Venofer

Product NDC: 49230-530
11-digit product format: 492300530
Labeler code: 49230
Product ID: 49230-530_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: 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: 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 · 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.

Application-product, TE code table
Application-product	TE code
N021135-001	AB
N021135-002	AB
N021135-004	AB

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 · 210 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
2026-08-18 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…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021135-001	VENOFER	EQ 100MG IRON/5ML (EQ 20MG IRON/ML)	INJECTABLE / INTRAVENOUS		RLD, RS	2000-11-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021135-002	VENOFER	EQ 50MG IRON/2.5ML (EQ 20MG IRON/ML)	INJECTABLE / INTRAVENOUS		RLD	2005-03-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021135-003	VENOFER	EQ 75MG IRON/3.75ML (EQ 20MG IRON/ML)	INJECTABLE / INTRAVENOUS			2005-03-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021135-004	VENOFER	EQ 200MG IRON/10ML (EQ 20MG IRON/ML)	INJECTABLE / INTRAVENOUS		RLD	2007-02-09	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021135-005	VENOFER	EQ 65MG IRON/3.25ML (EQ 20MG IRON/ML)	INJECTABLE / INTRAVENOUS			2013-03-29	`2680178bc6a6…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	N021135-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021135-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021135-004	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021135-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021135-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021135-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021135-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021135-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021135-004	AB	1	`31067a03dcf5…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N021135-001	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N021135-002	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N021135-004	AB	1	`a50c72e98297…`

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.

Identifier, FDA.report destination table
Identifier	FDA.report destination
f1ab1a22-2b99-4d27-8b5a-9c3bcd5e3040	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
04cdd491-d111-4bc2-9549-75c575e1bd4b	Product name	1	20200714
8390fb8b-6c75-416c-a9a1-70e8ed493b73	Product name	1	20200611
96a528e9-23e2-495f-81b9-ae87df2f7552	Product name	1	20191120
3df56c93-5837-4523-aac2-4b1ec48b9676	Product name	2	20160719
a883b7cc-d320-41d7-92ae-c873457ae641	Product name	1	20151116
bb23e78e-9e64-4037-a1c1-0e1d8762700e	Product name	1	20150325
ef06c001-572c-d95e-42f6-ee83da75673a	Product name	1	20140508
fd21f957-6863-d07b-5a35-250186878716	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
49230-530-01	Venofer	2.5 mL in 1 VIAL, SINGLE-DOSE	INJECTION, SOLUTION	2.5	29
49230-530-10	Venofer	10 in 1 BOX	INJECTION, SOLUTION	10	29
49230-530-25	Venofer	25 in 1 TRAY	INJECTION, SOLUTION	25	29

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
49230-530-10	ML - Milliliter	49230-530	641edeb5-d02d-4ede-a33e-399e2e037649	1	2012-07-24
49230-530-25	ML - Milliliter	49230-530	0be0ff77-08da-42a6-9f9c-dde61182f66b	1	2014-09-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
IRON SUCROSE	ACTIVE INGREDIENT	FZ7NYF5N8L	VENOFER (IRON SUCROSE) INJECTION, SOLUTION [FRESENIUS MEDICAL CARE NORTH AMERICA]	9
FERRIC CATION	ACTIVE MOIETY	91O4LML611	VENOFER (IRON SUCROSE) INJECTION, SOLUTION [FRESENIUS MEDICAL CARE NORTH AMERICA]	9
WATER	INACTIVE INGREDIENT	059QF0KO0R	VENOFER (IRON SUCROSE) INJECTION, SOLUTION [FRESENIUS MEDICAL CARE NORTH AMERICA]	9

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
49230-530	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): 49230-530

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
FZ7NYF5N8L	IRON SUCROSE	8047-67-4	IRON SUCROSE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1741267	iron (as iron sucrose) 100 MG in 5 ML Injection	PSN	f1ab1a22-2b99-4d27-8b5a-9c3bcd5e3040	29
1741270	iron (as iron sucrose) 50 MG in 2.5 mL Injection	PSN	f1ab1a22-2b99-4d27-8b5a-9c3bcd5e3040	29
1741268	Venofer (iron) 100 MG in 5 mL Injection	PSN	f1ab1a22-2b99-4d27-8b5a-9c3bcd5e3040	29
1741271	Venofer (iron) 50 MG in 2.5 mL Injection	PSN	f1ab1a22-2b99-4d27-8b5a-9c3bcd5e3040	29
1741271	2.5 ML iron sucrose 20 MG/ML Injection [Venofer]	SBD	f1ab1a22-2b99-4d27-8b5a-9c3bcd5e3040	29
1741268	5 ML iron sucrose 20 MG/ML Injection [Venofer]	SBD	f1ab1a22-2b99-4d27-8b5a-9c3bcd5e3040	29
1741270	2.5 ML iron sucrose 20 MG/ML Injection	SCD	f1ab1a22-2b99-4d27-8b5a-9c3bcd5e3040	29
1741267	5 ML iron sucrose 20 MG/ML Injection	SCD	f1ab1a22-2b99-4d27-8b5a-9c3bcd5e3040	29
1741271	2.5 ML Venofer 20 MG/ML Injection	SY	f1ab1a22-2b99-4d27-8b5a-9c3bcd5e3040	29
1741268	5 ML Venofer 20 MG/ML Injection	SY	f1ab1a22-2b99-4d27-8b5a-9c3bcd5e3040	29
1741267	ferric oxide, saccharated 100 MG per 5 ML Injection	SY	f1ab1a22-2b99-4d27-8b5a-9c3bcd5e3040	29
1741270	ferric oxide, saccharated 50 MG per 2.5 ML Injection	SY	f1ab1a22-2b99-4d27-8b5a-9c3bcd5e3040	29
1741267	iron (as iron sucrose) 100 MG per 5 ML Injection	SY	f1ab1a22-2b99-4d27-8b5a-9c3bcd5e3040	29
1741270	iron (as iron sucrose) 50 MG per 2.5 ML Injection	SY	f1ab1a22-2b99-4d27-8b5a-9c3bcd5e3040	29
1741268	Venofer (iron) 100 MG per 5 ML Injection	SY	f1ab1a22-2b99-4d27-8b5a-9c3bcd5e3040	29
1741271	Venofer 50 MG per 2.5 ML Injection	SY	f1ab1a22-2b99-4d27-8b5a-9c3bcd5e3040	29

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
49230-530-01	49230053001	2.5 mL in 1 VIAL, SINGLE-DOSE	2.5 ml					Historical
49230-530-10	49230053010	10 VIAL, SINGLE-DOSE in 1 BOX (49230-530-10) / 2.5 mL in 1 VIAL, SINGLE-DOSE (49230-530-01)		2011-01-27	0000-00-00	No	No	Current
49230-530-25	49230053025	25 VIAL, SINGLE-DOSE in 1 TRAY (49230-530-25) / 2.5 mL in 1 VIAL, SINGLE-DOSE (49230-530-01)		2011-01-27	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Venofer	Fresenius Medical Care Holdings, Inc. \| American Regent, Inc. \| Vifor (International) Inc.	2022-06-01	HUMAN PRESCRIPTION DRUG LABEL	29