Home NDC 72078-060 Ferric Carboxymaltose
Product NDC 72078-060
11-digit product format 720780060
Labeler code 72078
Product ID 72078-060_37214620-8bd3-4a01-a07c-bedf5cd6ae0a
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Ferric Carboxymaltose
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler Mylan Institutional LLC
Application ANDA217769
Marketing category ANDA
Marketing start 2026-07-01
Substance FERRIC CARBOXYMALTOSE
Active strength 50 mg/mL
Pharmacologic classes Iron [CS], Parenteral Iron Replacement [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A217769-001 FERRIC CARBOXYMALTOSE FERRIC CARBOXYMALTOSE 100MG IRON/2ML (50MG IRON/ML) SOLUTION / INTRAVENOUS AP 2026-06-25
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A217769-001 AP
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-09-14 22:38:34 2026-08 A217769-001 FERRIC CARBOXYMALTOSE 100MG IRON/2ML (50MG IRON/ML) SOLUTION / INTRAVENOUS AP 2026-06-25 84e616aacf4f…2026-08-18 06:07:40 2026-07 A217769-001 FERRIC CARBOXYMALTOSE 100MG IRON/2ML (50MG IRON/ML) SOLUTION / INTRAVENOUS AP 2026-06-25 caaa826d4ba7…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A217769-001 FERRIC CARBOXYMALTOSE 100MG IRON/2ML (50MG IRON/ML) SOLUTION / INTRAVENOUS AP 2026-06-25 a50c72e98297…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-09-14 22:38:34 2026-08 A217769-001 AP 1 84e616aacf4f…2026-08-18 06:07:40 2026-07 A217769-001 AP 1 caaa826d4ba7…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A217769-001 AP 1 a50c72e98297…
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 Ferric Carboxymaltose
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength FERRIC CARBOXYMALTOSE 50 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 6897GXD6OE Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2602296 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 72078-060-99 72078006099 1 VIAL, SINGLE-DOSE in 1 CARTON (72078-060-99) / 2 mL in 1 VIAL, SINGLE-DOSE (72078-060-00) 2026-07-01 No No Current