Cyclophosphamide

Product NDC: 0338-9779
11-digit product format: 003389779
Labeler code: 0338
Product ID: 0338-9779_4f8ec65c-284b-4a7e-86d6-d3ced9cef625
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: cyclophosphamide injection, solution
Dosage form: INJECTION
Route: INTRAVENOUS
Labeler: Baxter Healthcare Company
Application: NDA217651
Marketing category: NDA
Marketing start: 2024-08-01
Substance: CYCLOPHOSPHAMIDE
Active strength: 200 mg/mL
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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N217651-001	CYCLOPHOSPHAMIDE	CYCLOPHOSPHAMIDE	500MG/2.5ML (200MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2023-06-28
N217651-002	CYCLOPHOSPHAMIDE	CYCLOPHOSPHAMIDE	1GM/5ML (200MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2023-06-28

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 · 44 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N217651-001	CYCLOPHOSPHAMIDE	500MG/2.5ML (200MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-06-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217651-002	CYCLOPHOSPHAMIDE	1GM/5ML (200MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-06-28	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N217651-001	CYCLOPHOSPHAMIDE	500MG/2.5ML (200MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-06-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217651-002	CYCLOPHOSPHAMIDE	1GM/5ML (200MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-06-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N217651-001	CYCLOPHOSPHAMIDE	500MG/2.5ML (200MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-06-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N217651-002	CYCLOPHOSPHAMIDE	1GM/5ML (200MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-06-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N217651-001	CYCLOPHOSPHAMIDE	500MG/2.5ML (200MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-06-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N217651-002	CYCLOPHOSPHAMIDE	1GM/5ML (200MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-06-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N217651-001	CYCLOPHOSPHAMIDE	500MG/2.5ML (200MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-06-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N217651-002	CYCLOPHOSPHAMIDE	1GM/5ML (200MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-06-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N217651-001	CYCLOPHOSPHAMIDE	500MG/2.5ML (200MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-06-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N217651-002	CYCLOPHOSPHAMIDE	1GM/5ML (200MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-06-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N217651-001	CYCLOPHOSPHAMIDE	500MG/2.5ML (200MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-06-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N217651-002	CYCLOPHOSPHAMIDE	1GM/5ML (200MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-06-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N217651-001	CYCLOPHOSPHAMIDE	500MG/2.5ML (200MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-06-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N217651-002	CYCLOPHOSPHAMIDE	1GM/5ML (200MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-06-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N217651-001	CYCLOPHOSPHAMIDE	500MG/2.5ML (200MG/ML)	SOLUTION / INTRAVENOUS	RLD	2023-06-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N217651-002	CYCLOPHOSPHAMIDE	1GM/5ML (200MG/ML)	SOLUTION / INTRAVENOUS	RLD	2023-06-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N217651-001	CYCLOPHOSPHAMIDE	500MG/2.5ML (200MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-06-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N217651-002	CYCLOPHOSPHAMIDE	1GM/5ML (200MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-06-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N217651-001	CYCLOPHOSPHAMIDE	500MG/2.5ML (200MG/ML)	SOLUTION / INTRAVENOUS	RLD	2023-06-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N217651-002	CYCLOPHOSPHAMIDE	1GM/5ML (200MG/ML)	SOLUTION / INTRAVENOUS	RLD	2023-06-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N217651-001	CYCLOPHOSPHAMIDE	500MG/2.5ML (200MG/ML)	SOLUTION / INTRAVENOUS	RLD	2023-06-28	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N217651-002	CYCLOPHOSPHAMIDE	1GM/5ML (200MG/ML)	SOLUTION / INTRAVENOUS	RLD	2023-06-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N217651-001	CYCLOPHOSPHAMIDE	500MG/2.5ML (200MG/ML)	SOLUTION / INTRAVENOUS	RLD	2023-06-28	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N217651-002	CYCLOPHOSPHAMIDE	1GM/5ML (200MG/ML)	SOLUTION / INTRAVENOUS	RLD	2023-06-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N217651-001	CYCLOPHOSPHAMIDE	500MG/2.5ML (200MG/ML)	SOLUTION / INTRAVENOUS	RLD	2023-06-28	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N217651-002	CYCLOPHOSPHAMIDE	1GM/5ML (200MG/ML)	SOLUTION / INTRAVENOUS	RLD	2023-06-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N217651-001	CYCLOPHOSPHAMIDE	500MG/2.5ML (200MG/ML)	SOLUTION / INTRAVENOUS	RLD	2023-06-28	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N217651-002	CYCLOPHOSPHAMIDE	1GM/5ML (200MG/ML)	SOLUTION / INTRAVENOUS	RLD	2023-06-28	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N217651-001	CYCLOPHOSPHAMIDE	500MG/2.5ML (200MG/ML)	SOLUTION / INTRAVENOUS	RLD	2023-06-28	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N217651-002	CYCLOPHOSPHAMIDE	1GM/5ML (200MG/ML)	SOLUTION / INTRAVENOUS	RLD	2023-06-28	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N217651-001	CYCLOPHOSPHAMIDE	500MG/2.5ML (200MG/ML)	SOLUTION / INTRAVENOUS	RLD	2023-06-28	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	N217651-002	CYCLOPHOSPHAMIDE	1GM/5ML (200MG/ML)	SOLUTION / INTRAVENOUS	RLD	2023-06-28	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N217651-001	CYCLOPHOSPHAMIDE	500MG/2.5ML (200MG/ML)	SOLUTION / INTRAVENOUS	RLD	2023-06-28	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N217651-002	CYCLOPHOSPHAMIDE	1GM/5ML (200MG/ML)	SOLUTION / INTRAVENOUS	RLD	2023-06-28	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N217651-001	CYCLOPHOSPHAMIDE	500MG/2.5ML (200MG/ML)	SOLUTION / INTRAVENOUS	RLD	2023-06-28	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N217651-002	CYCLOPHOSPHAMIDE	1GM/5ML (200MG/ML)	SOLUTION / INTRAVENOUS	RLD	2023-06-28	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N217651-001	CYCLOPHOSPHAMIDE	500MG/2.5ML (200MG/ML)	SOLUTION / INTRAVENOUS	RLD	2023-06-28	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N217651-002	CYCLOPHOSPHAMIDE	1GM/5ML (200MG/ML)	SOLUTION / INTRAVENOUS	RLD	2023-06-28	`9b2671bbb829…`

