PureVit DualFe Plus

Product NDC
59088-112
11-digit product format
590880112
Labeler code
59088
Product ID
59088-112_f2048b24-433b-98ba-e053-2995a90a5e85
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ferrous Fumarate, Polysaccharide Iron Complex
Dosage form
CAPSULE
Route
ORAL
Labeler
PureTek Corporation
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2011-06-01
Substance
CALCIUM PANTOTHENATE; CUPRIC SULFATE; CYANOCOBALAMIN; FERROUS FUMARATE; FOLIC ACID; IRON DEXTRAN; MANGANESE SULFATE; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN; SODIUM ASCORBATE; THIAMINE MONONITRATE; ZINC SULFATE
Active strength
10; .8; 15; 53; 1; 53; 1.3; 30; 5; 6; 200; 10; 18.2 mg/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1
Pharmacologic classes
Analogs/Derivatives [Chemical/Ingredient], Ascorbic Acid [CS], Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE], Iron [CS], Magnetic Resonance Contrast Activity [MoA], Paramagnetic Contrast Agent [EPC], Parenteral Iron Replacement [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Vitamin B 12 [CS], Vitamin B 6 [Chemical/Ingredient], Vitamin B12 [EPC], Vitamin B6 Analog [EPC], Vitamin C [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
PureVit DualFe Plus
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CALCIUM PANTOTHENATE10 mg/1
CUPRIC SULFATE.8 mg/1
CYANOCOBALAMIN15 ug/1
FERROUS FUMARATE53 mg/1
FOLIC ACID1 mg/1
IRON DEXTRAN53 mg/1
MANGANESE SULFATE1.3 mg/1
NIACINAMIDE30 mg/1
PYRIDOXINE HYDROCHLORIDE5 mg/1
RIBOFLAVIN6 mg/1
SODIUM ASCORBATE200 mg/1
THIAMINE MONONITRATE10 mg/1
ZINC SULFATE18.2 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii568ET80C3D, LRX7AJ16DT, P6YC3EG204, R5L488RY0Q, 935E97BOY8, 95HR524N2M, W00LYS4T26, 25X51I8RD4, 68Y4CF58BV, TLM2976OFR, S033EH8359, 8K0I04919X, 89DS0H96TB

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f47a510b-6679-4664-b2d6-47b5c4afe7ccProduct name420260217
cf050ccd-1144-f76a-e00d-e5698d8597d4Product name620250625
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515
59361619-24d9-b610-eca6-5a7f25ed5e03Product name520240909
b82b4008-22fd-05f5-6cc6-c0a6e81c65b8Product name220240805
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
04cdd491-d111-4bc2-9549-75c575e1bd4bProduct name120200714
8390fb8b-6c75-416c-a9a1-70e8ed493b73Product name120200611
91c62db0-0295-c81c-d10a-0856c259edd6Product name220200428
96a528e9-23e2-495f-81b9-ae87df2f7552Product name120191120
d32bc2b8-0bb7-2216-87aa-24639646e202Product name320190619
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122
d206bb34-ea65-399d-70d9-834f22dc2c18Product name320170724
5e18e798-5614-cf5c-0185-38b1cb77a093Product name220160822
3df56c93-5837-4523-aac2-4b1ec48b9676Product name220160719
