Home NDC 68001-563-84 CYCLOPHOSPHAMIDE
Product NDC 68001-563
Requested package NDC 68001-563-84
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 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 · 9 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…
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.
Orange Book patents# Current patent rows page 1 of 1 · 6 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code 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# 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 Use code 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# 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.
DailyMed RxNorm Mappings# 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