Dialyvite

Product NDC
10542-010
11-digit product format
105420010
Labeler code
10542
Product ID
10542-010_c91498fd-0515-46a9-8a22-e423f554bd86
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ascorbic Acid, Thiamine, Riboflavin, Niacinamide, Pyridoxine, Folic Acid, Cobalamin, Biotin, Pantothenic Acid
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Hillestad Pharmaceuticals USA
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
1988-08-01
Marketing end
2027-01-31
Substance
ASCORBIC ACID; BIOTIN; CALCIUM PANTOTHENATE; COBALAMIN; FOLIC ACID; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN; THIAMINE MONONITRATE
Active strength
100; 300; 10; 6; 1; 20; 10; 1.7; 1.5 mg/1; ug/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1
Pharmacologic classes
Analogs/Derivatives [Chemical/Ingredient], Ascorbic Acid [CS], Vitamin B 6 [Chemical/Ingredient], Vitamin B6 Analog [EPC], Vitamin C [EPC]
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Dialyvite

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ASCORBIC ACID100 mg/1
THIAMINE MONONITRATE300 ug/1
RIBOFLAVIN10 mg/1
NIACINAMIDE6 ug/1
PYRIDOXINE HYDROCHLORIDE1 mg/1
FOLIC ACID20 mg/1
COBALAMIN10 mg/1
BIOTIN1.7 mg/1
CALCIUM PANTOTHENATE1.5 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 9 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
PQ6CK8PD0RInternal UNII lookup
8K0I04919XInternal UNII lookup
TLM2976OFRInternal UNII lookup
25X51I8RD4Internal UNII lookup
68Y4CF58BVInternal UNII lookup
935E97BOY8Internal UNII lookup
8406EY2OQAInternal UNII lookup
6SO6U10H04Internal UNII lookup
568ET80C3DInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
7a5e6dd6-5687-44bb-8964-841961c0e64aAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
cf050ccd-1144-f76a-e00d-e5698d8597d4Product name620250625
59361619-24d9-b610-eca6-5a7f25ed5e03Product name520240909
91c62db0-0295-c81c-d10a-0856c259edd6Product name220200428
d32bc2b8-0bb7-2216-87aa-24639646e202Product name320190619
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122
5e18e798-5614-cf5c-0185-38b1cb77a093Product name220160822

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10542-010-02Dialyvite7 in 1 BOTTLE, PLASTICTABLET, COATED75
10542-010-10Dialyvite100 in 1 BOTTLE, PLASTICTABLET, COATED1005

