Dialyvite 5000

Product NDC
10542-011
11-digit product format
105420011
Labeler code
10542
Product ID
10542-011_a9664d9c-5fde-4ef0-ba5a-378744acfbf2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ascorbic Acid, Tocopheryl Acid Succinate, Thiamine, Riboflavin, Niacinamide, Pyridoxine, Folic Acid, Cobalamin, Biotin, Pantothenic Acid, Zinc, Selenium
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Hillestad Pharmaceuticals USA
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2008-05-01
Marketing end
2027-02-28
Substance
.ALPHA.-TOCOPHEROL SUCCINATE, D-; ASCORBIC ACID; BIOTIN; CALCIUM PANTOTHENATE; COBALAMIN; FOLIC ACID; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN; SELENOCYSTEINE; THIAMINE MONONITRATE; ZINC CITRATE
Active strength
30; 100; 300; 10; 2; 5; 20; 50; 1.7; 70; 1.5; 25 [iU]/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1; mg/1; mg/1
Pharmacologic classes
Analogs/Derivatives [Chemical/Ingredient], Ascorbic Acid [CS], Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE], 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 5000

Active Ingredients#

Ingredient, Strength table
IngredientStrength
.ALPHA.-TOCOPHEROL SUCCINATE, D-30 [iU]/1
ASCORBIC ACID100 mg/1
BIOTIN300 ug/1
CALCIUM PANTOTHENATE10 mg/1
COBALAMIN2 mg/1
FOLIC ACID5 mg/1
NIACINAMIDE20 mg/1
PYRIDOXINE HYDROCHLORIDE50 mg/1
RIBOFLAVIN1.7 mg/1
SELENOCYSTEINE70 ug/1
THIAMINE MONONITRATE1.5 mg/1
ZINC CITRATE25 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiLU4B53JYVE, PQ6CK8PD0R, 6SO6U10H04, 568ET80C3D, 8406EY2OQA, 935E97BOY8, 25X51I8RD4, 68Y4CF58BV, TLM2976OFR, 0CH9049VIS, 8K0I04919X, K72I3DEX9B

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f47a510b-6679-4664-b2d6-47b5c4afe7ccProduct name420260217
86fffa7b-d382-4771-a253-25cccb64b590Product name320251124
cf050ccd-1144-f76a-e00d-e5698d8597d4Product name620250625
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515
59361619-24d9-b610-eca6-5a7f25ed5e03Product name520240909
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
91c62db0-0295-c81c-d10a-0856c259edd6Product name220200428
d32bc2b8-0bb7-2216-87aa-24639646e202Product name320190619
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122
5e18e798-5614-cf5c-0185-38b1cb77a093Product name220160822
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10542-011-02Dialyvite 50007 in 1 BOTTLE, PLASTICTABLET, COATED75
10542-011-09Dialyvite 500090 in 1 BOTTLE, PLASTICTABLET, COATED905

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
10542-011-09EA - Each10542-0114f9dda64-cd62-4eaa-a17d-41862684b34912014-10-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
.alpha.-tocopherol succinate, d-ACTIVE INGREDIENTLU4B53JYVEDIALYVITE 5000 (ASCORBIC ACID, TOCOPHERYL ACID SUCCINATE, THIAMINE, RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE, FOLIC ACID, COBALAMIN, BIOTIN, PANTOTHENIC ACID, ZINC, SELENIUM) TABLET, COATED [HILLESTAD PHARMACEUTICALS USA]1
