Home NDC 0781-3486 Iron Sucrose
Product NDC 0781-3486
11-digit product format 007813486
Labeler code 0781
Product ID 0781-3486_78c04f10-0489-4e45-8cb5-28a6789d1149
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Iron Sucrose
Dosage form INJECTION
Route INTRAVENOUS
Labeler Sandoz Inc
Application ANDA212340
Marketing category ANDA
Marketing start 2025-09-22
Substance IRON SUCROSE
Active strength 100 mg/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 A212340-001 IRON SUCROSE IRON SUCROSE EQ 50MG IRON/2.5ML (EQ 20MG IRON/ML) INJECTABLE / INTRAVENOUS AB 2025-08-08 A212340-002 IRON SUCROSE IRON SUCROSE EQ 100MG IRON/5ML (EQ 20MG IRON/ML) INJECTABLE / INTRAVENOUS AB 2025-08-08 A212340-003 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.
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 A212340-001 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 A212340-002 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 A212340-003 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 A212340-001 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 A212340-002 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 A212340-003 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 A212340-001 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 A212340-002 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 A212340-003 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 A212340-001 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 A212340-002 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 A212340-003 IRON SUCROSE EQ 200MG IRON/10ML (EQ 20MG IRON/ML) INJECTABLE / INTRAVENOUS AB 2025-08-08 a50c72e98297…
Observed Orange Book normalized TE history# 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 100 mg/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 0781-3486-75 Iron Sucrose 5 mL in 1 VIAL, SINGLE-DOSE INJECTION 5 1 0781-3486-95 Iron Sucrose 10 in 1 CARTON INJECTION 10 1 0781-3486-96 Iron Sucrose 25 in 1 CARTON INJECTION 25 1 0781-3486-96 Iron Sucrose 5 mL in 1 VIAL, SINGLE-DOSE INJECTION 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 0781-3486-75 00781348675 5 mL in 1 VIAL, SINGLE-DOSE 5 ml Historical 0781-3486-95 00781348695 10 VIAL, SINGLE-DOSE in 1 CARTON (0781-3486-95) / 5 mL in 1 VIAL, SINGLE-DOSE (0781-3486-75) 2025-09-22 No No Current 0781-3486-96 00781348696 25 VIAL, SINGLE-DOSE in 1 CARTON (0781-3486-96) / 5 mL in 1 VIAL, SINGLE-DOSE 2025-09-22 No No Current