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
10542-010-10EA - Each10542-010fae8b716-ac92-4d7b-9751-82a9a81a1e6612014-10-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Ascorbic AcidACTIVE INGREDIENTPQ6CK8PD0RDIALYVITE (ASCORBIC ACID, THIAMINE, RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE, FOLIC ACID, COBALAMIN, BIOTIN, PANTOTHENIC ACID) TABLET, COATED [HILLESTAD PHARMACEUTICALS USA]1
BiotinACTIVE INGREDIENT6SO6U10H04DIALYVITE (ASCORBIC ACID, THIAMINE, RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE, FOLIC ACID, COBALAMIN, BIOTIN, PANTOTHENIC ACID) TABLET, COATED [HILLESTAD PHARMACEUTICALS USA]1
Calcium PantothenateACTIVE INGREDIENT568ET80C3DDIALYVITE (ASCORBIC ACID, THIAMINE, RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE, FOLIC ACID, COBALAMIN, BIOTIN, PANTOTHENIC ACID) TABLET, COATED [HILLESTAD PHARMACEUTICALS USA]1
CobalaminACTIVE INGREDIENT8406EY2OQADIALYVITE (ASCORBIC ACID, THIAMINE, RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE, FOLIC ACID, COBALAMIN, BIOTIN, PANTOTHENIC ACID) TABLET, COATED [HILLESTAD PHARMACEUTICALS USA]1
Folic AcidACTIVE INGREDIENT935E97BOY8DIALYVITE (ASCORBIC ACID, THIAMINE, RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE, FOLIC ACID, COBALAMIN, BIOTIN, PANTOTHENIC ACID) TABLET, COATED [HILLESTAD PHARMACEUTICALS USA]1
NiacinamideACTIVE INGREDIENT25X51I8RD4DIALYVITE (ASCORBIC ACID, THIAMINE, RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE, FOLIC ACID, COBALAMIN, BIOTIN, PANTOTHENIC ACID) TABLET, COATED [HILLESTAD PHARMACEUTICALS USA]1
Pyridoxine HydrochlorideACTIVE INGREDIENT68Y4CF58BVDIALYVITE (ASCORBIC ACID, THIAMINE, RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE, FOLIC ACID, COBALAMIN, BIOTIN, PANTOTHENIC ACID) TABLET, COATED [HILLESTAD PHARMACEUTICALS USA]1
RiboflavinACTIVE INGREDIENTTLM2976OFRDIALYVITE (ASCORBIC ACID, THIAMINE, RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE, FOLIC ACID, COBALAMIN, BIOTIN, PANTOTHENIC ACID) TABLET, COATED [HILLESTAD PHARMACEUTICALS USA]1
Thiamine MononitrateACTIVE INGREDIENT8K0I04919XDIALYVITE (ASCORBIC ACID, THIAMINE, RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE, FOLIC ACID, COBALAMIN, BIOTIN, PANTOTHENIC ACID) TABLET, COATED [HILLESTAD PHARMACEUTICALS USA]1
Ascorbic AcidACTIVE MOIETYPQ6CK8PD0RDIALYVITE (ASCORBIC ACID, THIAMINE, RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE, FOLIC ACID, COBALAMIN, BIOTIN, PANTOTHENIC ACID) TABLET, COATED [HILLESTAD PHARMACEUTICALS USA]1
BiotinACTIVE MOIETY6SO6U10H04DIALYVITE (ASCORBIC ACID, THIAMINE, RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE, FOLIC ACID, COBALAMIN, BIOTIN, PANTOTHENIC ACID) TABLET, COATED [HILLESTAD PHARMACEUTICALS USA]1
CobalaminACTIVE MOIETY8406EY2OQADIALYVITE (ASCORBIC ACID, THIAMINE, RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE, FOLIC ACID, COBALAMIN, BIOTIN, PANTOTHENIC ACID) TABLET, COATED [HILLESTAD PHARMACEUTICALS USA]1
Folic AcidACTIVE MOIETY935E97BOY8DIALYVITE (ASCORBIC ACID, THIAMINE, RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE, FOLIC ACID, COBALAMIN, BIOTIN, PANTOTHENIC ACID) TABLET, COATED [HILLESTAD PHARMACEUTICALS USA]1
NiacinamideACTIVE MOIETY25X51I8RD4DIALYVITE (ASCORBIC ACID, THIAMINE, RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE, FOLIC ACID, COBALAMIN, BIOTIN, PANTOTHENIC ACID) TABLET, COATED [HILLESTAD PHARMACEUTICALS USA]1
Pantothenic AcidACTIVE MOIETY19F5HK2737DIALYVITE (ASCORBIC ACID, THIAMINE, RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE, FOLIC ACID, COBALAMIN, BIOTIN, PANTOTHENIC ACID) TABLET, COATED [HILLESTAD PHARMACEUTICALS USA]1
