACEUTICALS, INC.]2

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 50 of 74 · 1,467 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
HEB Extra Strength Smooth Antacid Assorted FruitsCALCIUM CARBONATEH E B2faac316-7b59-4df8-b751-37069e8652632024-12-26WarningsExact identifier
unii: H0G9379FGK
Good Neighbor Pharmacy Antacid Extra StrengthCALCIUM CARBONATEAmerisourceBergen Drug Corporation5e3a3c20-dabe-4427-9e75-99759905caa02024-12-26WarningsExact identifier
unii: H0G9379FGK
HEB Extra Strength Smooth Antacid PeppermintCALCIUM CARBONATEH E Bd04e691e-6d1c-4c39-9504-7ac0f1bd197d2024-12-26WarningsExact identifier
unii: H0G9379FGK
AntacidCALCIUM CARBONATETrifecta Pharmaceuticals USA LLC14a7916e-5363-7f1b-e063-6294a90a20aa2024-12-20WarningsExact identifier
unii: H0G9379FGK
CyanocobalaminCYANOCOBALAMINVitruvias Therapeutics2117af8a-723f-4e2f-98a6-83ad2c4237512024-12-20Warnings, Adverse reactionsExact identifier
unii: P6YC3EG204
GOODSENSE Ultra Strength Antacid PeppermintCALCIUM CARBONATEGoodSense04950b56-7760-4b6c-8110-86b6a3f795b42024-12-19WarningsExact identifier
unii: H0G9379FGK
Goodsense Regular Strength Antacid PeppermintCALCIUM CARBONATEGoodSense32c04f3e-59f3-44aa-ad92-6724449827102024-12-19WarningsExact identifier
unii: H0G9379FGK
Trace Mineral CordARGENTUM METALLICUM, AURUM METALLICUM, BORON CITRATE, CALCAREA FLUORICA, CALCAREA PHOSPHORICA, CALCAREA SULPHURICA, CHROMIUM SULPHURICUM, COBALT GLUCONATE, CUPRUM SULPHURICUM, FERRUM PHOSPHORICUM, GERMANIUM SESQUIOXIDE, IODIUM, KALI BROMATUM, KALI MURIATICUM, KALI PHOSPHORICUM, KALI SULPHURICUM, LITHIUM CARBONICUM, MAGNESIA PHOSPHORICA, MANGANUM MURIATICUM, NATRUM MURIATICUM, NATRUM PHOSPHORICUM, NATRUM SULPHURICUM, SELENIUM METALLICUM, SILICEA, SODIUM MOLYBDATE, STRONTIUM CARBONICUM, VANADIUM METALLICUM,Energique, Inc.902dd68d-5ce1-481e-8938-6487dcc68dfc2024-12-19WarningsExact identifier
unii: ETJ7Z6XBU4
GOODSENSE Ultra Strength Antacid Assorted FruitCALCIUM CARBONATEGoodSensead4d51f6-b55b-45db-b034-fb3da54fbe992024-12-19WarningsExact identifier
unii: H0G9379FGK
TUMS Extra Strength Sugar-FreeCALCIUM CARBONATEHaleon US Holdings LLC3495102f-55d2-4a94-8d55-f46f49e00c272024-12-19WarningsExact identifier
unii: H0G9379FGK
Goodsense Extra Strength Antacid Assorted FruitCALCIUM CARBONATEGoodSenseae6270fc-0f8d-4bba-8f12-adba3f07f7c52024-12-19WarningsExact identifier
unii: H0G9379FGK
Quality Choice Extra Strength Assorted Berry Antacid Extra strength Assorted Berry AntacidCALCIUM CARBONATEChain Drug Marketing Association Inc.ec729051-72d3-4d1a-8e39-d4495d5c1cf32024-12-18WarningsExact identifier
unii: H0G9379FGK
Guardian Extra Strength AntacidCALCIUM CARBONATEGuardian Drug Companyaef3d830-c5c3-4f72-86ba-d31945a756db2024-12-18WarningsExact identifier
unii: H0G9379FGK
Tums Chewy BitesCALCIUM CARBONATENavajo Manufacturing Company Inc.297d6703-ed4e-10d3-e063-6394a90a9f3a2024-12-17WarningsExact identifier
unii: H0G9379FGK
Calcium Carbonate 10 gr (648 mg) (Antacid)CALCIUM CARBONATE 10GR (648 MG)RUGBY LABORATORIESf21c8cf7-45cb-492b-bf4a-462024a545692024-12-17WarningsExact identifier
unii: H0G9379FGK
Extra Strength Antacid Tablets, Caseys 4goodCALCIUM CARBONATE 750 MGLil' Drug Store Prodsucts, Inc.026aefd6-bb80-1ffd-e063-6394a90a12622024-12-16WarningsExact identifier
unii: H0G9379FGK
CyanocobalaminCYANOCOBALAMINFresenius Kabi USA, LLCacff4ff3-4435-4995-a117-dbfcdf72334a2024-12-15Warnings, Adverse reactionsExact identifier
unii: P6YC3EG204
Foster and Thrive Regular Strength AntacidCALCIUM CARBONATEStrategic Sourcing Services LLC1aeb60fb-eebe-4e54-be1c-4e01f3b7269c2024-12-13WarningsExact identifier
unii: H0G9379FGK
Foster and Thrive Extra Strength Antacid 127AF Extra Strength Antacid Assorted FruitCALCIUM CARBONATEStrategic Sourcing Services LLC8b2fabf7-4dc6-445a-842c-b28ae081fdc82024-12-13WarningsExact identifier
unii: H0G9379FGK
CyanocobalaminCYANOCOBALAMINFresenius Kabi USA, LLC8b1cdee5-3368-40e4-90bf-31a64df1f38a2024-12-12Warnings, Adverse reactionsExact identifier
unii: P6YC3EG204

Reported adverse events (FAERS/openFDA)#

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