a883b7cc-d320-41d7-92ae-c873457ae641Product name120151116
bb23e78e-9e64-4037-a1c1-0e1d8762700eProduct name120150325
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508
ef06c001-572c-d95e-42f6-ee83da75673aProduct name120140508
fd21f957-6863-d07b-5a35-250186878716Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
59088-112-662020-03-18C16284748780-197431aae-1634-960c-e053-dbdaa90a7534PureVit DualFe Plus
59088-112-662019-11-13C16284748780-197431aae-1634-960c-e053-dbdaa90a7534PureVit DualFe Plus

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59088-112-66PureVit DualFe Plus90 in 1 BOTTLE, PLASTICCAPSULE903

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59088-112-66EA - Each59088-1127e05dc4b-dbf6-423f-8164-6c1208eeadc512012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CALCIUM PANTOTHENATEACTIVE INGREDIENT568ET80C3DPUREVIT DUALFE PLUS (FERROUS FUMARATE, POLYSACCHARIDE IRON COMPLEX) CAPSULE [PURETEK CORPORATION]1
CUPRIC SULFATEACTIVE INGREDIENTLRX7AJ16DTPUREVIT DUALFE PLUS (FERROUS FUMARATE, POLYSACCHARIDE IRON COMPLEX) CAPSULE [PURETEK CORPORATION]1
CYANOCOBALAMINACTIVE INGREDIENTP6YC3EG204PUREVIT DUALFE PLUS (FERROUS FUMARATE, POLYSACCHARIDE IRON COMPLEX) CAPSULE [PURETEK CORPORATION]1
FERROUS FUMARATEACTIVE INGREDIENTR5L488RY0QPUREVIT DUALFE PLUS (FERROUS FUMARATE, POLYSACCHARIDE IRON COMPLEX) CAPSULE [PURETEK CORPORATION]1
FOLIC ACIDACTIVE INGREDIENT935E97BOY8PUREVIT DUALFE PLUS (FERROUS FUMARATE, POLYSACCHARIDE IRON COMPLEX) CAPSULE [PURETEK CORPORATION]1
IRON DEXTRANACTIVE INGREDIENT95HR524N2MPUREVIT DUALFE PLUS (FERROUS FUMARATE, POLYSACCHARIDE IRON COMPLEX) CAPSULE [PURETEK CORPORATION]1
MANGANESE SULFATEACTIVE INGREDIENTW00LYS4T26PUREVIT DUALFE PLUS (FERROUS FUMARATE, POLYSACCHARIDE IRON COMPLEX) CAPSULE [PURETEK CORPORATION]1
NIACINAMIDEACTIVE INGREDIENT25X51I8RD4PUREVIT DUALFE PLUS (FERROUS FUMARATE, POLYSACCHARIDE IRON COMPLEX) CAPSULE [PURETEK CORPORATION]1
PYRIDOXINE HYDROCHLORIDEACTIVE INGREDIENT68Y4CF58BVPUREVIT DUALFE PLUS (FERROUS FUMARATE, POLYSACCHARIDE IRON COMPLEX) CAPSULE [PURETEK CORPORATION]1
RIBOFLAVINACTIVE INGREDIENTTLM2976OFRPUREVIT DUALFE PLUS (FERROUS FUMARATE, POLYSACCHARIDE IRON COMPLEX) CAPSULE [PURETEK CORPORATION]1
SODIUM ASCORBATEACTIVE INGREDIENTS033EH8359PUREVIT DUALFE PLUS (FERROUS FUMARATE, POLYSACCHARIDE IRON COMPLEX) CAPSULE [PURETEK CORPORATION]1
THIAMINE MONONITRATEACTIVE INGREDIENT8K0I04919XPUREVIT DUALFE PLUS (FERROUS FUMARATE, POLYSACCHARIDE IRON COMPLEX) CAPSULE [PURETEK CORPORATION]1
ZINC SULFATEACTIVE INGREDIENT89DS0H96TBPUREVIT DUALFE PLUS (FERROUS FUMARATE, POLYSACCHARIDE IRON COMPLEX) CAPSULE [PURETEK CORPORATION]1
ASCORBIC ACIDACTIVE MOIETYPQ6CK8PD0RPUREVIT DUALFE PLUS (FERROUS FUMARATE, POLYSACCHARIDE IRON COMPLEX) CAPSULE [PURETEK CORPORATION]1
