Home NDC 0517-2325 Venofer
Product NDC 0517-2325
11-digit product format 005172325
Labeler code 0517
Product ID 0517-2325_500b09f8-36f1-4842-8d07-246fea7bdfd0
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name iron sucrose
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler American Regent, Inc.
Application NDA021135
Marketing category NDA
Marketing start 2011-01-27
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 43 .
Orange Book products# Current product rows page 1 of 1 · 5 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N021135-001 VENOFER IRON SUCROSE EQ 100MG IRON/5ML (EQ 20MG IRON/ML) INJECTABLE / INTRAVENOUS AB RLD, RS 2000-11-06 N021135-002 VENOFER IRON SUCROSE EQ 50MG IRON/2.5ML (EQ 20MG IRON/ML) INJECTABLE / INTRAVENOUS AB RLD 2005-03-20 N021135-003 VENOFER IRON SUCROSE EQ 75MG IRON/3.75ML (EQ 20MG IRON/ML) INJECTABLE / INTRAVENOUS 2005-03-29 N021135-004 VENOFER IRON SUCROSE EQ 200MG IRON/10ML (EQ 20MG IRON/ML) INJECTABLE / INTRAVENOUS AB RLD 2007-02-09 N021135-005 VENOFER IRON SUCROSE EQ 65MG IRON/3.25ML (EQ 20MG IRON/ML) INJECTABLE / INTRAVENOUS 2013-03-29
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.
Product history page 1 of 6 · 215 observed 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 N021135-001 VENOFER EQ 100MG IRON/5ML (EQ 20MG IRON/ML) INJECTABLE / INTRAVENOUS AB RLD, RS 2000-11-06 84e616aacf4f…2026-09-14 22:38:34 2026-08 N021135-002 VENOFER EQ 50MG IRON/2.5ML (EQ 20MG IRON/ML) INJECTABLE / INTRAVENOUS AB RLD 2005-03-20 84e616aacf4f…2026-09-14 22:38:34 2026-08 N021135-003 VENOFER EQ 75MG IRON/3.75ML (EQ 20MG IRON/ML) INJECTABLE / INTRAVENOUS 2005-03-29 84e616aacf4f…2026-09-14 22:38:34 2026-08 N021135-004 VENOFER EQ 200MG IRON/10ML (EQ 20MG IRON/ML) INJECTABLE / INTRAVENOUS AB RLD 2007-02-09 84e616aacf4f…2026-09-14 22:38:34 2026-08 N021135-005 VENOFER EQ 65MG IRON/3.25ML (EQ 20MG IRON/ML) INJECTABLE / INTRAVENOUS 2013-03-29 84e616aacf4f…2026-08-18 06:07:40 2026-07 N021135-001 VENOFER EQ 100MG IRON/5ML (EQ 20MG IRON/ML) INJECTABLE / INTRAVENOUS AB RLD, RS 2000-11-06 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N021135-002 VENOFER EQ 50MG IRON/2.5ML (EQ 20MG IRON/ML) INJECTABLE / INTRAVENOUS AB RLD 2005-03-20 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N021135-003 VENOFER EQ 75MG IRON/3.75ML (EQ 20MG IRON/ML) INJECTABLE / INTRAVENOUS 2005-03-29 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N021135-004 VENOFER EQ 200MG IRON/10ML (EQ 20MG IRON/ML) INJECTABLE / INTRAVENOUS AB RLD 2007-02-09 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N021135-005 VENOFER EQ 65MG IRON/3.25ML (EQ 20MG IRON/ML) INJECTABLE / INTRAVENOUS 2013-03-29 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N021135-001 VENOFER EQ 100MG IRON/5ML (EQ 20MG IRON/ML) INJECTABLE / INTRAVENOUS AB RLD, RS 2000-11-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021135-002 VENOFER EQ 50MG IRON/2.5ML (EQ 20MG IRON/ML) INJECTABLE / INTRAVENOUS AB RLD 2005-03-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021135-003 VENOFER EQ 75MG IRON/3.75ML (EQ 20MG IRON/ML) INJECTABLE / INTRAVENOUS 2005-03-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021135-004 VENOFER EQ 200MG IRON/10ML (EQ 20MG IRON/ML) INJECTABLE / INTRAVENOUS AB RLD 2007-02-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021135-005 VENOFER EQ 65MG IRON/3.25ML (EQ 20MG IRON/ML) INJECTABLE / INTRAVENOUS 2013-03-29 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021135-001 VENOFER EQ 100MG IRON/5ML (EQ 20MG IRON/ML) INJECTABLE / INTRAVENOUS AB RLD, RS 2000-11-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021135-002 VENOFER EQ 50MG IRON/2.5ML (EQ 20MG IRON/ML) INJECTABLE / INTRAVENOUS AB RLD 2005-03-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021135-003 VENOFER EQ 75MG IRON/3.75ML (EQ 20MG IRON/ML) INJECTABLE / INTRAVENOUS 2005-03-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021135-004 VENOFER EQ 200MG IRON/10ML (EQ 20MG IRON/ML) INJECTABLE / INTRAVENOUS AB RLD 2007-02-09 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021135-005 VENOFER EQ 65MG IRON/3.25ML (EQ 20MG IRON/ML) INJECTABLE / INTRAVENOUS 2013-03-29 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N021135-001 VENOFER EQ 100MG IRON/5ML (EQ 20MG IRON/ML) INJECTABLE / INTRAVENOUS RLD, RS 2000-11-06 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021135-002 VENOFER EQ 50MG IRON/2.5ML (EQ 20MG IRON/ML) INJECTABLE / INTRAVENOUS RLD 2005-03-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021135-003 VENOFER EQ 75MG IRON/3.75ML (EQ 20MG IRON/ML) INJECTABLE / INTRAVENOUS 