Home NDC 49230-534 Venofer
Product NDC 49230-534
11-digit product format 492300534
Labeler code 49230
Product ID 49230-534_e12cb876-ae80-416b-9bd3-a1cc83c9e666
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name iron sucrose
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler Fresenius Medical Care Holdings, Inc.
Application NDA021135
Marketing category NDA
Marketing start 2008-11-04
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 2026-12-31
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 2026-12-31 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 · 4 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 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 49230-534-01 Venofer 5 mL in 1 VIAL, SINGLE-DOSE INJECTION, SOLUTION 5 29 49230-534-10 Venofer 10 in 1 BOX INJECTION, SOLUTION 10 29 49230-534-25 Venofer 25 in 1 TRAY INJECTION, SOLUTION 25 29
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 49230-534 VENOFER (IRON SUCROSE) INJECTION, SOLUTION [FRESENIUS MEDICAL CARE HOLDINGS, INC.] 28 Current NDC, Legacy NDC, 3 package rows 20241121_f1ab1a22-2b99-4d27-8b5a-9c3bcd5e3040.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 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 ndc (product): 49230-534
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 49230-534-01 49230053401 5 mL in 1 VIAL, SINGLE-DOSE 5 ml Historical 49230-534-10 49230053410 10 VIAL, SINGLE-DOSE in 1 BOX (49230-534-10) / 5 mL in 1 VIAL, SINGLE-DOSE (49230-534-01) 2008-11-04 0000-00-00 No No Current 49230-534-25 49230053425 25 VIAL, SINGLE-DOSE in 1 TRAY (49230-534-25) / 5 mL in 1 VIAL, SINGLE-DOSE (49230-534-01) 2008-11-04 0000-00-00 No No Current