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 54 of 74 · 1,467 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
HypothalmuparARALIA QUINQUEFOLIA, GINKGO BILOBA, HYDROCOTYLE ASIATICA, CEREBRUM SUIS, HYPOPHYSIS SUIS, HYPOTHALAMUS SUIS, PHOSPHORUS, SILICEAEnergique, Inc.8b01e718-83b7-4f93-8fea-d0e37c7561852024-10-28WarningsExact identifier
unii: ETJ7Z6XBU4
Premier Value Chewable Antacid Extra Strength Tropical FruitANTACID TABLETSChain Drug Consortium8999b9c1-05d0-496b-88f2-062908a4fadc2024-10-25WarningsExact identifier
unii: H0G9379FGK
Premier Value Chewable Antacid Extra Strength Assorted FruitANTACID TABLETSChain Drug Consortiumef8ab31b-d050-446a-bca9-4a94d4ba17522024-10-25WarningsExact identifier
unii: H0G9379FGK
Premier Value Extra Strength Freshmint FlavorCALCIUM CARBONATE ,MAGNESIUM HYDROXIDECHAIN DRUG CONSORTIUM, LLC1192ebeb-f6cc-45db-8f07-12d36eb55a5f2024-10-25WarningsExact identifier
unii: H0G9379FGK
Premier Value Maximum Strength Assorted FruitCALCIUM CARBONATE, SIMETHICONEPHARMACY VALUE ALLIANCE, LLCe25bf9ca-415b-4a3e-a502-59074308da542024-10-25WarningsExact identifier
unii: H0G9379FGK
PV Extra Strength AntacidCALCIUM CARBONATEPHARMACY VALUE ALLIANCE, LLC8c92de83-ed60-46c3-b289-4b45a1915e242024-10-25WarningsExact identifier
unii: H0G9379FGK
Premier Value Chewable Antacid Ultra Strength Assorted FruitANTACID TABLETSChain Drug Consortium26c742a7-5806-44e0-bef0-c70a9d77dd232024-10-25WarningsExact identifier
unii: H0G9379FGK
Premier Value Chewable Antacid Assorted FruitANTACID TABLETSChain Drug Consortium, LLC00a58373-77ab-4a46-9862-d179e17c731a2024-10-25WarningsExact identifier
unii: H0G9379FGK
Premier Value Multi Symptom Antacid Berry FlavorCALCIUM CARBONATE ,MAGNESIUM HYDROXIDE,SIMETHICONEPharmacy Value Alliance LLC69e0c4a8-04ae-461b-bf47-4180bccd91d62024-10-25WarningsExact identifier
unii: H0G9379FGK
Premier Value Regular Strength Chewable Antacid Peppermint Assorted FruitANTACID TABLETSChain Drug Consortium, LLC245e195f-fd67-497b-83d4-fef75cea8b5b2024-10-25WarningsExact identifier
unii: H0G9379FGK
Folic AcidFOLIC ACIDAmneal Pharmaceuticals LLCc8fe09f0-b32b-43e3-8de7-ed38593b33b42024-10-25Warnings, Adverse reactionsExact identifier
unii: 935E97BOY8
FATIGUE NOSODE EBASTRAGALUS MEMBRANACEUS, ECHINACEA (ANGUSTIFOLIA), PHYTOLACCA DECANDRA, HYDRASTIS CANADENSIS, ARANEA DIADEMA, IRIDIUM METALLICUM, LYCOPODIUM CLAVATUM, RHUS TOX, SILICEA, SEPIA, EPSTEIN-BARR VIRUS NOSODEEnergique, Inc.36d963cc-fd47-40ee-aa73-c2e7fcedf1922024-10-24WarningsExact identifier
unii: ETJ7Z6XBU4
Complexion HPCARBO ANIMALIS, CARBO VEGETABILIS, KALI BICHROMICUM, KALI IODATUM, NATRUM MURIATICUM, PULSATILLA (PRATENSIS), SEPIA, SILICEA, SULPHUR, ZINCUM METALLICUMEnergique, Inc.ad12d51e-04cb-4833-b802-0038796966ff2024-10-24WarningsExact identifier
unii: ETJ7Z6XBU4
OHTAS ISAN ANTACIDCALCIUM CARBONATE, SODIUM BICARBONATEOHTA'S ISAN CO.,LTD.53380470-5748-6fa7-548e-7484ef204c0f2024-10-21WarningsExact identifier
unii: H0G9379FGK
OHTAS ISAN ANTACIDCALCIUM CARBONATE, SODIUM BICARBONATEOHTA'S ISAN CO.,LTD.8723fe90-8402-4511-b6c6-b71cf98513e32024-10-21WarningsExact identifier
unii: H0G9379FGK
Folic AcidFOLIC ACIDBryant Ranch Prepackfd0ec9f8-f547-4e5a-9847-a7ddfc3344bc2024-10-15Warnings, Adverse reactionsExact identifier
unii: 935E97BOY8
Pyridoxine HydrochloridePYRIDOXINE HYDROCHLORIDEFresenius Kabi USA, LLCa56d11c0-b033-4201-85ff-fc710506481a2024-10-15Warnings, Adverse reactionsExact identifier
unii: 68Y4CF58BV
Citrus Flavored AntacidCALCIUM CARBONATEJHK DBA American Safety & First Aid79f2b495-a438-408e-9572-b6c3516db52c2024-10-15WarningsExact identifier
unii: H0G9379FGK
Folic AcidFOLIC ACIDFresenius Kabi USA, LLCe215318c-4f8b-4711-ae76-f370d1da0f3b2024-10-14Warnings, Adverse reactionsExact identifier
unii: 935E97BOY8
NUTRALOXCALCIUM CARBONATEA-S Medication Solutions524e26a9-c69f-4e25-b83d-f4c65adca83d2024-10-11WarningsExact identifier
unii: H0G9379FGK

Reported adverse events (FAERS/openFDA)#

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