CYCLOPHOSPHAMIDE

Product NDC: 68001-563
11-digit product format: 680010563
Labeler code: 68001
Product ID: 68001-563_ee393ea3-02cb-a8d7-e053-2995a90a3963
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: cyclophosphamide
Dosage form: INJECTION, SOLUTION
Route: INTRAVENOUS
Labeler: BluePoint Laboratories
Application: NDA212501
Marketing category: NDA
Marketing start: 2022-11-30
Marketing end: 0000-00-00
Substance: CYCLOPHOSPHAMIDE ANHYDROUS
Active strength: 200 mg/mL
Pharmacologic classes: Alkylating Activity [MoA], Alkylating Drug [EPC]
NDC exclude flag: No
Listing certified through: 2023-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	68001-563		D	Discontinued by firm		2026-08-17
excluded package	package	68001-563	68001-563-84	D	Discontinued by firm		2026-08-17

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 18 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	68001-563-84	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	68001-563-84	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	68001-563-84	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	68001-563-84	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	68001-563-84	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	68001-563-84	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	68001-563-84	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	68001-563-84	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	68001-563-84	`0efc9e666f02…`	`f202fb6c5f17…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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	RLD / RS	Approval date
N212501-001	CYCLOPHOSPHAMIDE	CYCLOPHOSPHAMIDE	500MG/2.5ML (200MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2020-07-30
N212501-002	CYCLOPHOSPHAMIDE	CYCLOPHOSPHAMIDE	1GM/5ML (200MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2020-07-30
N212501-003	CYCLOPHOSPHAMIDE	CYCLOPHOSPHAMIDE	2GM/10ML (200MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2021-11-19

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N212501-001	AP
N212501-002	AP

Orange Book patents#

Current patent rows page 1 of 1 · 6 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Coverage / status	Submission date
N212501-001	10993952	2036-02-15	Drug product	2021-05-04
N212501-001	12329767	2036-02-15	Drug product	2025-07-17
N212501-002	10993952	2036-02-15	Drug product	2021-05-04
N212501-002	12329767	2036-02-15	Drug product	2025-07-17
N212501-003	10993952	2036-02-15	Drug product	2022-03-28
N212501-003	12329767	2036-02-15	Drug product	2025-07-17

