Home NDC 72078-060 Ferric Carboxymaltose
Product NDC 72078-060
11-digit product format 720780060
Labeler code 72078
Product ID 72078-060_1c70f595-9a34-4b6a-bbbb-cdb36ef8ec14
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 44 .
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 2026-10-15 13:18:30 2026-09 A217769-001 FERRIC CARBOXYMALTOSE 100MG IRON/2ML (50MG IRON/ML) SOLUTION / INTRAVENOUS AP 2026-06-25 c2088c7a36db…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# 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
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