FDA.reportPublic FDA data

Niferex

Product NDC
75854-344
11-digit product format
758540344
Labeler code
75854
Product ID
75854-344_7eb0b406-c408-4c8e-aab2-495564b1a2ef
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ferrous asparto glycinate, iron, ascorbic acid, folic acid, cyanocobalamin, zinc, and succinic acid
Dosage form
TABLET
Route
ORAL
Labeler
Avion Pharmaceuticals, LLC
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2024-12-16
Substance
FERROUS ASPARTO GLYCINATE; ASCORBIC ACID; LEVOMEFOLATE GLUCOSAMINE; FOLIC ACID; CYANOCOBALAMIN; ZINC; SUCCINIC ACID
Active strength
75; 175; 750; 250; 25; 15; 150 mg/1; mg/1; ug/1; ug/1; ug/1; mg/1; mg/1
Pharmacologic classes
Ascorbic Acid [CS], Vitamin B 12 [CS], Vitamin B12 [EPC], Vitamin C [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product
Yes
Brand name base
Niferex
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FERROUS ASPARTO GLYCINATE75 mg/1
ASCORBIC ACID175 mg/1
LEVOMEFOLATE GLUCOSAMINE750 ug/1
FOLIC ACID250 ug/1
CYANOCOBALAMIN25 ug/1
ZINC15 mg/1
SUCCINIC ACID150 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 7 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
H7426RGB3LInternal UNII lookup
PQ6CK8PD0RInternal UNII lookup
Q65PL71Q1AInternal UNII lookup
935E97BOY8Internal UNII lookup
P6YC3EG204Internal UNII lookup
J41CSQ7QDSInternal UNII lookup
AB6MNQ6J6LInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
a38ff367-983b-42db-ae5e-c9f75f7ace13Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
b82b4008-22fd-05f5-6cc6-c0a6e81c65b8Product name220240805
91c62db0-0295-c81c-d10a-0856c259edd6Product name220200428
d32bc2b8-0bb7-2216-87aa-24639646e202Product name320190619
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122
d206bb34-ea65-399d-70d9-834f22dc2c18Product name320170724

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
75854-344-30Niferex30 in 1 BOTTLETABLET307

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
75854-344-30EA - Each75854-3441cd71ba2-e488-439a-af37-55abb0e79b7e12025-01-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
75854-344NIFEREX (FERROUS ASPARTO GLYCINATE, IRON, ASCORBIC ACID, FOLIC ACID, CYANOCOBALAMIN, ZINC, AND SUCCINIC ACID) TABLET [AVION PHARMACEUTICALS, LLC]7Current NDC, 1 package rows20250410_a38ff367-983b-42db-ae5e-c9f75f7ace13.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
NiferexFERROUS ASPARTO GLYCINATE, IRON, ASCORBIC ACID, FOLIC ACID, CYANOCOBALAMIN, ZINC, AND SUCCINIC ACIDAvion Pharmaceuticals, LLCa38ff367-983b-42db-ae5e-c9f75f7ace132025-04-08Boxed warning, Adverse reactionsExact identifier
ndc (product): 75854-344

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
75854-344-307585403443030 TABLET in 1 BOTTLE (75854-344-30) 30 tablet2024-12-16NoNoCurrent