Cyclophosphamide

Product NDC: 68001-696
Requested package NDC: 68001-696-32
11-digit product format: 680010696
Labeler code: 68001
Product ID: 68001-696_4cd3801f-1a1a-33fd-e063-6294a90aa2b0
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: cyclophosphamide
Dosage form: INJECTION, POWDER, FOR SOLUTION
Route: INTRAVENOUS; ORAL
Labeler: BluePoint Laboratories
Application: ANDA218644
Marketing category: ANDA
Marketing start: 2026-03-15
Substance: CYCLOPHOSPHAMIDE
Active strength: 2 g/100mL
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 43.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A218644-001	CYCLOPHOSPHAMIDE	CYCLOPHOSPHAMIDE	500MG/VIAL	INJECTABLE / INJECTION	AP	2024-12-19
A218644-002	CYCLOPHOSPHAMIDE	CYCLOPHOSPHAMIDE	1GM/VIAL	INJECTABLE / INJECTION	AP	2024-12-19
A218644-003	CYCLOPHOSPHAMIDE	CYCLOPHOSPHAMIDE	2GM/VIAL	INJECTABLE / INJECTION	AP	2024-12-19

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A218644-001	AP
A218644-002	AP
A218644-003	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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A218644-001	CYCLOPHOSPHAMIDE	500MG/VIAL	INJECTABLE / INJECTION	AP	2024-12-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A218644-002	CYCLOPHOSPHAMIDE	1GM/VIAL	INJECTABLE / INJECTION	AP	2024-12-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A218644-003	CYCLOPHOSPHAMIDE	2GM/VIAL	INJECTABLE / INJECTION	AP	2024-12-19	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A218644-001	CYCLOPHOSPHAMIDE	500MG/VIAL	INJECTABLE / INJECTION	AP	2024-12-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A218644-002	CYCLOPHOSPHAMIDE	1GM/VIAL	INJECTABLE / INJECTION	AP	2024-12-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A218644-003	CYCLOPHOSPHAMIDE	2GM/VIAL	INJECTABLE / INJECTION	AP	2024-12-19	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A218644-001	CYCLOPHOSPHAMIDE	500MG/VIAL	INJECTABLE / INJECTION	AP	2024-12-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A218644-002	CYCLOPHOSPHAMIDE	1GM/VIAL	INJECTABLE / INJECTION	AP	2024-12-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A218644-003	CYCLOPHOSPHAMIDE	2GM/VIAL	INJECTABLE / INJECTION	AP	2024-12-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A218644-001	CYCLOPHOSPHAMIDE	500MG/VIAL	INJECTABLE / INJECTION	AP	2024-12-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A218644-002	CYCLOPHOSPHAMIDE	1GM/VIAL	INJECTABLE / INJECTION	AP	2024-12-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A218644-003	CYCLOPHOSPHAMIDE	2GM/VIAL	INJECTABLE / INJECTION	AP	2024-12-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A218644-001	CYCLOPHOSPHAMIDE	500MG/VIAL	INJECTABLE / INJECTION	AP	2024-12-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A218644-002	CYCLOPHOSPHAMIDE	1GM/VIAL	INJECTABLE / INJECTION	AP	2024-12-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A218644-003	CYCLOPHOSPHAMIDE	2GM/VIAL	INJECTABLE / INJECTION	AP	2024-12-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A218644-001	CYCLOPHOSPHAMIDE	500MG/VIAL	INJECTABLE / INJECTION	AP	2024-12-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A218644-002	CYCLOPHOSPHAMIDE	1GM/VIAL	INJECTABLE / INJECTION	AP	2024-12-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A218644-003	CYCLOPHOSPHAMIDE	2GM/VIAL	INJECTABLE / INJECTION	AP	2024-12-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A218644-001	CYCLOPHOSPHAMIDE	500MG/VIAL	INJECTABLE / INJECTION	AP	2024-12-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A218644-002	CYCLOPHOSPHAMIDE	1GM/VIAL	INJECTABLE / INJECTION	AP	2024-12-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A218644-003	CYCLOPHOSPHAMIDE	2GM/VIAL	INJECTABLE / INJECTION	AP	2024-12-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A218644-001	CYCLOPHOSPHAMIDE	500MG/VIAL	INJECTABLE / INJECTION	AP	2024-12-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A218644-002	CYCLOPHOSPHAMIDE	1GM/VIAL	INJECTABLE / INJECTION	AP	2024-12-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A218644-003	CYCLOPHOSPHAMIDE	2GM/VIAL	INJECTABLE / INJECTION	AP	2024-12-19	`03ed91905a0d…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A218644-001	CYCLOPHOSPHAMIDE	500MG/VIAL	INJECTABLE / INJECTION	AP	2024-12-19	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A218644-002	CYCLOPHOSPHAMIDE	1GM/VIAL	INJECTABLE / INJECTION	AP	2024-12-19	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A218644-003	CYCLOPHOSPHAMIDE	2GM/VIAL	INJECTABLE / INJECTION	AP	2024-12-19	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A218644-001	AP	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A218644-002	AP	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A218644-003	AP	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A218644-001	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A218644-002	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A218644-003	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A218644-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A218644-002	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A218644-003	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A218644-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A218644-002	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A218644-003	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A218644-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A218644-002	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A218644-003	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A218644-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A218644-002	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A218644-003	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A218644-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A218644-002	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A218644-003	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A218644-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A218644-002	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A218644-003	AP	1	`03ed91905a0d…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A218644-001	AP	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A218644-002	AP	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A218644-003	AP	1	`a50c72e98297…`

