FDA.reportPublic FDA data

NDC 72078-060-00 - Ferric Carboxymaltose

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
72078-060
Requested NDC
72078-060-00
Package NDCs from labels
72078-060-00, 72078-060-99
Manufacturer
Mylan Institutional LLC
Effective date
2026-09-16
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Ferric Carboxymaltose - Mylan Institutional LLCMylan Institutional LLC2026-09-16HUMAN PRESCRIPTION DRUG LABEL

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 10 · 198 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Ferric CarboxymaltoseFERRIC CARBOXYMALTOSE INJECTIONSandoz, Inc.bfdf7447-62e4-48ca-b903-11cb3b2110642026-09-02Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 6897GXD6OE
KUGIG ALOE FOAMING INTIMATE WASHINTIMATE CLEANSING FOAMHong Kong KangXing Centennial Management Limited59f4d398-1186-a168-e063-6294a90ab44b2026-08-26WarningsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERREMEDYREPACK INC.5dd5d148-6e23-41de-bff5-551b2aea95982026-08-24Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
InjectaferFERRIC CARBOXYMALTOSE INJECTIONAmerican Regent, Inc.517b4a19-45b3-4286-9f6a-ced4e10447de2026-08-19Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 2602296
unii: 6897GXD6OE
Ferric CarboxymaltoseFERRIC CARBOXYMALTOSEMylan Institutional LLC7f05ab1e-aed4-4f87-b939-2dc9719aa34c2026-08-15Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 6897GXD6OE
Ferric CarboxymaltoseFERRIC CARBOXYMALTOSEMylan Institutional LLC8e8e95f4-8d3a-4658-9f6c-09edf22103412026-08-15Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA217769
ndc (package): 72078-060-00
ndc (package): 72078-060-99
ndc (product): 72078-060
ndc11 (package): 72078006000
rxcui: 2602296
spl id: 37214620-8bd3-4a01-a07c-bedf5cd6ae0a
spl set id: 8e8e95f4-8d3a-4658-9f6c-09edf2210341
unii: 6897GXD6OE
Ferric CarboxymaltoseFERRIC CARBOXYMALTOSEMylan Institutional LLCd6a5cd2d-86bd-4042-974f-46e14d65fc2d2026-08-15Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 6897GXD6OE
BM BM63 DROPSCEANOTHUS, KALI ARSEN, KALI MUR, SELENIUM, THALLIUM, WIESBADENBM Private Limited59006d82-610a-2e08-e063-6394a90af1ed2026-08-14WarningsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERCardinal Health 107, LLC48d75a7c-8329-48a8-bea0-a8c144ddf6372026-08-07Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
GarzulysINSULIN ASPART-FSANMeitheal Pharmaceuticals Inc.30c64769-d2f7-4604-ac9e-2a6bc09506c92026-07-31Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
DECONIMO ReconstitutionDECONIMO RECONSTITUTIONImage Amazon LLC57ab9b1c-9a18-3786-e063-6394a90a2c632026-07-28WarningsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERCardinal Health 107, LLC9655cd02-82b5-4a75-813b-854b195514812026-07-21Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Dr. Drop NMN Vital Balance (Drop No.1 Cream 90g)NMN (NICOTINAMIDE MONONUCLEOTIDE), ECTOIN (ECTOINE)Reedfresh Co., LTD55d703ca-ff9d-0dbc-e063-6294a90ab6b12026-07-05WarningsExact identifier
unii: 059QF0KO0R
Eyesaline Eyewash ConcentratePURIFIED WATERProtective Industrial Products, Inc.558e5926-9027-d3f6-e063-6294a90ab1212026-07-02WarningsExact identifier
unii: 059QF0KO0R
Fendall 2000 Pure FlowPURIFIED WATERProtective Industrial Products, Inc.55a1d07e-0006-0c75-e063-6394a90a7acc2026-07-02WarningsExact identifier
unii: 059QF0KO0R
Fendall 1000 Pure FlowPURIFIED WATERProtective Industrial Products, Inc.55a2f4da-bb1e-8ead-e063-6394a90af72e2026-07-02WarningsExact identifier
unii: 059QF0KO0R
Sterile Eyesaline EyewashSTERILE EYESALINE EYEWASHProtective Industrial Products, Inc.55a290e8-8310-8be4-e063-6394a90abdce2026-07-02WarningsExact identifier
unii: 059QF0KO0R
Eyesaline Emergency EyewashPURIFIED WATERProtective Industrial Products, Inc.55a261c2-725d-6765-e063-6294a90a32602026-07-02WarningsExact identifier
unii: 059QF0KO0R
RemodulinTREPROSTINILUnited Therapeutics Corporation6c80bb38-e8db-4138-9f0d-dbbf9c6731852026-07-02Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Fendall 2000 Pure FlowPURIFIED WATERHoneywell Safety Products USA, Inc.37dead3e-60cb-88ae-e063-6294a90a8f702026-06-24WarningsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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