Venofer

Product NDC: 50090-4541
Requested package NDC: 50090-4541-0
11-digit product format: 500904541
Labeler code: 50090
Product ID: 50090-4541_64b0125a-f5f0-4180-8636-6914dd79d6d7
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: iron sucrose
Dosage form: INJECTION, SOLUTION
Route: INTRAVENOUS
Labeler: A-S Medication Solutions
Application: NDA021135
Marketing category: NDA
Marketing start: 2000-11-10
Marketing end: 0000-00-00
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: 2022-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	50090-4541	50090-4541-0	I	Inactivated by FDA		2026-08-17

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 15 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	`1332a3947898…`	`d4bfe170f9cd…`

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…`

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
50090-4541-0	2023-01-30	C162847	48780-1	f386c64a-05a3-0266-e053-dadaa90a7c1a	These highlights do not include all the information needed to use VENOFER ® safely and effectively. See full prescribing information for VENOFER. Venofer (iron sucrose) injection, for intravenous use Initial U.S. Approval: 2000

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
50090-4541-0	Venofer	5 mL in 1 VIAL, SINGLE-USE	INJECTION, SOLUTION	5		5

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50090-4541-0	ML - Milliliter	50090-4541	39a4651e-63e6-4252-9bf6-34e86eb9a615	1	2022-07-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50090-4541	VENOFER (IRON SUCROSE) INJECTION, SOLUTION [A-S MEDICATION SOLUTIONS]	5	Legacy NDC, 1 package rows	20210417_fb5f2539-f1ac-44a1-b899-66802576c674.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

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	fb5f2539-f1ac-44a1-b899-66802576c674	5
1741268	Venofer (iron) 100 MG in 5 mL Injection	PSN	fb5f2539-f1ac-44a1-b899-66802576c674	5
1741268	5 ML iron sucrose 20 MG/ML Injection [Venofer]	SBD	fb5f2539-f1ac-44a1-b899-66802576c674	5
1741267	5 ML iron sucrose 20 MG/ML Injection	SCD	fb5f2539-f1ac-44a1-b899-66802576c674	5
1741268	5 ML Venofer 20 MG/ML Injection	SY	fb5f2539-f1ac-44a1-b899-66802576c674	5
1741267	ferric oxide, saccharated 100 MG per 5 ML Injection	SY	fb5f2539-f1ac-44a1-b899-66802576c674	5
1741267	iron (as iron sucrose) 100 MG per 5 ML Injection	SY	fb5f2539-f1ac-44a1-b899-66802576c674	5
1741268	Venofer (iron) 100 MG per 5 ML Injection	SY	fb5f2539-f1ac-44a1-b899-66802576c674	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
50090-4541-0	50090454100	5 mL in 1 VIAL, SINGLE-USE (50090-4541-0)	5 ml	2019-09-20	0000-00-00	No	No	Current