Cyclophosphamide

Product NDC: 70860-218
Requested package NDC: 70860-218-05
11-digit product format: 708600218
Labeler code: 70860
Product ID: 70860-218_7eaabaf5-ac12-406b-8432-8e01db8e519d
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: cyclophosphamide
Dosage form: INJECTION, SOLUTION
Route: INTRAVENOUS
Labeler: Athenex Pharmaceutical Division, LLC.
Application: NDA212501
Marketing category: NDA
Marketing start: 2020-12-11
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: 2022-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	70860-218	70860-218-05	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 · 10 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`

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…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
70860-218-03	2024-03-03	These highlights do not include all the information needed to use CYCLOPHOSPHAMIDE INJECTION safely and effectively. See full prescribing information for CYCLOPHOSPHAMIDE INJECTION. CYCLOPHOSPHAMIDE injection, for intravenous use Initial U.S. Approval: 1959
70860-218-05	2024-03-03	These highlights do not include all the information needed to use CYCLOPHOSPHAMIDE INJECTION safely and effectively. See full prescribing information for CYCLOPHOSPHAMIDE INJECTION. CYCLOPHOSPHAMIDE injection, for intravenous use Initial U.S. Approval: 1959
70860-218-10	2024-03-03	These highlights do not include all the information needed to use CYCLOPHOSPHAMIDE INJECTION safely and effectively. See full prescribing information for CYCLOPHOSPHAMIDE INJECTION. CYCLOPHOSPHAMIDE injection, for intravenous use Initial U.S. Approval: 1959
70860-218-03	2024-01-30	These highlights do not include all the information needed to use CYCLOPHOSPHAMIDE INJECTION safely and effectively. See full prescribing information for CYCLOPHOSPHAMIDE INJECTION. CYCLOPHOSPHAMIDE injection, for intravenous use Initial U.S. Approval: 1959
70860-218-05	2024-01-30	These highlights do not include all the information needed to use CYCLOPHOSPHAMIDE INJECTION safely and effectively. See full prescribing information for CYCLOPHOSPHAMIDE INJECTION. CYCLOPHOSPHAMIDE injection, for intravenous use Initial U.S. Approval: 1959
70860-218-10	2024-01-30	These highlights do not include all the information needed to use CYCLOPHOSPHAMIDE INJECTION safely and effectively. See full prescribing information for CYCLOPHOSPHAMIDE INJECTION. CYCLOPHOSPHAMIDE injection, for intravenous use Initial U.S. Approval: 1959

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
70860-218-03	ML - Milliliter	70860-218	5f6155f4-8e41-4897-9f3e-b99e104df0ac	1	2021-03-02
70860-218-05	ML - Milliliter	70860-218	afa1255a-c8f8-48cd-a866-a53d4d4572d2	1	2021-03-02
70860-218-10	ML - Milliliter	70860-218	39bcbc2c-6b19-466c-a42f-ad16114790a9	1	2022-01-06

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
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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
70860-218-05	70860021805	1 VIAL in 1 CARTON (70860-218-05) > 5 mL in 1 VIAL	1 vial	2020-12-11	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Cyclophosphamide	Athenex Pharmaceutical Division, LLC.	2024-03-03	HUMAN PRESCRIPTION DRUG LABEL	5