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

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 2 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2019-12-08 06:16 UTC · source 2019-12-05excluded productproduct59088-112IInactivated by FDAexcluded / ndc_excluded.zip110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage59088-11259088-112-66IInactivated by FDAexcluded / ndc_excluded.zip110d247fa046…a55b01930146…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CUPRIC SULFATE10 mg/1
FERROUS FUMARATE.8 mg/1
IRON DEXTRAN15 ug/1
RIBOFLAVIN53 mg/1
NIACINAMIDE1 mg/1
PYRIDOXINE HYDROCHLORIDE53 mg/1
FOLIC ACID1.3 mg/1
CYANOCOBALAMIN30 mg/1
CALCIUM PANTOTHENATE5 mg/1
SODIUM ASCORBATE6 mg/1
THIAMINE MONONITRATE200 mg/1
ZINC SULFATE10 mg/1
MANGANESE SULFATE18.2 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 13 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
LRX7AJ16DTInternal UNII lookup
R5L488RY0QInternal UNII lookup
95HR524N2MInternal UNII lookup
TLM2976OFRInternal UNII lookup
25X51I8RD4Internal UNII lookup
68Y4CF58BVInternal UNII lookup
935E97BOY8Internal UNII lookup
P6YC3EG204Internal UNII lookup
568ET80C3DInternal UNII lookup
S033EH8359Internal UNII lookup
8K0I04919XInternal UNII lookup
89DS0H96TBInternal UNII lookup
W00LYS4T26Internal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
71f63741-cad4-43b5-bb3e-c63a188d10a2Available on FDA.report

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

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
PureVit DualFe PlusFERROUS FUMARATE, POLYSACCHARIDE IRON COMPLEXPureTek Corporation71f63741-cad4-43b5-bb3e-c63a188d10a22023-01-11Warnings, Adverse reactionsExact identifier
ndc (product): 59088-112

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