Home NDC 67457-957 Iron Sucrose
Product NDC 67457-957
11-digit product format 674570957
Labeler code 67457
Product ID 67457-957_3f109bdb-a412-43b2-84c7-9dad05e85a71
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Iron Sucrose
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler Mylan Institutional LLC
Application ANDA212559
Marketing category ANDA
Marketing start 2025-08-11
Substance IRON SUCROSE
Active strength 50 mg/2.5mL
Pharmacologic classes Iron [CS], Parenteral Iron Replacement [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A212559-001 IRON SUCROSE IRON SUCROSE EQ 50MG IRON/2.5ML (EQ 20MG IRON/ML) INJECTABLE / INTRAVENOUS AB 2025-08-08 A212559-002 IRON SUCROSE IRON SUCROSE EQ 100MG IRON/5ML (EQ 20MG IRON/ML) INJECTABLE / INTRAVENOUS AB 2025-08-08 A212559-003 IRON SUCROSE IRON SUCROSE EQ 200MG IRON/10ML (EQ 20MG IRON/ML) INJECTABLE / INTRAVENOUS AB 2025-08-08
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 matching rows.
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 2 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration A212559-002 CGT 2026-02-07 A212559-003 CGT 2026-02-07
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 2026-08-18 06:07:40 2026-07 A212559-001 IRON SUCROSE EQ 50MG IRON/2.5ML (EQ 20MG IRON/ML) INJECTABLE / INTRAVENOUS AB 2025-08-08 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A212559-002 IRON SUCROSE EQ 100MG IRON/5ML (EQ 20MG IRON/ML) INJECTABLE / INTRAVENOUS AB 2025-08-08 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A212559-003 IRON SUCROSE EQ 200MG IRON/10ML (EQ 20MG IRON/ML) INJECTABLE / INTRAVENOUS AB 2025-08-08 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A212559-001 IRON SUCROSE EQ 50MG IRON/2.5ML (EQ 20MG IRON/ML) INJECTABLE / INTRAVENOUS AB 2025-08-08 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A212559-002 IRON SUCROSE EQ 100MG IRON/5ML (EQ 20MG IRON/ML) INJECTABLE / INTRAVENOUS AB 2025-08-08 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A212559-003 IRON SUCROSE EQ 200MG IRON/10ML (EQ 20MG IRON/ML) INJECTABLE / INTRAVENOUS AB 2025-08-08 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A212559-001 IRON SUCROSE EQ 50MG IRON/2.5ML (EQ 20MG IRON/ML) INJECTABLE / INTRAVENOUS AB 2025-08-08 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A212559-002 IRON SUCROSE EQ 100MG IRON/5ML (EQ 20MG IRON/ML) INJECTABLE / INTRAVENOUS AB 2025-08-08 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A212559-003 IRON SUCROSE EQ 200MG IRON/10ML (EQ 20MG IRON/ML) INJECTABLE / INTRAVENOUS AB 2025-08-08 31067a03dcf5…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A212559-001 IRON SUCROSE EQ 50MG IRON/2.5ML (EQ 20MG IRON/ML) INJECTABLE / INTRAVENOUS AB 2025-08-08 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A212559-002 IRON SUCROSE EQ 100MG IRON/5ML (EQ 20MG IRON/ML) INJECTABLE / INTRAVENOUS AB 2025-08-08 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A212559-003 IRON SUCROSE EQ 200MG IRON/10ML (EQ 20MG IRON/ML) INJECTABLE / INTRAVENOUS AB 2025-08-08 a50c72e98297…
Observed Orange Book normalized TE history# Observed Orange Book exclusivity history# Captured, Edition, Application-product table Captured Edition Application-product Exclusivity code Expiration Source SHA-256 2026-08-18 06:07:40 2026-07 A212559-002 CGT 2026-02-07 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A212559-003 CGT 2026-02-07 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A212559-002 CGT 2026-02-07 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A212559-003 CGT 2026-02-07 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A212559-002 CGT 2026-02-07 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A212559-003 CGT 2026-02-07 31067a03dcf5…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A212559-002 CGT 2026-02-07 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A212559-003 CGT 2026-02-07 a50c72e98297…
Additional Listing Data#
Finished product Yes
Brand name base Iron Sucrose
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength IRON SUCROSE 50 mg/2.5mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination FZ7NYF5N8L Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1741261 Internal RxNorm lookup 1741267 Internal RxNorm lookup 1741270 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 67457-957-00 Iron Sucrose 1 in 1 CARTON INJECTION, SOLUTION 1 1 67457-957-00 Iron Sucrose 2.5 mL in 1 VIAL, SINGLE-DOSE INJECTION, SOLUTION 2.5 1 67457-957-25 Iron Sucrose 2.5 mL in 1 VIAL, SINGLE-DOSE INJECTION, SOLUTION 2.5 1 67457-957-25 Iron Sucrose 25 in 1 CARTON INJECTION, SOLUTION 25 1 67457-957-99 Iron Sucrose 10 in 1 CARTON INJECTION, SOLUTION 10 1 67457-957-99 Iron Sucrose 2.5 mL in 1 VIAL, SINGLE-DOSE INJECTION, SOLUTION 2.5 1
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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 67457-957-00 67457095700 1 in 1 CARTON Historical 67457-957-25 67457095725 2.5 mL in 1 VIAL, SINGLE-DOSE 2.5 ml Historical 67457-957-99 67457095799 10 VIAL, SINGLE-DOSE in 1 CARTON (67457-957-99) / 2.5 mL in 1 VIAL, SINGLE-DOSE 2025-08-11 No No Current