IRON DEXTRAN

Product NDC: 51662-1441
11-digit product format: 516621441
Labeler code: 51662
Product ID: 51662-1441_2b3948f4-fdef-5321-e063-6394a90ad70c
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: IRON DEXTRAN
Dosage form: INJECTION
Route: INTRAMUSCULAR; INTRAVENOUS
Labeler: HF Acquisition Co LLC, DBA HealthFirst
Application: NDA017441
Marketing category: NDA
Marketing start: 2019-12-22
Substance: IRON DEXTRAN
Active strength: 50 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 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N017441-001	INFED	IRON DEXTRAN	EQ 100MG IRON/2ML (EQ 50MG IRON/ML)	INJECTABLE / INJECTION	BP	RLD, RS, Approved before 1982

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
N017441-001	BP

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 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N017441-001	INFED	EQ 100MG IRON/2ML (EQ 50MG IRON/ML)	INJECTABLE / INJECTION	BP	RLD, RS, Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N017441-001	INFED	EQ 100MG IRON/2ML (EQ 50MG IRON/ML)	INJECTABLE / INJECTION	BP	RLD, RS, Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N017441-001	INFED	EQ 100MG IRON/2ML (EQ 50MG IRON/ML)	INJECTABLE / INJECTION	BP	RLD, RS, Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N017441-001	INFED	EQ 100MG IRON/2ML (EQ 50MG IRON/ML)	INJECTABLE / INJECTION	BP	RLD, RS, Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N017441-001	INFED	EQ 100MG IRON/2ML (EQ 50MG IRON/ML)	INJECTABLE / INJECTION	BP	RLD, RS, Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N017441-001	INFED	EQ 100MG IRON/2ML (EQ 50MG IRON/ML)	INJECTABLE / INJECTION	BP	RLD, RS, Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N017441-001	INFED	EQ 100MG IRON/2ML (EQ 50MG IRON/ML)	INJECTABLE / INJECTION	BP	RLD, RS, Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N017441-001	INFED	EQ 100MG IRON/2ML (EQ 50MG IRON/ML)	INJECTABLE / INJECTION	BP	RLD, RS, Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N017441-001	INFED	EQ 100MG IRON/2ML (EQ 50MG IRON/ML)	INJECTABLE / INJECTION	BP	RLD, RS, Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N017441-001	INFED	EQ 100MG IRON/2ML (EQ 50MG IRON/ML)	INJECTABLE / INJECTION	BP	RLD, RS, Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N017441-001	INFED	EQ 100MG IRON/2ML (EQ 50MG IRON/ML)	INJECTABLE / INJECTION	BP	RLD, RS, Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N017441-001	INFED	EQ 100MG IRON/2ML (EQ 50MG IRON/ML)	INJECTABLE / INJECTION	BP	RLD, RS, Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N017441-001	INFED	EQ 100MG IRON/2ML (EQ 50MG IRON/ML)	INJECTABLE / INJECTION	BP	RLD, RS, Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N017441-001	INFED	EQ 100MG IRON/2ML (EQ 50MG IRON/ML)	INJECTABLE / INJECTION	BP	RLD, RS, Approved before 1982	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N017441-001	INFED	EQ 100MG IRON/2ML (EQ 50MG IRON/ML)	INJECTABLE / INJECTION	BP	RLD, RS, Approved before 1982	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N017441-001	INFED	EQ 100MG IRON/2ML (EQ 50MG IRON/ML)	INJECTABLE / INJECTION	BP	RLD, RS, Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N017441-001	INFED	EQ 100MG IRON/2ML (EQ 50MG IRON/ML)	INJECTABLE / INJECTION	BP	RLD, RS, Approved before 1982	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N017441-001	INFED	EQ 50MG IRON/ML	INJECTABLE / INJECTION	BP	RLD, RS, Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N017441-001	INFED	EQ 100MG IRON/2ML (EQ 50MG IRON/ML)	INJECTABLE / INJECTION	BP	RLD, RS, Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N017441-001	INFED	EQ 100MG IRON/2ML (EQ 50MG IRON/ML)	INJECTABLE / INJECTION	BP	RLD, RS, Approved before 1982	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N017441-001	INFED	EQ 50MG IRON/ML	INJECTABLE / INJECTION	BP	RLD, RS, Approved before 1982	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N017441-001	INFED	EQ 50MG IRON/ML	INJECTABLE / INJECTION	BP	RLD, RS, Approved before 1982	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N017441-001	INFED	EQ 50MG IRON/ML	INJECTABLE / INJECTION	BP	RLD, RS, Approved before 1982	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N017441-001	INFED	EQ 50MG IRON/ML	INJECTABLE / INJECTION	BP	RLD, RS, Approved before 1982	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N017441-001	INFED	EQ 50MG IRON/ML	INJECTABLE / INJECTION	BP	RLD, RS, Approved before 1982	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N017441-001	INFED	EQ 50MG IRON/ML	INJECTABLE / INJECTION	BP	RLD, RS, Approved before 1982	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N017441-001	INFED	EQ 50MG IRON/ML	INJECTABLE / INJECTION	BP	RLD, RS, Approved before 1982	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N017441-001	INFED	EQ 100MG IRON/2ML (EQ 50MG IRON/ML)	INJECTABLE / INJECTION	BP	RLD, RS, Approved before 1982	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N017441-001	INFED	EQ 100MG IRON/2ML (EQ 50MG IRON/ML)	INJECTABLE / INJECTION	BP	RLD, RS, Approved before 1982	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N017441-001	INFED	EQ 100MG IRON/2ML (EQ 50MG IRON/ML)	INJECTABLE / INJECTION	BP	RLD, RS, Approved before 1982	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N017441-001	INFED	EQ 100MG IRON/2ML (EQ 50MG IRON/ML)	INJECTABLE / INJECTION	BP	RLD, RS, Approved before 1982	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N017441-001	INFED	EQ 100MG IRON/2ML (EQ 50MG IRON/ML)	INJECTABLE / INJECTION	BP	RLD, RS, Approved before 1982	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N017441-001	INFED	EQ 100MG IRON/2ML (EQ 50MG IRON/ML)	INJECTABLE / INJECTION	BP	RLD, RS, Approved before 1982	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N017441-001	INFED	EQ 100MG IRON/2ML (EQ 50MG IRON/ML)	INJECTABLE / INJECTION	BP	RLD, RS, Approved before 1982	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N017441-001	INFED	EQ 100MG IRON/2ML (EQ 50MG IRON/ML)	INJECTABLE / INJECTION	BP	RLD, RS, Approved before 1982	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N017441-001	INFED	EQ 100MG IRON/2ML (EQ 50MG IRON/ML)	INJECTABLE / INJECTION	BP	RLD, RS, Approved before 1982	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N017441-001	INFED	EQ 100MG IRON/2ML (EQ 50MG IRON/ML)	INJECTABLE / INJECTION	BP	RLD, RS, Approved before 1982	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N017441-001	INFED	EQ 100MG IRON/2ML (EQ 50MG IRON/ML)	INJECTABLE / INJECTION	BP	RLD, RS, Approved before 1982	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N017441-001	INFED	EQ 100MG IRON/2ML (EQ 50MG IRON/ML)	INJECTABLE / INJECTION	BP	RLD, RS, Approved before 1982	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N017441-001	INFED	EQ 100MG IRON/2ML (EQ 50MG IRON/ML)	INJECTABLE / INJECTION	BP	RLD, RS, Approved before 1982	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N017441-001	BP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N017441-001	BP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N017441-001	BP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N017441-001	BP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N017441-001	BP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N017441-001	BP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N017441-001	BP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N017441-001	BP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N017441-001	BP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N017441-001	BP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N017441-001	BP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N017441-001	BP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N017441-001	BP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N017441-001	BP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N017441-001	BP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N017441-001	BP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N017441-001	BP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N017441-001	BP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N017441-001	BP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N017441-001	BP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N017441-001	BP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N017441-001	BP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N017441-001	BP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N017441-001	BP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N017441-001	BP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N017441-001	BP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N017441-001	BP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N017441-001	BP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N017441-001	BP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N017441-001	BP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N017441-001	BP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N017441-001	BP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N017441-001	BP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N017441-001	BP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N017441-001	BP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N017441-001	BP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N017441-001	BP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N017441-001	BP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N017441-001	BP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N017441-001	BP	1	`cb3db0bc1861…`