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 3 · 110 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
2026-08-18 06:07:40	2026-07	N212501-001	CYCLOPHOSPHAMIDE	500MG/2.5ML (200MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2020-07-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N212501-002	CYCLOPHOSPHAMIDE	1GM/5ML (200MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2020-07-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N212501-003	CYCLOPHOSPHAMIDE	2GM/10ML (200MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2021-11-19	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N212501-001	CYCLOPHOSPHAMIDE	500MG/2.5ML (200MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2020-07-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212501-002	CYCLOPHOSPHAMIDE	1GM/5ML (200MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2020-07-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212501-003	CYCLOPHOSPHAMIDE	2GM/10ML (200MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2021-11-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212501-001	CYCLOPHOSPHAMIDE	500MG/2.5ML (200MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2020-07-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212501-002	CYCLOPHOSPHAMIDE	1GM/5ML (200MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2020-07-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212501-003	CYCLOPHOSPHAMIDE	2GM/10ML (200MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2021-11-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N212501-001	CYCLOPHOSPHAMIDE	500MG/2.5ML (200MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2020-07-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N212501-002	CYCLOPHOSPHAMIDE	1GM/5ML (200MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2020-07-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N212501-003	CYCLOPHOSPHAMIDE	2GM/10ML (200MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2021-11-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N212501-001	CYCLOPHOSPHAMIDE	500MG/2.5ML (200MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2020-07-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N212501-002	CYCLOPHOSPHAMIDE	1GM/5ML (200MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2020-07-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N212501-003	CYCLOPHOSPHAMIDE	2GM/10ML (200MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2021-11-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N212501-001	CYCLOPHOSPHAMIDE	500MG/2.5ML (200MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2020-07-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N212501-002	CYCLOPHOSPHAMIDE	1GM/5ML (200MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2020-07-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N212501-003	CYCLOPHOSPHAMIDE	2GM/10ML (200MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2021-11-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N212501-001	CYCLOPHOSPHAMIDE	500MG/2.5ML (200MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2020-07-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N212501-002	CYCLOPHOSPHAMIDE	1GM/5ML (200MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2020-07-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N212501-003	CYCLOPHOSPHAMIDE	2GM/10ML (200MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2021-11-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N212501-001	CYCLOPHOSPHAMIDE	500MG/2.5ML (200MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2020-07-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N212501-002	CYCLOPHOSPHAMIDE	1GM/5ML (200MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2020-07-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N212501-003	CYCLOPHOSPHAMIDE	2GM/10ML (200MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2021-11-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N212501-001	CYCLOPHOSPHAMIDE	500MG/2.5ML (200MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2020-07-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N212501-002	CYCLOPHOSPHAMIDE	1GM/5ML (200MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2020-07-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N212501-003	CYCLOPHOSPHAMIDE	2GM/10ML (200MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2021-11-19	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N212501-001	CYCLOPHOSPHAMIDE	500MG/2.5ML (200MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2020-07-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N212501-002	CYCLOPHOSPHAMIDE	1GM/5ML (200MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2020-07-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N212501-003	CYCLOPHOSPHAMIDE	2GM/10ML (200MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2021-11-19	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N212501-001	CYCLOPHOSPHAMIDE	500MG/2.5ML (200MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2020-07-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N212501-002	CYCLOPHOSPHAMIDE	1GM/5ML (200MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2020-07-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N212501-003	CYCLOPHOSPHAMIDE	2GM/10ML (200MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2021-11-19	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N212501-001	CYCLOPHOSPHAMIDE	500MG/2.5ML (200MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2020-07-30	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N212501-002	CYCLOPHOSPHAMIDE	1GM/5ML (200MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2020-07-30	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N212501-003	CYCLOPHOSPHAMIDE	2GM/10ML (200MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2021-11-19	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N212501-001	CYCLOPHOSPHAMIDE	500MG/2.5ML (200MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2020-07-30	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N212501-002	CYCLOPHOSPHAMIDE	1GM/5ML (200MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2020-07-30	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N212501-003	CYCLOPHOSPHAMIDE	2GM/10ML (200MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2021-11-19	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N212501-001	CYCLOPHOSPHAMIDE	500MG/2.5ML (200MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2020-07-30	`1e350fbaab3a…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	N212501-001	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N212501-002	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N212501-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212501-002	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212501-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212501-002	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N212501-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N212501-002	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N212501-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N212501-002	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N212501-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N212501-002	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N212501-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N212501-002	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N212501-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N212501-002	AP	1	`2680178bc6a6…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N212501-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N212501-002	AP	1	`d8e5a09893c0…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N212501-001	AP	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N212501-002	AP	1	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 3 · 114 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Coverage / status	Submission date	Source SHA-256
2026-08-18 06:07:40	2026-07	N212501-001	10993952	2036-02-15	Drug product	2021-05-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N212501-001	12329767	2036-02-15	Drug product	2025-07-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N212501-002	10993952	2036-02-15	Drug product	2021-05-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N212501-002	12329767	2036-02-15	Drug product	2025-07-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N212501-003	10993952	2036-02-15	Drug product	2022-03-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N212501-003	12329767	2036-02-15	Drug product	2025-07-17	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N212501-001	10993952	2036-02-15	Drug product	2021-05-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212501-001	12329767	2036-02-15	Drug product	2025-07-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212501-002	10993952	2036-02-15	Drug product	2021-05-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212501-002	12329767	2036-02-15	Drug product	2025-07-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212501-003	10993952	2036-02-15	Drug product	2022-03-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212501-003	12329767	2036-02-15	Drug product	2025-07-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212501-001	10993952	2036-02-15	Drug product	2021-05-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212501-001	12329767	2036-02-15	Drug product	2025-07-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212501-002	10993952	2036-02-15	Drug product	2021-05-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212501-002	12329767	2036-02-15	Drug product	2025-07-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212501-003	10993952	2036-02-15	Drug product	2022-03-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212501-003	12329767	2036-02-15	Drug product	2025-07-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N212501-001	10993952	2036-02-15	Drug product	2021-05-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N212501-001	12329767	2036-02-15	Drug product	2025-07-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N212501-002	10993952	2036-02-15	Drug product	2021-05-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N212501-002	12329767	2036-02-15	Drug product	2025-07-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N212501-003	10993952	2036-02-15	Drug product	2022-03-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N212501-003	12329767	2036-02-15	Drug product	2025-07-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N212501-001	10993952	2036-02-15	Drug product	2021-05-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N212501-002	10993952	2036-02-15	Drug product	2021-05-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N212501-003	10993952	2036-02-15	Drug product	2022-03-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N212501-001	10993952	2036-02-15	Drug product	2021-05-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N212501-002	10993952	2036-02-15	Drug product	2021-05-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N212501-003	10993952	2036-02-15	Drug product	2022-03-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N212501-001	10993952	2036-02-15	Drug product	2021-05-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N212501-002	10993952	2036-02-15	Drug product	2021-05-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N212501-003	10993952	2036-02-15	Drug product	2022-03-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N212501-001	10993952	2036-02-15	Drug product	2021-05-04	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N212501-002	10993952	2036-02-15	Drug product	2021-05-04	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N212501-003	10993952	2036-02-15	Drug product	2022-03-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N212501-001	10993952	2036-02-15	Drug product	2021-05-04	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N212501-002	10993952	2036-02-15	Drug product	2021-05-04	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N212501-003	10993952	2036-02-15	Drug product	2022-03-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N212501-001	10993952	2036-02-15	Drug product	2021-05-04	`d8e5a09893c0…`

