Home NDC 76329-9201 Iron Sucrose
Product NDC 76329-9201
11-digit product format 763299201
Labeler code 76329
Product ID 76329-9201_8fa02679-e3f5-44d2-b074-7003d6cf070b
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Iron Sucrose
Dosage form INJECTION
Route INTRAVENOUS
Labeler International Medication Systems, Limited
Application ANDA208977
Marketing category ANDA
Marketing start 2025-08-12
Substance IRON SUCROSE
Active strength 20 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 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 A208977-001 IRON SUCROSE IRON SUCROSE EQ 50MG IRON/2.5ML (EQ 20MG IRON/ML) INJECTABLE / INTRAVENOUS AB 2025-08-08 A208977-002 IRON SUCROSE IRON SUCROSE EQ 100MG IRON/5ML (EQ 20MG IRON/ML) INJECTABLE / INTRAVENOUS AB 2025-08-08 A208977-003 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 · 1 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration A208977-001 CGT 2026-02-08
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 A208977-001 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 A208977-002 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 A208977-003 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 A208977-001 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 A208977-002 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 A208977-003 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 A208977-001 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 A208977-002 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 A208977-003 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 A208977-001 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 A208977-002 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 A208977-003 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 A208977-001 CGT 2026-02-08 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A208977-001 CGT 2026-02-08 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A208977-001 CGT 2026-02-08 31067a03dcf5…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A208977-001 CGT 2026-02-08 a50c72e98297…
Additional Listing Data#
Finished product Yes
Brand name base Iron Sucrose
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength IRON SUCROSE 20 mg/mL
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# 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 Marketing start Sample Exclude flag Status 76329-9201-1 76329920101 10 VIAL, SINGLE-DOSE in 1 PACKAGE (76329-9201-1) / 5 mL in 1 VIAL, SINGLE-DOSE 2025-08-12 No No Current 76329-9201-5 76329920105 20 VIAL, SINGLE-DOSE in 1 PACKAGE (76329-9201-5) / 5 mL in 1 VIAL, SINGLE-DOSE 2026-05-11 No No Current