IFOSFAMIDE

Product NDC: 10019-925
Requested package NDC: 10019-925-01
11-digit product format: 100190925
Labeler code: 10019
Product ID: 10019-925_c5e51b55-6487-4513-9c81-eef1e4f0d487
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: IFOSFAMIDE
Dosage form: INJECTION, POWDER, FOR SOLUTION
Route: INTRAVENOUS
Labeler: Baxter Healthcare Company
Application: NDA019763
Marketing category: NDA
Marketing start: 1988-12-30
Substance: IFOSFAMIDE
Active strength: 1 g/20mL
Pharmacologic classes: Alkylating Activity [MoA], Alkylating Drug [EPC]
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 44.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N019763-001	IFEX	IFOSFAMIDE	1GM/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	AP	RLD	1988-12-30
N019763-002	IFEX	IFOSFAMIDE	3GM/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	AP	RLD	1988-12-30
N019763-003	IFEX/MESNEX KIT	IFOSFAMIDE; MESNA	1GM/VIAL;100MG/ML	INJECTABLE / INJECTION			1992-10-10
N019763-004	IFEX/MESNEX KIT	IFOSFAMIDE; MESNA	3GM/VIAL;100MG/ML	INJECTABLE / INJECTION			1992-10-10

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
N019763-001	AP
N019763-002	AP

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 5 · 176 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
2026-10-15 13:18:30	2026-09	N019763-001	IFEX	1GM/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	AP	RLD	1988-12-30	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N019763-002	IFEX	3GM/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	AP	RLD	1988-12-30	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N019763-003	IFEX/MESNEX KIT	1GM/VIAL;100MG/ML	INJECTABLE / INJECTION			1992-10-10	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N019763-004	IFEX/MESNEX KIT	3GM/VIAL;100MG/ML	INJECTABLE / INJECTION			1992-10-10	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N019763-001	IFEX	1GM/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	AP	RLD	1988-12-30	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N019763-002	IFEX	3GM/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	AP	RLD	1988-12-30	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N019763-003	IFEX/MESNEX KIT	1GM/VIAL;100MG/ML	INJECTABLE / INJECTION			1992-10-10	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N019763-004	IFEX/MESNEX KIT	3GM/VIAL;100MG/ML	INJECTABLE / INJECTION			1992-10-10	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N019763-001	IFEX	1GM/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	AP	RLD	1988-12-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N019763-002	IFEX	3GM/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	AP	RLD	1988-12-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N019763-003	IFEX/MESNEX KIT	1GM/VIAL;100MG/ML	INJECTABLE / INJECTION			1992-10-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N019763-004	IFEX/MESNEX KIT	3GM/VIAL;100MG/ML	INJECTABLE / INJECTION			1992-10-10	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N019763-001	IFEX	1GM/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	AP	RLD	1988-12-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019763-002	IFEX	3GM/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	AP	RLD	1988-12-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019763-003	IFEX/MESNEX KIT	1GM/VIAL;100MG/ML	INJECTABLE / INJECTION			1992-10-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019763-004	IFEX/MESNEX KIT	3GM/VIAL;100MG/ML	INJECTABLE / INJECTION			1992-10-10	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019763-001	IFEX	1GM/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	AP	RLD	1988-12-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019763-002	IFEX	3GM/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	AP	RLD	1988-12-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019763-003	IFEX/MESNEX KIT	1GM/VIAL;100MG/ML	INJECTABLE / INJECTION			1992-10-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019763-004	IFEX/MESNEX KIT	3GM/VIAL;100MG/ML	INJECTABLE / INJECTION			1992-10-10	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N019763-001	IFEX	1GM/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	AP	RLD	1988-12-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019763-002	IFEX	3GM/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	AP	RLD	1988-12-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019763-003	IFEX/MESNEX KIT	1GM/VIAL;100MG/ML	INJECTABLE / INJECTION			1992-10-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019763-004	IFEX/MESNEX KIT	3GM/VIAL;100MG/ML	INJECTABLE / INJECTION			1992-10-10	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019763-001	IFEX	1GM/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	AP	RLD	1988-12-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019763-002	IFEX	3GM/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	AP	RLD	1988-12-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019763-003	IFEX/MESNEX KIT	1GM/VIAL;100MG/ML	INJECTABLE / INJECTION			1992-10-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019763-004	IFEX/MESNEX KIT	3GM/VIAL;100MG/ML	INJECTABLE / INJECTION			1992-10-10	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019763-001	IFEX	1GM/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	AP	RLD	1988-12-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019763-002	IFEX	3GM/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	AP	RLD	1988-12-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019763-003	IFEX/MESNEX KIT	1GM/VIAL;100MG/ML	INJECTABLE / INJECTION			1992-10-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019763-004	IFEX/MESNEX KIT	3GM/VIAL;100MG/ML	INJECTABLE / INJECTION			1992-10-10	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019763-001	IFEX	1GM/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	AP	RLD	1988-12-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019763-002	IFEX	3GM/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	AP	RLD	1988-12-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019763-003	IFEX/MESNEX KIT	1GM/VIAL;100MG/ML	INJECTABLE / INJECTION			1992-10-10	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019763-004	IFEX/MESNEX KIT	3GM/VIAL;100MG/ML	INJECTABLE / INJECTION			1992-10-10	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019763-001	IFEX	1GM/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	AP	RLD	1988-12-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019763-002	IFEX	3GM/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	AP	RLD	1988-12-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019763-003	IFEX/MESNEX KIT	1GM/VIAL;100MG/ML	INJECTABLE / INJECTION			1992-10-10	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019763-004	IFEX/MESNEX KIT	3GM/VIAL;100MG/ML	INJECTABLE / INJECTION			1992-10-10	`2680178bc6a6…`

