Cyclophosphamide

Product NDC: 42658-033
11-digit product format: 426580033
Labeler code: 42658
Product ID: 42658-033_5dec5de5-9f64-9f0a-e063-6294a90ace8d
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Cyclophosphamide for Injection
Dosage form: INJECTION, POWDER, FOR SOLUTION
Route: INTRAVENOUS
Labeler: Hisun Pharmaceuticals USA, Inc.
Application: ANDA218632
Marketing category: ANDA
Marketing start: 2026-10-16
Substance: CYCLOPHOSPHAMIDE
Active strength: 1 g/50mL
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 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A218632-001	CYCLOPHOSPHAMIDE	CYCLOPHOSPHAMIDE	500MG/VIAL	INJECTABLE / INJECTION	AP	2024-12-26
A218632-002	CYCLOPHOSPHAMIDE	CYCLOPHOSPHAMIDE	1GM/VIAL	INJECTABLE / INJECTION	AP	2024-12-26
A218632-003	CYCLOPHOSPHAMIDE	CYCLOPHOSPHAMIDE	2GM/VIAL	INJECTABLE / INJECTION	AP	2024-12-26

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A218632-001	AP
A218632-002	AP
A218632-003	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
2026-10-15 13:18:30	2026-09	A218632-001	CYCLOPHOSPHAMIDE	500MG/VIAL	INJECTABLE / INJECTION	AP	2024-12-26	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A218632-002	CYCLOPHOSPHAMIDE	1GM/VIAL	INJECTABLE / INJECTION	AP	2024-12-26	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A218632-003	CYCLOPHOSPHAMIDE	2GM/VIAL	INJECTABLE / INJECTION	AP	2024-12-26	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A218632-001	CYCLOPHOSPHAMIDE	500MG/VIAL	INJECTABLE / INJECTION	AP	2024-12-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A218632-002	CYCLOPHOSPHAMIDE	1GM/VIAL	INJECTABLE / INJECTION	AP	2024-12-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A218632-003	CYCLOPHOSPHAMIDE	2GM/VIAL	INJECTABLE / INJECTION	AP	2024-12-26	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A218632-001	CYCLOPHOSPHAMIDE	500MG/VIAL	INJECTABLE / INJECTION		2024-12-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A218632-002	CYCLOPHOSPHAMIDE	1GM/VIAL	INJECTABLE / INJECTION		2024-12-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A218632-003	CYCLOPHOSPHAMIDE	2GM/VIAL	INJECTABLE / INJECTION		2024-12-26	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A218632-001	CYCLOPHOSPHAMIDE	500MG/VIAL	INJECTABLE / INJECTION		2024-12-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A218632-002	CYCLOPHOSPHAMIDE	1GM/VIAL	INJECTABLE / INJECTION		2024-12-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A218632-003	CYCLOPHOSPHAMIDE	2GM/VIAL	INJECTABLE / INJECTION		2024-12-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A218632-001	CYCLOPHOSPHAMIDE	500MG/VIAL	INJECTABLE / INJECTION	AP	2024-12-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A218632-002	CYCLOPHOSPHAMIDE	1GM/VIAL	INJECTABLE / INJECTION	AP	2024-12-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A218632-003	CYCLOPHOSPHAMIDE	2GM/VIAL	INJECTABLE / INJECTION	AP	2024-12-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A218632-001	CYCLOPHOSPHAMIDE	500MG/VIAL	INJECTABLE / INJECTION	AP	2024-12-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A218632-002	CYCLOPHOSPHAMIDE	1GM/VIAL	INJECTABLE / INJECTION	AP	2024-12-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A218632-003	CYCLOPHOSPHAMIDE	2GM/VIAL	INJECTABLE / INJECTION	AP	2024-12-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A218632-001	CYCLOPHOSPHAMIDE	500MG/VIAL	INJECTABLE / INJECTION	AP	2024-12-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A218632-002	CYCLOPHOSPHAMIDE	1GM/VIAL	INJECTABLE / INJECTION	AP	2024-12-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A218632-003	CYCLOPHOSPHAMIDE	2GM/VIAL	INJECTABLE / INJECTION	AP	2024-12-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A218632-001	CYCLOPHOSPHAMIDE	500MG/VIAL	INJECTABLE / INJECTION	AP	2024-12-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A218632-002	CYCLOPHOSPHAMIDE	1GM/VIAL	INJECTABLE / INJECTION	AP	2024-12-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A218632-003	CYCLOPHOSPHAMIDE	2GM/VIAL	INJECTABLE / INJECTION	AP	2024-12-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A218632-001	CYCLOPHOSPHAMIDE	500MG/VIAL	INJECTABLE / INJECTION	AP	2024-12-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A218632-002	CYCLOPHOSPHAMIDE	1GM/VIAL	INJECTABLE / INJECTION	AP	2024-12-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A218632-003	CYCLOPHOSPHAMIDE	2GM/VIAL	INJECTABLE / INJECTION	AP	2024-12-26	`03ed91905a0d…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A218632-001	CYCLOPHOSPHAMIDE	500MG/VIAL	INJECTABLE / INJECTION		2024-12-26	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A218632-002	CYCLOPHOSPHAMIDE	1GM/VIAL	INJECTABLE / INJECTION		2024-12-26	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A218632-003	CYCLOPHOSPHAMIDE	2GM/VIAL	INJECTABLE / INJECTION		2024-12-26	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-10-15 13:18:30	2026-09	A218632-001	AP	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A218632-002	AP	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A218632-003	AP	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A218632-001	AP	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A218632-002	AP	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A218632-003	AP	1	`84e616aacf4f…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A218632-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A218632-002	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A218632-003	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A218632-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A218632-002	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A218632-003	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A218632-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A218632-002	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A218632-003	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A218632-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A218632-002	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A218632-003	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A218632-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A218632-002	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A218632-003	AP	1	`03ed91905a0d…`

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	1 g/50mL

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Cyclophosphamide	CYCLOPHOSPHAMIDE FOR INJECTION	Slate Run Pharmaceuticals, LLC	20bda486-cb9a-4d67-8c41-50e9fd066434	2025-04-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 218632 application number: ANDA218632
Cyclophosphamide	CYCLOPHOSPHAMIDE FOR INJECTION	Hainan Poly Pharm. Co., Ltd.	6fde2705-a2d8-4d48-9618-b9d99d051373	2025-01-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 218632 application number: ANDA218632

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
42658-033-01	42658003301	1 VIAL, SINGLE-DOSE in 1 CARTON (42658-033-01) / 50 mL in 1 VIAL, SINGLE-DOSE	2026-10-20	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Cyclophosphamide for Injection	Hisun Pharmaceuticals USA, Inc. \| Hainan Poly Pharm. Co., Ltd.	2026-10-15	HUMAN PRESCRIPTION DRUG LABEL	1