Ascorbic AcidACTIVE INGREDIENTPQ6CK8PD0RDIALYVITE 5000 (ASCORBIC ACID, TOCOPHERYL ACID SUCCINATE, THIAMINE, RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE, FOLIC ACID, COBALAMIN, BIOTIN, PANTOTHENIC ACID, ZINC, SELENIUM) TABLET, COATED [HILLESTAD PHARMACEUTICALS USA]1
BiotinACTIVE INGREDIENT6SO6U10H04DIALYVITE 5000 (ASCORBIC ACID, TOCOPHERYL ACID SUCCINATE, THIAMINE, RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE, FOLIC ACID, COBALAMIN, BIOTIN, PANTOTHENIC ACID, ZINC, SELENIUM) TABLET, COATED [HILLESTAD PHARMACEUTICALS USA]1
Calcium PantothenateACTIVE INGREDIENT568ET80C3DDIALYVITE 5000 (ASCORBIC ACID, TOCOPHERYL ACID SUCCINATE, THIAMINE, RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE, FOLIC ACID, COBALAMIN, BIOTIN, PANTOTHENIC ACID, ZINC, SELENIUM) TABLET, COATED [HILLESTAD PHARMACEUTICALS USA]1
CobalaminACTIVE INGREDIENT8406EY2OQADIALYVITE 5000 (ASCORBIC ACID, TOCOPHERYL ACID SUCCINATE, THIAMINE, RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE, FOLIC ACID, COBALAMIN, BIOTIN, PANTOTHENIC ACID, ZINC, SELENIUM) TABLET, COATED [HILLESTAD PHARMACEUTICALS USA]1
Folic AcidACTIVE INGREDIENT935E97BOY8DIALYVITE 5000 (ASCORBIC ACID, TOCOPHERYL ACID SUCCINATE, THIAMINE, RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE, FOLIC ACID, COBALAMIN, BIOTIN, PANTOTHENIC ACID, ZINC, SELENIUM) TABLET, COATED [HILLESTAD PHARMACEUTICALS USA]1
NiacinamideACTIVE INGREDIENT25X51I8RD4DIALYVITE 5000 (ASCORBIC ACID, TOCOPHERYL ACID SUCCINATE, THIAMINE, RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE, FOLIC ACID, COBALAMIN, BIOTIN, PANTOTHENIC ACID, ZINC, SELENIUM) TABLET, COATED [HILLESTAD PHARMACEUTICALS USA]1
Pyridoxine HydrochlorideACTIVE INGREDIENT68Y4CF58BVDIALYVITE 5000 (ASCORBIC ACID, TOCOPHERYL ACID SUCCINATE, THIAMINE, RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE, FOLIC ACID, COBALAMIN, BIOTIN, PANTOTHENIC ACID, ZINC, SELENIUM) TABLET, COATED [HILLESTAD PHARMACEUTICALS USA]1
RiboflavinACTIVE INGREDIENTTLM2976OFRDIALYVITE 5000 (ASCORBIC ACID, TOCOPHERYL ACID SUCCINATE, THIAMINE, RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE, FOLIC ACID, COBALAMIN, BIOTIN, PANTOTHENIC ACID, ZINC, SELENIUM) TABLET, COATED [HILLESTAD PHARMACEUTICALS USA]1
SelenocysteineACTIVE INGREDIENT0CH9049VISDIALYVITE 5000 (ASCORBIC ACID, TOCOPHERYL ACID SUCCINATE, THIAMINE, RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE, FOLIC ACID, COBALAMIN, BIOTIN, PANTOTHENIC ACID, ZINC, SELENIUM) TABLET, COATED [HILLESTAD PHARMACEUTICALS USA]1
Thiamine MononitrateACTIVE INGREDIENT8K0I04919XDIALYVITE 5000 (ASCORBIC ACID, TOCOPHERYL ACID SUCCINATE, THIAMINE, RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE, FOLIC ACID, COBALAMIN, BIOTIN, PANTOTHENIC ACID, ZINC, SELENIUM) TABLET, COATED [HILLESTAD PHARMACEUTICALS USA]1
Zinc CitrateACTIVE INGREDIENTK72I3DEX9BDIALYVITE 5000 (ASCORBIC ACID, TOCOPHERYL ACID SUCCINATE, THIAMINE, RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE, FOLIC ACID, COBALAMIN, BIOTIN, PANTOTHENIC ACID, ZINC, SELENIUM) TABLET, COATED [HILLESTAD PHARMACEUTICALS USA]1
