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 62 of 74 · 1,467 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DV HPCALCAREA CARBONICA, CHENOPODIUM ANTHELMINTICUM, COCCULUS INDICUS, CONIUM MACULATUM, NUX VOMICA, PHOSPHORUS, PULSATILLA (VULGARIS), SILICEABioActive Nutritional, Inc.74bda12d-5e3d-4f52-9e3f-98012c92fc912024-01-05WarningsExact identifier
unii: ETJ7Z6XBU4
Childrens Mylicon All in One Tummy Relief for KidsANTACID AND ANTIGASInfirst Healthcare Inc.0952eba8-6de2-4a77-956d-339fab4374722024-01-01WarningsExact identifier
unii: H0G9379FGK
Mylanta Coat and CoolCALCIUM CARBONATE, MAGNESIUM HYDROXIDE, SIMETHICONEINFIRST HEALTHCARE INC.b6571f7f-e1ea-4034-a46c-4de1d01beec32024-01-01WarningsExact identifier
unii: H0G9379FGK
LymphdrainexGERANIUM ROBERTIANUM, NASTURTIUM AQUATICUM, TEUCRIUM SCORODONIA, EQUISETUM HYEMALE, FUMARIA OFFICINALIS, NATRUM SULPHURICUM, PHYTOLACCA DECANDRA, PINUS SYLVESTRIS, VERONICA OFFICINALIS, BAPTISIA TINCTORIA, GALIUM APARINE, GENTIANA LUTEA, APIS MELLIFICA, SARSAPARILLA (SMILAX REGELII), BARYTA CARBONICA, HEPAR SULPHURIS CALCAREUM, MERCURIUS CYANATUS, SCROPHULARIA NODOSA, ALOE, FERRUM IODATUM, MYOSOTIS ARVENSIS, ARANEA DIADEMA, CALCAREA PHOSPHORICA, JUGLANS REGIA, PARATHYROID GLAND (BOVINE), SILICEA,Energique, Inc.22c8f143-1c23-4a10-9577-2adc03f1b6b22023-12-28WarningsExact identifier
unii: ETJ7Z6XBU4
Folic AcidFOLIC ACIDModavar Pharmaceuticals LLC0eea15e4-7e5d-44e9-818b-a0bdf5271c782023-12-25Warnings, Adverse reactionsExact identifier
unii: 935E97BOY8
Folic AcidFOLIC ACIDCadila Pharmaceuticals Limited103c2cdd-5822-48ba-b62a-e2b11aa444ef2023-12-23Warnings, Adverse reactionsExact identifier
unii: 935E97BOY8
MenatrolFOLATE, MULTIVITAMINPureTek Corporation0a100e7d-3a8d-2d8b-e063-6394a90a32032023-12-18Boxed warning, Adverse reactionsExact identifier
unii: H0G9379FGK
unii: 68Y4CF58BV
Calcium CarbonateCALCIUM CARBONATEHumco Holding Group, Inc.8b207b49-d3fd-4108-b611-dca27c9dc78a2023-12-15WarningsExact identifier
unii: H0G9379FGK
Mylanta One Antacid/Anti-GasCALCIUM CARBONATE, MAGNESIUM HYDROXIDE, DIMETHICONEInfirst Healthcare Inc.aa694e0d-7891-4870-8106-dd57f1e29fb42023-12-11WarningsExact identifier
unii: H0G9379FGK
Mylanta One Antacid/Anti-GasCALCIUM CARBONATE, MAGNESIUM HYDROXIDE, DIMETHICONEInfirst Healthcare Inc.ed1b03f0-fabc-4c1c-8e6d-9f15c380300c2023-12-11WarningsExact identifier
unii: H0G9379FGK
GoodSense Regular Strength AntacidCALCIUM CARBONATEGoodSense53de9018-fbe4-425a-85f6-ebf08d1087302023-12-07WarningsExact identifier
unii: H0G9379FGK
Guardian Extra Strength Assorted Berry Antacid Extra strength Assorted Berry AntacidCALCIUM CARBONATEGuardian Drug Company1abd8d4a-c91f-4ead-8cfb-4237c16d723f2023-12-05WarningsExact identifier
unii: H0G9379FGK
FOLIC ACIDFOLIC ACIDBryant Ranch Prepack0b263a1e-260b-4775-a76e-766add336f122023-12-04Warnings, Adverse reactionsExact identifier
unii: 935E97BOY8
Doxylamine Succinate and Pyridoxine HydrochlorideDOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE, DELAYED RELEASE TABLETS 10 MG/10 MGBryant Ranch Prepackc283720d-f9a5-471f-9616-853a70f2b31d2023-12-04Warnings, Adverse reactionsExact identifier
unii: 68Y4CF58BV
Childrens Mylicon Tummy Relief for KidsANTACID AND ANTIGASInfirst Healthcare Inc.432d5b4c-a69b-45f9-b7f0-216726a3eead2023-12-01WarningsExact identifier
unii: H0G9379FGK
CyanocobalaminCYANOCOBALAMINHikma Pharmaceuticals USA Inc.a66eb3c4-3e1d-4d49-b963-4fa2334cc9b62023-12-01Warnings, Adverse reactionsExact identifier
unii: P6YC3EG204
Davimet-MMULTIVITAMINPureTek Corporation0b67e8de-d81e-0fda-e063-6394a90ac2292023-11-30Warnings, Adverse reactionsExact identifier
unii: 68Y4CF58BV
Guardian Regular Strength AlkumsCALCIUM CARBONATEGuardian Drug Companyd7df3e77-2f9a-4f81-864e-7647b1ccb57d2023-11-22WarningsExact identifier
unii: H0G9379FGK
Cellular OxygenatorCACTUS GRANDIFLORUS, ASCORBICUM ACIDUM, NICOTINAMIDUM, PYRIDOXINUM HYDROCHLORICUM, THIAMINUM HYDROCHLORICUM, MAGNESIUM GLUCONICUM DIHYDRICUM, RIBOFLAVINUM, MAGNESIA PHOSPHORICA, ADENOSINUM TRIPHOSPHORICUM DINATRUM, ALPHA-LIPOICUM ACIDUM, ANTHRACHINONUM, COENZYME A, NADIDUM, NAJA TRIPUDIANS, UBIDECARENONUM (COQ10)Nutritional Specialties, Inc.e5869f25-276f-456a-ab05-2a1899845afb2023-11-21WarningsExact identifier
unii: 68Y4CF58BV
TerrestristatALFALFA, AVENA SATIVA, FUCUS VESICULOSUS, ARALIA QUINQUEFOLIA, NATRUM CARBONICUM, THYROIDINUM (SUIS), CEREBRUM SUIS, PINEAL GLAND (SUIS), RHODODENDRON CHRYSANTHUM, AGATE, ARGENTUM NITRICUM, CADMIUM IODATUM, CALCAREA PHOSPHORICA, COFFEA CRUDA, CUPRUM METALLICUM, MERCURIUS CORROSIVUS, PHOSPHORICUM ACIDUM, PHOSPHORUS, QUARTZ, SILICEA, STRONTIUM CARBONICUM, RADIUM BROMATUM, CARCINOSIN, TARENTULA CUBENSIS, X-RAY, HOLMIUM METALLICUM, URANIUM NITRICUM.Energique, Inc.9bd83312-6872-4e39-b7ff-bbeb69015d802023-11-17WarningsExact identifier
unii: ETJ7Z6XBU4

Reported adverse events (FAERS/openFDA)#

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