Cyclophosphamide

Product NDC: 70301-2015
Requested package NDC: 70301-2015-1
11-digit product format: 703012015
Labeler code: 70301
Product ID: 70301-2015_5c9236e9-5c1e-72f8-e063-6394a90a3e58
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: CYCLOPHOSPHAMIDE
Dosage form: CAPSULE
Route: ORAL
Labeler: OPKO Pharmaceuticals, LLC
Application: ANDA218282
Marketing category: ANDA
Marketing start: 2026-09-16
Substance: CYCLOPHOSPHAMIDE
Active strength: 50 mg/1
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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A218282-001	CYCLOPHOSPHAMIDE	CYCLOPHOSPHAMIDE	25MG	CAPSULE / ORAL	AB		2024-12-03
A218282-002	CYCLOPHOSPHAMIDE	CYCLOPHOSPHAMIDE	50MG	CAPSULE / ORAL	AB		2024-12-03

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A218282-001	AB
A218282-002	AB

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	A218282-001	CYCLOPHOSPHAMIDE	25MG	CAPSULE / ORAL	AB	2024-12-03	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A218282-002	CYCLOPHOSPHAMIDE	50MG	CAPSULE / ORAL	AB	2024-12-03	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A218282-001	CYCLOPHOSPHAMIDE	25MG	CAPSULE / ORAL	AB	2024-12-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A218282-002	CYCLOPHOSPHAMIDE	50MG	CAPSULE / ORAL	AB	2024-12-03	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A218282-001	CYCLOPHOSPHAMIDE	25MG	CAPSULE / ORAL	AB	2024-12-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A218282-002	CYCLOPHOSPHAMIDE	50MG	CAPSULE / ORAL	AB	2024-12-03	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A218282-001	CYCLOPHOSPHAMIDE	25MG	CAPSULE / ORAL	AB	2024-12-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A218282-002	CYCLOPHOSPHAMIDE	50MG	CAPSULE / ORAL	AB	2024-12-03	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A218282-001	CYCLOPHOSPHAMIDE	25MG	CAPSULE / ORAL	AB	2024-12-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A218282-002	CYCLOPHOSPHAMIDE	50MG	CAPSULE / ORAL	AB	2024-12-03	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A218282-001	CYCLOPHOSPHAMIDE	25MG	CAPSULE / ORAL	AB	2024-12-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A218282-002	CYCLOPHOSPHAMIDE	50MG	CAPSULE / ORAL	AB	2024-12-03	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A218282-001	CYCLOPHOSPHAMIDE	25MG	CAPSULE / ORAL	AB	2024-12-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A218282-002	CYCLOPHOSPHAMIDE	50MG	CAPSULE / ORAL	AB	2024-12-03	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A218282-001	CYCLOPHOSPHAMIDE	25MG	CAPSULE / ORAL	AB	2024-12-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A218282-002	CYCLOPHOSPHAMIDE	50MG	CAPSULE / ORAL	AB	2024-12-03	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A218282-001	CYCLOPHOSPHAMIDE	25MG	CAPSULE / ORAL	AB	2024-12-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A218282-002	CYCLOPHOSPHAMIDE	50MG	CAPSULE / ORAL	AB	2024-12-03	`2680178bc6a6…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A218282-001	CYCLOPHOSPHAMIDE	25MG	CAPSULE / ORAL	AB	2024-12-03	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A218282-002	CYCLOPHOSPHAMIDE	50MG	CAPSULE / ORAL	AB	2024-12-03	`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	A218282-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A218282-002	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A218282-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A218282-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A218282-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A218282-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A218282-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A218282-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A218282-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A218282-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A218282-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A218282-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A218282-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A218282-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A218282-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A218282-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A218282-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A218282-002	AB	1	`2680178bc6a6…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A218282-001	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A218282-002	AB	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	50 mg/1

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
70301-2015-1	Cyclophosphamide	100 in 1 BOTTLE	CAPSULE	100		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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Cyclophosphamide	CYCLOPHOSPHAMIDE	OPKO Pharmaceuticals, LLC	d8057d1a-e8af-42ab-9da2-b545730b2655	2026-05-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 218282 application number: ANDA218282
Cyclophosphamide	CYCLOPHOSPHAMIDE	OPKO Pharmaceuticals, LLC	7d6447e3-22c9-48d9-87c0-d0b576d7ea9e	2026-04-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 218282 application number: ANDA218282 ndc (package): 70301-2015-1 ndc (product): 70301-2015 ndc11 (package): 70301201501

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
1437969	cycloPHOSphamide 50 MG Oral Capsule	PSN	7d6447e3-22c9-48d9-87c0-d0b576d7ea9e	1
1437969	cyclophosphamide 50 MG Oral Capsule	SCD	7d6447e3-22c9-48d9-87c0-d0b576d7ea9e	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
70301-2015-1	70301201501	100 CAPSULE in 1 BOTTLE (70301-2015-1)	100 capsule	2026-09-16	No	No	Current