2005-03-29 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021135-004 VENOFER EQ 200MG IRON/10ML (EQ 20MG IRON/ML) INJECTABLE / INTRAVENOUS RLD 2007-02-09 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021135-005 VENOFER EQ 65MG IRON/3.25ML (EQ 20MG IRON/ML) INJECTABLE / INTRAVENOUS 2013-03-29 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021135-001 VENOFER EQ 100MG IRON/5ML (EQ 20MG IRON/ML) INJECTABLE / INTRAVENOUS RLD, RS 2000-11-06 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021135-002 VENOFER EQ 50MG IRON/2.5ML (EQ 20MG IRON/ML) INJECTABLE / INTRAVENOUS RLD 2005-03-20 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021135-003 VENOFER EQ 75MG IRON/3.75ML (EQ 20MG IRON/ML) INJECTABLE / INTRAVENOUS 2005-03-29 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021135-004 VENOFER EQ 200MG IRON/10ML (EQ 20MG IRON/ML) INJECTABLE / INTRAVENOUS RLD 2007-02-09 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021135-005 VENOFER EQ 65MG IRON/3.25ML (EQ 20MG IRON/ML) INJECTABLE / INTRAVENOUS 2013-03-29 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021135-001 VENOFER EQ 100MG IRON/5ML (EQ 20MG IRON/ML) INJECTABLE / INTRAVENOUS RLD, RS 2000-11-06 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021135-002 VENOFER EQ 50MG IRON/2.5ML (EQ 20MG IRON/ML) INJECTABLE / INTRAVENOUS RLD 2005-03-20 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021135-003 VENOFER EQ 75MG IRON/3.75ML (EQ 20MG IRON/ML) INJECTABLE / INTRAVENOUS 2005-03-29 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021135-004 VENOFER EQ 200MG IRON/10ML (EQ 20MG IRON/ML) INJECTABLE / INTRAVENOUS RLD 2007-02-09 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021135-005 VENOFER EQ 65MG IRON/3.25ML (EQ 20MG IRON/ML) INJECTABLE / INTRAVENOUS 2013-03-29 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021135-001 VENOFER EQ 100MG IRON/5ML (EQ 20MG IRON/ML) INJECTABLE / INTRAVENOUS RLD, RS 2000-11-06 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021135-002 VENOFER EQ 50MG IRON/2.5ML (EQ 20MG IRON/ML) INJECTABLE / INTRAVENOUS RLD 2005-03-20 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021135-003 VENOFER EQ 75MG IRON/3.75ML (EQ 20MG IRON/ML) INJECTABLE / INTRAVENOUS 2005-03-29 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021135-004 VENOFER EQ 200MG IRON/10ML (EQ 20MG IRON/ML) INJECTABLE / INTRAVENOUS RLD 2007-02-09 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021135-005 VENOFER EQ 65MG IRON/3.25ML (EQ 20MG IRON/ML) INJECTABLE / INTRAVENOUS 2013-03-29 03ed91905a0d…
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 Venofer
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 · 6 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1741261 Internal RxNorm lookup 1741263 Internal RxNorm lookup 1741267 Internal RxNorm lookup 1741268 Internal RxNorm lookup 1741270 Internal RxNorm lookup 1741271 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 0517-2325-01 Venofer 2.5 mL in 1 VIAL, SINGLE-DOSE INJECTION, SOLUTION 2.5 45 0517-2325-10 Venofer 10 in 1 BOX INJECTION, SOLUTION 10 45
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0517-2325 VENOFER (IRON SUCROSE) INJECTION, SOLUTION [AMERICAN REGENT, INC.] 44 Current NDC, Legacy NDC, 2 package rows 20240904_626dc9e5-c6b4-4f9c-9bf4-774fd3ae619a.zip
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 · 4 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Venofer IRON SUCROSE American Regent, Inc. b998ef36-81fa-40a1-9cd1-6d6156f91564 2026-03-01 Warnings, Adverse reactions Exact identifier application applno (NDA): 021135 application number: NDA021135 Venofer IRON SUCROSE American Regent, Inc. 626dc9e5-c6b4-4f9c-9bf4-774fd3ae619a 2026-03-01 Warnings, Adverse reactions Exact identifier application applno (NDA): 021135 application number: NDA021135 ndc (product): 0517-2325 VENOFER (IRON SUCROSE) VENOFER (IRON SUCROSE) HF Acquisition Co LLC, DBA HealthFirst c59cb54c-bee5-96d6-e053-2995a90a767c 2024-04-19 Warnings, Adverse reactions Exact identifier application applno (NDA): 021135 application number: NDA021135 Venofer IRON SUCROSE Fresenius Medical Care Holdings, Inc. f1ab1a22-2b99-4d27-8b5a-9c3bcd5e3040 2022-06-01 Warnings, Adverse reactions Exact identifier application applno (NDA): 021135 application number: NDA021135
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0517-2325-01 00517232501 2.5 mL in 1 VIAL, SINGLE-DOSE 2.5 ml Historical 0517-2325-10 00517232510 10 VIAL, SINGLE-DOSE in 1 BOX (0517-2325-10) / 2.5 mL in 1 VIAL, SINGLE-DOSE (0517-2325-01) 2011-01-27 0000-00-00 No No Current