.alpha.-tocopherol, d-ACTIVE MOIETYN9PR3490H9DIALYVITE 5000 (ASCORBIC ACID, TOCOPHERYL ACID SUCCINATE, THIAMINE, RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE, FOLIC ACID, COBALAMIN, BIOTIN, PANTOTHENIC ACID, ZINC, SELENIUM) TABLET, COATED [HILLESTAD PHARMACEUTICALS USA]1
Ascorbic AcidACTIVE MOIETYPQ6CK8PD0RDIALYVITE 5000 (ASCORBIC ACID, TOCOPHERYL ACID SUCCINATE, THIAMINE, RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE, FOLIC ACID, COBALAMIN, BIOTIN, PANTOTHENIC ACID, ZINC, SELENIUM) TABLET, COATED [HILLESTAD PHARMACEUTICALS USA]1
BiotinACTIVE MOIETY6SO6U10H04DIALYVITE 5000 (ASCORBIC ACID, TOCOPHERYL ACID SUCCINATE, THIAMINE, RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE, FOLIC ACID, COBALAMIN, BIOTIN, PANTOTHENIC ACID, ZINC, SELENIUM) TABLET, COATED [HILLESTAD PHARMACEUTICALS USA]1
CobalaminACTIVE MOIETY8406EY2OQADIALYVITE 5000 (ASCORBIC ACID, TOCOPHERYL ACID SUCCINATE, THIAMINE, RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE, FOLIC ACID, COBALAMIN, BIOTIN, PANTOTHENIC ACID, ZINC, SELENIUM) TABLET, COATED [HILLESTAD PHARMACEUTICALS USA]1
Folic AcidACTIVE MOIETY935E97BOY8DIALYVITE 5000 (ASCORBIC ACID, TOCOPHERYL ACID SUCCINATE, THIAMINE, RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE, FOLIC ACID, COBALAMIN, BIOTIN, PANTOTHENIC ACID, ZINC, SELENIUM) TABLET, COATED [HILLESTAD PHARMACEUTICALS USA]1
NiacinamideACTIVE MOIETY25X51I8RD4DIALYVITE 5000 (ASCORBIC ACID, TOCOPHERYL ACID SUCCINATE, THIAMINE, RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE, FOLIC ACID, COBALAMIN, BIOTIN, PANTOTHENIC ACID, ZINC, SELENIUM) TABLET, COATED [HILLESTAD PHARMACEUTICALS USA]1
Pantothenic AcidACTIVE MOIETY19F5HK2737DIALYVITE 5000 (ASCORBIC ACID, TOCOPHERYL ACID SUCCINATE, THIAMINE, RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE, FOLIC ACID, COBALAMIN, BIOTIN, PANTOTHENIC ACID, ZINC, SELENIUM) TABLET, COATED [HILLESTAD PHARMACEUTICALS USA]1
PyridoxineACTIVE MOIETYKV2JZ1BI6ZDIALYVITE 5000 (ASCORBIC ACID, TOCOPHERYL ACID SUCCINATE, THIAMINE, RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE, FOLIC ACID, COBALAMIN, BIOTIN, PANTOTHENIC ACID, ZINC, SELENIUM) TABLET, COATED [HILLESTAD PHARMACEUTICALS USA]1
RiboflavinACTIVE MOIETYTLM2976OFRDIALYVITE 5000 (ASCORBIC ACID, TOCOPHERYL ACID SUCCINATE, THIAMINE, RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE, FOLIC ACID, COBALAMIN, BIOTIN, PANTOTHENIC ACID, ZINC, SELENIUM) TABLET, COATED [HILLESTAD PHARMACEUTICALS USA]1
SeleniumACTIVE MOIETYH6241UJ22BDIALYVITE 5000 (ASCORBIC ACID, TOCOPHERYL ACID SUCCINATE, THIAMINE, RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE, FOLIC ACID, COBALAMIN, BIOTIN, PANTOTHENIC ACID, ZINC, SELENIUM) TABLET, COATED [HILLESTAD PHARMACEUTICALS USA]1
Thiamine IonACTIVE MOIETY4ABT0J945JDIALYVITE 5000 (ASCORBIC ACID, TOCOPHERYL ACID SUCCINATE, THIAMINE, RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE, FOLIC ACID, COBALAMIN, BIOTIN, PANTOTHENIC ACID, ZINC, SELENIUM) TABLET, COATED [HILLESTAD PHARMACEUTICALS USA]1
Zinc CationACTIVE MOIETY13S1S8SF37DIALYVITE 5000 (ASCORBIC ACID, TOCOPHERYL ACID SUCCINATE, THIAMINE, RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE, FOLIC ACID, COBALAMIN, BIOTIN, PANTOTHENIC ACID, ZINC, SELENIUM) TABLET, COATED [HILLESTAD PHARMACEUTICALS USA]1