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
7792dadb-52b6-46b6-8fdf-80b1171065b5	Product name	1	20180810

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68001-563-84	CYCLOPHOSPHAMIDE	2.5 mL in 1 VIAL	INJECTION, SOLUTION	2.5		7
68001-563-84	CYCLOPHOSPHAMIDE	1 in 1 CARTON	INJECTION, SOLUTION	1		7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68001-563	CYCLOPHOSPHAMIDE INJECTION, SOLUTION [BLUEPOINT LABORATORIES]	6	Legacy NDC, 2 package rows	20241122_0afd2cc7-09e6-481a-afea-9d2e3742da46.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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
CYCLOPHOSPHAMIDE	CYCLOPHOSPHAMIDE	BluePoint Laboratories	0afd2cc7-09e6-481a-afea-9d2e3742da46	2025-08-07	Warnings, Adverse reactions	Exact identifier application applno (NDA): 212501 application number: NDA212501 ndc (product): 68001-563
CYCLOPHOSPHAMIDE	CYCLOPHOSPHAMIDE	Dr. Reddy's Labratories Inc.	a5818647-d840-e9d7-c7b8-6541b485e44e	2025-03-11	Warnings, Adverse reactions	Exact identifier application applno (NDA): 212501 application number: NDA212501

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
6UXW23996M	CYCLOPHOSPHAMIDE ANHYDROUS	50-18-0	CYCLOPHOSPHAMIDE ANHYDROUS
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	0afd2cc7-09e6-481a-afea-9d2e3742da46	7
2386859	cyclophosphamide 200 MG/ML Injectable Solution	SCD	0afd2cc7-09e6-481a-afea-9d2e3742da46	7

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68001-563-84	68001056384	1 VIAL in 1 CARTON (68001-563-84) > 2.5 mL in 1 VIAL	1 vial	2022-11-30	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
CYCLOPHOSPHAMIDE	BluePoint Laboratories \| Ingenus Pharmaceuticals GmbH	2025-08-07	HUMAN PRESCRIPTION DRUG LABEL	7