Additional Listing Data#

Finished product: Yes
Brand name base: IRON DEXTRAN
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
IRON DEXTRAN	50 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
95HR524N2M	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
311144	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
9a4cd424-865d-fdd1-e053-2995a90a00ff	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	Strength	SPL version
51662-1441-1	IRON DEXTRAN	2 mL in 1 VIAL, SINGLE-DOSE	INJECTION	2		3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
51662-1441	IRON DEXTRAN INJECTION [HF ACQUISITION CO LLC, DBA HEALTHFIRST]	3	Current NDC, Legacy NDC, 1 package rows	20250110_9a4cd424-865d-fdd1-e053-2995a90a00ff.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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
INFED	IRON DEXTRAN	Henry Schein, Inc.	99bf34be-cb8a-46d1-9637-5544dc2da287	2026-04-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 017441 application number: NDA017441
IRON DEXTRAN	IRON DEXTRAN	HF Acquisition Co LLC, DBA HealthFirst	9a4cd424-865d-fdd1-e053-2995a90a00ff	2025-01-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 017441 application number: NDA017441 ndc (product): 51662-1441
INFeD	IRON DEXTRAN	Allergan, Inc.	94b01b1e-794b-4bea-8e24-2e54683fc023	2024-08-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 017441 application number: NDA017441

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
95HR524N2M	IRON DEXTRAN	9004-66-4	IRON DEXTRAN

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
311144	iron dextran 100 MG in 2 ML Injection	PSN	9a4cd424-865d-fdd1-e053-2995a90a00ff	3
311144	2 ML iron-dextran complex 50 MG/ML Injection	SCD	9a4cd424-865d-fdd1-e053-2995a90a00ff	3
311144	iron dextran (as iron) 100 MG per 2 ML Injection	SY	9a4cd424-865d-fdd1-e053-2995a90a00ff	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
51662-1441-1	51662144101	2 mL in 1 VIAL, SINGLE-DOSE (51662-1441-1)	2 ml	2019-12-22	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
INFED(R) (IRON DEXTRAN INJECTION, USP) 100mg elemental iron/2mL (50mg/mL) 2mL VIAL	HF Acquisition Co LLC, DBA HealthFirst	2025-01-08	HUMAN PRESCRIPTION DRUG LABEL	3