Additional Listing Data#

Finished product: Yes
Brand name base: Cyclophosphamide
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
CYCLOPHOSPHAMIDE	200 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
8N3DW7272P	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
2386859	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
34dbffee-80e0-49c3-90e8-95713a0b7fbe	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
0db1850b-2dc3-47a1-8b35-fab6e1685124	Product name	3	20250814
0b38b013-6fe7-0a7a-ece2-0a10ca467a97	Product name	4	20250801
f22fb018-dc36-4ffa-a765-94776b98899b	Product name	1	20250620
e71baeca-a07a-452b-ba2b-50be55aedc79	Product name	2	20250617
913f6711-71c9-4a3d-a6d5-98cbd101b5d8	Product name	1	20231023
cd3d0a71-dbf2-4640-91f7-c99c45edfbb6	Product name	1	20231023
fbc3d08d-10bd-4e59-b59d-d530aede5bad	Product name	1	20220308

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0338-9779-01	Cyclophosphamide	1 in 1 CARTON	INJECTION	1		2
0338-9779-01	Cyclophosphamide	5 mL in 1 VIAL	INJECTION	5		2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0338-9779-01	ML - Milliliter	0338-9779	47d963df-2c8f-4d70-81a7-9848106795eb	1	2024-12-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0338-9779	CYCLOPHOSPHAMIDE (CYCLOPHOSPHAMIDE INJECTION, SOLUTION) INJECTION [BAXTER HEALTHCARE COMPANY]	2	Current NDC, 2 package rows	20250416_34dbffee-80e0-49c3-90e8-95713a0b7fbe.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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Cyclophosphamide	CYCLOPHOSPHAMIDE INJECTION, SOLUTION	Baxter Healthcare Company	34dbffee-80e0-49c3-90e8-95713a0b7fbe	2024-04-10	Warnings, Adverse reactions	Exact identifier application applno (NDA): 217651 application number: NDA217651 ndc (product): 0338-9779

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
8N3DW7272P	CYCLOPHOSPHAMIDE	6055-19-2	CYCLOPHOSPHAMIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2386859	cycloPHOSphamide 200 MG/ML Injectable Solution	PSN	34dbffee-80e0-49c3-90e8-95713a0b7fbe	3
2386859	cyclophosphamide 200 MG/ML Injectable Solution	SCD	34dbffee-80e0-49c3-90e8-95713a0b7fbe	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
0338-9779-01	00338977901	1 VIAL in 1 CARTON (0338-9779-01) / 5 mL in 1 VIAL	1 vial	2024-08-01	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
cyclophosphamide injection, solution	Baxter Healthcare Company	2024-04-10	HUMAN PRESCRIPTION DRUG LABEL	3