BlueberryINACTIVE INGREDIENT253RUG1X1ADIALYVITE 5000 (ASCORBIC ACID, TOCOPHERYL ACID SUCCINATE, THIAMINE, RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE, FOLIC ACID, COBALAMIN, BIOTIN, PANTOTHENIC ACID, ZINC, SELENIUM) TABLET, COATED [HILLESTAD PHARMACEUTICALS USA]1
Calcium StearateINACTIVE INGREDIENT776XM7047LDIALYVITE 5000 (ASCORBIC ACID, TOCOPHERYL ACID SUCCINATE, THIAMINE, RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE, FOLIC ACID, COBALAMIN, BIOTIN, PANTOTHENIC ACID, ZINC, SELENIUM) TABLET, COATED [HILLESTAD PHARMACEUTICALS USA]1
Cellulose, microcrystallineINACTIVE INGREDIENTOP1R32D61UDIALYVITE 5000 (ASCORBIC ACID, TOCOPHERYL ACID SUCCINATE, THIAMINE, RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE, FOLIC ACID, COBALAMIN, BIOTIN, PANTOTHENIC ACID, ZINC, SELENIUM) TABLET, COATED [HILLESTAD PHARMACEUTICALS USA]1
Croscarmellose SodiumINACTIVE INGREDIENTM28OL1HH48DIALYVITE 5000 (ASCORBIC ACID, TOCOPHERYL ACID SUCCINATE, THIAMINE, RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE, FOLIC ACID, COBALAMIN, BIOTIN, PANTOTHENIC ACID, ZINC, SELENIUM) TABLET, COATED [HILLESTAD PHARMACEUTICALS USA]1
Glyceryl MonostearateINACTIVE INGREDIENT230OU9XXE4DIALYVITE 5000 (ASCORBIC ACID, TOCOPHERYL ACID SUCCINATE, THIAMINE, RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE, FOLIC ACID, COBALAMIN, BIOTIN, PANTOTHENIC ACID, ZINC, SELENIUM) TABLET, COATED [HILLESTAD PHARMACEUTICALS USA]1
ShellacINACTIVE INGREDIENT46N107B71ODIALYVITE 5000 (ASCORBIC ACID, TOCOPHERYL ACID SUCCINATE, THIAMINE, RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE, FOLIC ACID, COBALAMIN, BIOTIN, PANTOTHENIC ACID, ZINC, SELENIUM) TABLET, COATED [HILLESTAD PHARMACEUTICALS USA]1
Silicon DioxideINACTIVE INGREDIENTETJ7Z6XBU4DIALYVITE 5000 (ASCORBIC ACID, TOCOPHERYL ACID SUCCINATE, THIAMINE, RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE, FOLIC ACID, COBALAMIN, BIOTIN, PANTOTHENIC ACID, ZINC, SELENIUM) TABLET, COATED [HILLESTAD PHARMACEUTICALS USA]1
Starch, CornINACTIVE INGREDIENTO8232NY3SJDIALYVITE 5000 (ASCORBIC ACID, TOCOPHERYL ACID SUCCINATE, THIAMINE, RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE, FOLIC ACID, COBALAMIN, BIOTIN, PANTOTHENIC ACID, ZINC, SELENIUM) TABLET, COATED [HILLESTAD PHARMACEUTICALS USA]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10542-011DIALYVITE 5000 (ASCORBIC ACID, TOCOPHERYL ACID SUCCINATE, THIAMINE, RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE, FOLIC ACID, COBALAMIN, BIOTIN, PANTOTHENIC ACID, ZINC, SELENIUM) TABLET, COATED [HILLESTAD PHARMACEUTICALS USA]4Current NDC, Legacy NDC, 2 package rows20221015_97791f73-e0c5-45a6-8aed-f456a5466eaf.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
10542-011-02105420011027 TABLET, COATED in 1 BOTTLE, PLASTIC (10542-011-02) 2008-05-012027-02-28YesNoCurrent
10542-011-091054200110990 TABLET, COATED in 1 BOTTLE, PLASTIC (10542-011-09) 2008-05-012027-02-28NoNoCurrent