PyridoxineACTIVE MOIETYKV2JZ1BI6ZDIALYVITE (ASCORBIC ACID, THIAMINE, RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE, FOLIC ACID, COBALAMIN, BIOTIN, PANTOTHENIC ACID) TABLET, COATED [HILLESTAD PHARMACEUTICALS USA]1
RiboflavinACTIVE MOIETYTLM2976OFRDIALYVITE (ASCORBIC ACID, THIAMINE, RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE, FOLIC ACID, COBALAMIN, BIOTIN, PANTOTHENIC ACID) TABLET, COATED [HILLESTAD PHARMACEUTICALS USA]1
Thiamine IonACTIVE MOIETY4ABT0J945JDIALYVITE (ASCORBIC ACID, THIAMINE, RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE, FOLIC ACID, COBALAMIN, BIOTIN, PANTOTHENIC ACID) TABLET, COATED [HILLESTAD PHARMACEUTICALS USA]1
Calcium StearateINACTIVE INGREDIENT776XM7047LDIALYVITE (ASCORBIC ACID, THIAMINE, RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE, FOLIC ACID, COBALAMIN, BIOTIN, PANTOTHENIC ACID) TABLET, COATED [HILLESTAD PHARMACEUTICALS USA]1
Cellulose, microcrystallineINACTIVE INGREDIENTOP1R32D61UDIALYVITE (ASCORBIC ACID, THIAMINE, RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE, FOLIC ACID, COBALAMIN, BIOTIN, PANTOTHENIC ACID) TABLET, COATED [HILLESTAD PHARMACEUTICALS USA]1
CochinealINACTIVE INGREDIENTTZ8Z31B35MDIALYVITE (ASCORBIC ACID, THIAMINE, RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE, FOLIC ACID, COBALAMIN, BIOTIN, PANTOTHENIC ACID) TABLET, COATED [HILLESTAD PHARMACEUTICALS USA]1
Croscarmellose SodiumINACTIVE INGREDIENTM28OL1HH48DIALYVITE (ASCORBIC ACID, THIAMINE, RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE, FOLIC ACID, COBALAMIN, BIOTIN, PANTOTHENIC ACID) TABLET, COATED [HILLESTAD PHARMACEUTICALS USA]1
Glyceryl MonostearateINACTIVE INGREDIENT230OU9XXE4DIALYVITE (ASCORBIC ACID, THIAMINE, RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE, FOLIC ACID, COBALAMIN, BIOTIN, PANTOTHENIC ACID) TABLET, COATED [HILLESTAD PHARMACEUTICALS USA]1
HypromellosesINACTIVE INGREDIENT3NXW29V3WODIALYVITE (ASCORBIC ACID, THIAMINE, RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE, FOLIC ACID, COBALAMIN, BIOTIN, PANTOTHENIC ACID) TABLET, COATED [HILLESTAD PHARMACEUTICALS USA]1
Polyethylene GlycolsINACTIVE INGREDIENT3WJQ0SDW1ADIALYVITE (ASCORBIC ACID, THIAMINE, RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE, FOLIC ACID, COBALAMIN, BIOTIN, PANTOTHENIC ACID) TABLET, COATED [HILLESTAD PHARMACEUTICALS USA]1
Starch, CornINACTIVE INGREDIENTO8232NY3SJDIALYVITE (ASCORBIC ACID, THIAMINE, RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE, FOLIC ACID, COBALAMIN, BIOTIN, PANTOTHENIC ACID) TABLET, COATED [HILLESTAD PHARMACEUTICALS USA]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10542-010DIALYVITE (ASCORBIC ACID, THIAMINE, RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE, FOLIC ACID, COBALAMIN, BIOTIN, PANTOTHENIC ACID) TABLET, COATED [HILLESTAD PHARMACEUTICALS USA]4Current NDC, Legacy NDC, 2 package rows20221015_7a5e6dd6-5687-44bb-8964-841961c0e64a.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 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DialyviteASCORBIC ACID, THIAMINE, RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE, FOLIC ACID, COBALAMIN, BIOTIN, PANTOTHENIC ACIDHillestad Pharmaceuticals USA7a5e6dd6-5687-44bb-8964-841961c0e64a2026-01-27Adverse reactionsExact identifier
ndc (product): 10542-010

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
10542-010-02105420010027 TABLET, COATED in 1 BOTTLE, PLASTIC (10542-010-02) 1988-08-012027-01-31YesNoCurrent
10542-010-1010542001010100 TABLET, COATED in 1 BOTTLE, PLASTIC (10542-010-10) 1988-08-012027-01-31NoNoCurrent