Observed Orange Book normalized TE history#

Normalized TE history page 2 of 3 · 88 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N019763-001	AP	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N019763-002	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N019763-001	AP	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N019763-002	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N019763-001	AP	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N019763-002	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N019763-001	AP	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N019763-002	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N019763-001	AP	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N019763-002	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N019763-001	AP	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N019763-002	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N019763-001	AP	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N019763-002	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N019763-001	AP	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N019763-002	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N019763-001	AP	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N019763-002	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N019763-001	AP	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N019763-002	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N019763-001	AP	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N019763-002	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N019763-001	AP	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	N019763-002	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N019763-001	AP	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N019763-002	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N019763-001	AP	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N019763-002	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N019763-001	AP	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N019763-002	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N019763-001	AP	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N019763-002	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N019763-001	AP	1	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N019763-002	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N019763-001	AP	1	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	N019763-002	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N019763-001	AP	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	N019763-002	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N019763-001	AP	1	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N019763-002	AP	1	`3a93d1ddd44b…`

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: IFOSFAMIDE
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
IFOSFAMIDE	1 g/20mL

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
8f69a53e-f307-eac5-6db4-e38306b396ce	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
10019-925-01	IFOSFAMIDE	1 in 1 CARTON	INJECTION, POWDER, FOR SOLUTION	1		16
10019-925-82	IFOSFAMIDE	20 mL in 1 VIAL, SINGLE-DOSE	INJECTION, POWDER, FOR SOLUTION	20		16

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
10019-925-01	EA - Each	10019-925	e7d632eb-c7e8-46d5-874f-9c8c6794b825	1	2012-07-24
10019-925-82	EA - Each	10019-925	600cdfb5-36ed-4da8-bc3b-9d156a625de7	1	2013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version	Uploaded
IFOSFAMIDE	ACTIVE INGREDIENT	UM20QQM95Y	IFOSFAMIDE INJECTION, POWDER, FOR SOLUTION [BAXTER HEALTHCARE CORPORATION]	5
IFOSFAMIDE	ACTIVE MOIETY	UM20QQM95Y	IFOSFAMIDE INJECTION, POWDER, FOR SOLUTION [BAXTER HEALTHCARE CORPORATION]	5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
10019-925	IFOSFAMIDE INJECTION, POWDER, FOR SOLUTION [BAXTER HEALTHCARE CORPORATION]	15	Current NDC, Legacy NDC, 2 package rows	20250213_91e433a9-6800-43a6-ac13-a49a04a5aecd.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
IFEX	IFOSFAMIDE	Baxter Healthcare Corporation	b7241707-7538-4d1a-91e7-3a25a91e0b9a	2024-12-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 019763 application number: NDA019763
IFOSFAMIDE	IFOSFAMIDE	Baxter Healthcare Company	91e433a9-6800-43a6-ac13-a49a04a5aecd	2024-12-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 019763 application number: NDA019763 ndc (package): 10019-925-01 ndc (product): 10019-925 ndc11 (package): 10019092501
IFOSFAMIDE	IFOSFAMIDE	Baxter Healthcare Company	efb1d03b-2d91-406e-8110-d3a58b8fa7cc	2024-12-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 019763 application number: NDA019763

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
UM20QQM95Y	IFOSFAMIDE	3778-73-2	IFOSFAMIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1791593	ifosfamide 1 GM Injection	PSN	91e433a9-6800-43a6-ac13-a49a04a5aecd	17
1791588	ifosfamide 3 GM Injection	PSN	91e433a9-6800-43a6-ac13-a49a04a5aecd	17
1791593	ifosfamide 1000 MG Injection	SCD	91e433a9-6800-43a6-ac13-a49a04a5aecd	17
1791588	ifosfamide 3000 MG Injection	SCD	91e433a9-6800-43a6-ac13-a49a04a5aecd	17
1791593	ifosfamide 1 GM Injection	SY	91e433a9-6800-43a6-ac13-a49a04a5aecd	17
1791588	ifosfamide 3 GM Injection	SY	91e433a9-6800-43a6-ac13-a49a04a5aecd	17

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
10019-925-01	10019092501	1 VIAL, SINGLE-DOSE in 1 CARTON (10019-925-01) / 20 mL in 1 VIAL, SINGLE-DOSE (10019-925-82)	1988-12-30	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
IFOSFAMIDE	Baxter Healthcare Company \| Baxter Deutschland GmbH	2026-10-07	HUMAN PRESCRIPTION DRUG LABEL	18