COPPERACTIVE MOIETY789U1901C5PUREVIT DUALFE PLUS (FERROUS FUMARATE, POLYSACCHARIDE IRON COMPLEX) CAPSULE [PURETEK CORPORATION]1
CYANOCOBALAMINACTIVE MOIETYP6YC3EG204PUREVIT DUALFE PLUS (FERROUS FUMARATE, POLYSACCHARIDE IRON COMPLEX) CAPSULE [PURETEK CORPORATION]1
FOLIC ACIDACTIVE MOIETY935E97BOY8PUREVIT DUALFE PLUS (FERROUS FUMARATE, POLYSACCHARIDE IRON COMPLEX) CAPSULE [PURETEK CORPORATION]1
IRONACTIVE MOIETYE1UOL152H7PUREVIT DUALFE PLUS (FERROUS FUMARATE, POLYSACCHARIDE IRON COMPLEX) CAPSULE [PURETEK CORPORATION]1
MANGANESEACTIVE MOIETY42Z2K6ZL8PPUREVIT DUALFE PLUS (FERROUS FUMARATE, POLYSACCHARIDE IRON COMPLEX) CAPSULE [PURETEK CORPORATION]1
NIACINACTIVE MOIETY2679MF687APUREVIT DUALFE PLUS (FERROUS FUMARATE, POLYSACCHARIDE IRON COMPLEX) CAPSULE [PURETEK CORPORATION]1
PANTOTHENIC ACIDACTIVE MOIETY19F5HK2737PUREVIT DUALFE PLUS (FERROUS FUMARATE, POLYSACCHARIDE IRON COMPLEX) CAPSULE [PURETEK CORPORATION]1
PYRIDOXINEACTIVE MOIETYKV2JZ1BI6ZPUREVIT DUALFE PLUS (FERROUS FUMARATE, POLYSACCHARIDE IRON COMPLEX) CAPSULE [PURETEK CORPORATION]1
RIBOFLAVINACTIVE MOIETYTLM2976OFRPUREVIT DUALFE PLUS (FERROUS FUMARATE, POLYSACCHARIDE IRON COMPLEX) CAPSULE [PURETEK CORPORATION]1
THIAMINEACTIVE MOIETYX66NSO3N35PUREVIT DUALFE PLUS (FERROUS FUMARATE, POLYSACCHARIDE IRON COMPLEX) CAPSULE [PURETEK CORPORATION]1
ZINC CATIONACTIVE MOIETY13S1S8SF37PUREVIT DUALFE PLUS (FERROUS FUMARATE, POLYSACCHARIDE IRON COMPLEX) CAPSULE [PURETEK CORPORATION]1
FD&C YELLOW NO. 5INACTIVE INGREDIENTI753WB2F1MPUREVIT DUALFE PLUS (FERROUS FUMARATE, POLYSACCHARIDE IRON COMPLEX) CAPSULE [PURETEK CORPORATION]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8PUREVIT DUALFE PLUS (FERROUS FUMARATE, POLYSACCHARIDE IRON COMPLEX) CAPSULE [PURETEK CORPORATION]1
GELATININACTIVE INGREDIENT2G86QN327LPUREVIT DUALFE PLUS (FERROUS FUMARATE, POLYSACCHARIDE IRON COMPLEX) CAPSULE [PURETEK CORPORATION]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PUREVIT DUALFE PLUS (FERROUS FUMARATE, POLYSACCHARIDE IRON COMPLEX) CAPSULE [PURETEK CORPORATION]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4PUREVIT DUALFE PLUS (FERROUS FUMARATE, POLYSACCHARIDE IRON COMPLEX) CAPSULE [PURETEK CORPORATION]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPPUREVIT DUALFE PLUS (FERROUS FUMARATE, POLYSACCHARIDE IRON COMPLEX) CAPSULE [PURETEK CORPORATION]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59088-112PUREVIT DUALFE PLUS (FERROUS FUMARATE, POLYSACCHARIDE IRON COMPLEX) CAPSULE [PURETEK CORPORATION]3Current NDC, Legacy NDC, 1 package rows20230112_71f63741-cad4-43b5-bb3e-c63a188d10a2.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59088-112-665908801126690 CAPSULE in 1 BOTTLE, PLASTIC (59088-112-66) 90 capsule2011-06-010000-00-00NoNoCurrent