Home NDC 68001-564 CYCLOPHOSPHAMIDE
Product NDC 68001-564
11-digit product format 680010564
Labeler code 68001
Product ID 68001-564_3bc6345d-4340-1f0f-e063-6294a90ac0a9
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name cyclophosphamide
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler BluePoint Laboratories
Application NDA212501
Marketing category NDA
Marketing start 2023-04-10
Substance CYCLOPHOSPHAMIDE ANHYDROUS
Active strength 200 mg/mL
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes 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…
Additional Listing Data#
Finished product Yes
Brand name base CYCLOPHOSPHAMIDE
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CYCLOPHOSPHAMIDE ANHYDROUS 200 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 6UXW23996M Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2386859 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 68001-564-22 CYCLOPHOSPHAMIDE 1 in 1 CARTON INJECTION, SOLUTION 1 7 68001-564-22 CYCLOPHOSPHAMIDE 5 mL in 1 VIAL INJECTION, SOLUTION 5 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68001-564 CYCLOPHOSPHAMIDE INJECTION, SOLUTION [BLUEPOINT LABORATORIES] 6 Current NDC, 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 68001-564-22 68001056422 1 VIAL in 1 CARTON (68001-564-22) / 5 mL in 1 VIAL 1 vial 2023-04-10 0000-00-00 No No Current