Niferex

Product NDC
75854-321
Requested package NDC
75854-321-30
11-digit product format
758540321
Labeler code
75854
Product ID
75854-321_b8552673-ba5c-3d80-e053-2995a90a1fa5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ferrous asparto glycinate, iron, ascorbic acid, folic acid, cyanocobalamin, zinc, succinic acid, and intrinsic factor
Dosage form
TABLET
Route
ORAL
Labeler
Avion Pharmaceuticals, LLC
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2017-01-10
Marketing end
0000-00-00
Substance
FERROUS ASPARTO GLYCINATE; IRON DEXTRAN; ASCORBIC ACID; LEVOMEFOLIC ACID; FOLIC ACID; CYANOCOBALAMIN; ZINC; SUCCINIC ACID; INTRINSIC FACTOR
Active strength
50 mg/1; mg/1; mg/1; ug/1; ug/1; ug/1; mg/1; mg/1; mg/1
Pharmacologic classes
Iron [CS],Parenteral Iron Replacement [EPC],Phosphate Binder [EPC],Phosphate Chelating Activity [MoA],Vitamin C [EPC],Ascorbic Acid [CS],Vitamin B 12 [CS],Vitamin B12 [EPC]
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage75854-32175854-321-30DDiscontinued by firm2026-10-05

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 · 9 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…

Reported adverse events (FAERS/openFDA)#

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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
75854-321-30EA - Each75854-321b89367e9-18d6-45a5-aa77-e3fbf11eba1412017-03-06

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
75854-321-307585403213030 TABLET in 1 BOTTLE (75854-321-30) 30 tablet2017-01-100000-00-00NoNoCurrent