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: Cyclophosphamide
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
CYCLOPHOSPHAMIDE	2 g/100mL

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 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1734917	Internal RxNorm lookup
1734919	Internal RxNorm lookup
1734921	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
1d3396d8-4c03-4a28-890a-d87c6c53a74e	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
68001-696-32	Cyclophosphamide	100 mL in 1 VIAL, SINGLE-DOSE	INJECTION, POWDER, FOR SOLUTION	100		1
68001-696-32	Cyclophosphamide	1 in 1 CARTON	INJECTION, POWDER, FOR SOLUTION	1		1

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
Cyclophosphamide	CYCLOPHOSPHAMIDE	BluePoint Laboratories	1d3396d8-4c03-4a28-890a-d87c6c53a74e	2026-03-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 218644 application number: ANDA218644 ndc (package): 68001-696-32 ndc (product): 68001-696 ndc11 (package): 68001069632
Cyclophosphamide	CYCLOPHOSPHAMIDE	Avenacy, LLC	1de02105-9c5b-4d11-bddf-bf8450d88b78	2026-02-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 218644 application number: ANDA218644
Cyclophosphamide	CYCLOPHOSPHAMIDE	Epic Pharma, LLC	988d2f71-1dc7-45b5-b2df-187e68224973	2025-11-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 218644 application number: ANDA218644

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
1734919	cycloPHOSphamide 1 GM Injection	PSN	1d3396d8-4c03-4a28-890a-d87c6c53a74e	1
1734921	cycloPHOSphamide 2 GM Injection	PSN	1d3396d8-4c03-4a28-890a-d87c6c53a74e	1
1734917	cycloPHOSphamide 500 MG Injection	PSN	1d3396d8-4c03-4a28-890a-d87c6c53a74e	1
1734919	cyclophosphamide 1000 MG Injection	SCD	1d3396d8-4c03-4a28-890a-d87c6c53a74e	1
1734921	cyclophosphamide 2000 MG Injection	SCD	1d3396d8-4c03-4a28-890a-d87c6c53a74e	1
1734917	cyclophosphamide 500 MG Injection	SCD	1d3396d8-4c03-4a28-890a-d87c6c53a74e	1
1734919	cyclophosphamide (as cyclophosphamide monohydrate) 1000 MG Injection	SY	1d3396d8-4c03-4a28-890a-d87c6c53a74e	1
1734921	cyclophosphamide (as cyclophosphamide monohydrate) 2000 MG Injection	SY	1d3396d8-4c03-4a28-890a-d87c6c53a74e	1
1734917	cyclophosphamide (as cyclophosphamide monohydrate) 500 MG Injection	SY	1d3396d8-4c03-4a28-890a-d87c6c53a74e	1
1734919	cyclophosphamide 1 GM Injection	SY	1d3396d8-4c03-4a28-890a-d87c6c53a74e	1
1734921	cyclophosphamide 2 GM Injection	SY	1d3396d8-4c03-4a28-890a-d87c6c53a74e	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
68001-696-32	68001069632	1 VIAL, SINGLE-DOSE in 1 CARTON (68001-696-32) / 100 mL in 1 VIAL, SINGLE-DOSE	2026-03-15	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Cyclophosphamide	BluePoint Laboratories \| Epic Pharma LLC	2026-03-12	HUMAN PRESCRIPTION DRUG LABEL	1