Home NDC 55150-270 Cyclophosphamide
Product NDC 55150-270
11-digit product format 551500270
Labeler code 55150
Product ID 55150-270_f90b3bb0-87cd-4951-9789-34202e2b13df
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Cyclophosphamide
Dosage form INJECTION
Route INTRAVENOUS
Labeler Eugia US LLC
Application NDA210735
Marketing category NDA
Marketing start 2021-08-25
Substance CYCLOPHOSPHAMIDE
Active strength 500 mg/2.5mL
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes 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 · 11 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…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…
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 N210735-001 CYCLOPHOSPHAMIDE CYCLOPHOSPHAMIDE 500MG/2.5ML (200MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2021-08-25 N210735-002 CYCLOPHOSPHAMIDE CYCLOPHOSPHAMIDE 1GM/5ML (200MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2021-08-25 N210735-003 CYCLOPHOSPHAMIDE CYCLOPHOSPHAMIDE 2GM/10ML (200MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-11-20
Orange Book patents# Current patent rows page 1 of 1 · 3 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N210735-001 9662342 2035-06-26 Drug product 2021-09-03 N210735-002 9662342 2035-06-26 Drug product 2021-09-03 N210735-003 9662342 2035-06-26 Drug product 2023-11-29
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 · 87 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 N210735-001 CYCLOPHOSPHAMIDE 500MG/2.5ML (200MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2021-08-25 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N210735-002 CYCLOPHOSPHAMIDE 1GM/5ML (200MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2021-08-25 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N210735-003 CYCLOPHOSPHAMIDE 2GM/10ML (200MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-11-20 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N210735-001 CYCLOPHOSPHAMIDE 500MG/2.5ML (200MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2021-08-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210735-002 CYCLOPHOSPHAMIDE 1GM/5ML (200MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2021-08-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210735-003 CYCLOPHOSPHAMIDE 2GM/10ML (200MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-11-20 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210735-001 CYCLOPHOSPHAMIDE 500MG/2.5ML (200MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2021-08-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210735-002 CYCLOPHOSPHAMIDE 1GM/5ML (200MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2021-08-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210735-003 CYCLOPHOSPHAMIDE 2GM/10ML (200MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-11-20 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N210735-001 CYCLOPHOSPHAMIDE 500MG/2.5ML (200MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2021-08-25 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N210735-002 CYCLOPHOSPHAMIDE 1GM/5ML (200MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2021-08-25 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N210735-003 CYCLOPHOSPHAMIDE 2GM/10ML (200MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-11-20 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N210735-001 CYCLOPHOSPHAMIDE 500MG/2.5ML (200MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2021-08-25 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N210735-002 CYCLOPHOSPHAMIDE 1GM/5ML (200MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2021-08-25 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N210735-003 CYCLOPHOSPHAMIDE 2GM/10ML (200MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-11-20 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N210735-001 CYCLOPHOSPHAMIDE 500MG/2.5ML (200MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2021-08-25 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N210735-002 CYCLOPHOSPHAMIDE 1GM/5ML (200MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2021-08-25 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N210735-003 CYCLOPHOSPHAMIDE 2GM/10ML (200MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-11-20 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N210735-001 CYCLOPHOSPHAMIDE 500MG/2.5ML (200MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2021-08-25 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N210735-002 CYCLOPHOSPHAMIDE 1GM/5ML (200MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2021-08-25 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N210735-003 CYCLOPHOSPHAMIDE 2GM/10ML (200MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-11-20 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N210735-001 CYCLOPHOSPHAMIDE 500MG/2.5ML (200MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2021-08-25 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N210735-002 CYCLOPHOSPHAMIDE 1GM/5ML (200MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2021-08-25 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N210735-003 CYCLOPHOSPHAMIDE 2GM/10ML (200MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-11-20 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N210735-001 CYCLOPHOSPHAMIDE 500MG/2.5ML (200MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2021-08-25 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N210735-002 CYCLOPHOSPHAMIDE 1GM/5ML (200MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2021-08-25 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N210735-003 CYCLOPHOSPHAMIDE 2GM/10ML (200MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-11-20 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N210735-001 CYCLOPHOSPHAMIDE 500MG/2.5ML (200MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2021-08-25 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N210735-002 CYCLOPHOSPHAMIDE 1GM/5ML (200MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2021-08-25 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N210735-003 CYCLOPHOSPHAMIDE 2GM/10ML (200MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-11-20 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N210735-001 CYCLOPHOSPHAMIDE 500MG/2.5ML (200MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2021-08-25 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N210735-002 CYCLOPHOSPHAMIDE 1GM/5ML (200MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2021-08-25 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N210735-003 CYCLOPHOSPHAMIDE 2GM/10ML (200MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-11-20 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N210735-001 CYCLOPHOSPHAMIDE 500MG/2.5ML (200MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2021-08-25 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N210735-002 CYCLOPHOSPHAMIDE 1GM/5ML (200MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2021-08-25 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N210735-003 CYCLOPHOSPHAMIDE 2GM/10ML (200MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-11-20 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N210735-001 CYCLOPHOSPHAMIDE 500MG/2.5ML (200MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2021-08-25 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N210735-002 CYCLOPHOSPHAMIDE 1GM/5ML (200MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2021-08-25 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N210735-003 CYCLOPHOSPHAMIDE 2GM/10ML (200MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-11-20 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N210735-001 CYCLOPHOSPHAMIDE 500MG/2.5ML (200MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2021-08-25 1e350fbaab3a…
Observed Orange Book patent history# Patent history page 1 of 3 · 87 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 N210735-001 9662342 2035-06-26 Drug product 2021-09-03 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N210735-002 9662342 2035-06-26 Drug product 2021-09-03 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N210735-003 9662342 2035-06-26 Drug product 2023-11-29 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N210735-001 9662342 2035-06-26 Drug product 2021-09-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210735-002 9662342 2035-06-26 Drug product 2021-09-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210735-003 9662342 2035-06-26 Drug product 2023-11-29 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210735-001 9662342 2035-06-26 Drug product 2021-09-03 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210735-002 9662342 2035-06-26 Drug product 2021-09-03 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210735-003 9662342 2035-06-26 Drug product 2023-11-29 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N210735-001 9662342 2035-06-26 Drug product 2021-09-03 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N210735-002 9662342 2035-06-26 Drug product 2021-09-03 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N210735-003 9662342 2035-06-26 Drug product 2023-11-29 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N210735-001 9662342 2035-06-26 Drug product 2021-09-03 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N210735-002 9662342 2035-06-26 Drug product 2021-09-03 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N210735-003 9662342 2035-06-26 Drug product 2023-11-29 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N210735-001 9662342 2035-06-26 Drug product 2021-09-03 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N210735-002 9662342 2035-06-26 Drug product 2021-09-03 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N210735-003 9662342 2035-06-26 Drug product 2023-11-29 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N210735-001 9662342 2035-06-26 Drug product 2021-09-03 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N210735-002 9662342 2035-06-26 Drug product 2021-09-03 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N210735-003 9662342 2035-06-26 Drug product 2023-11-29 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N210735-001 9662342 2035-06-26 Drug product 2021-09-03 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N210735-002 9662342 2035-06-26 Drug product 2021-09-03 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N210735-003 9662342 2035-06-26 Drug product 2023-11-29 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N210735-001 9662342 2035-06-26 Drug product 2021-09-03 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N210735-002 9662342 2035-06-26 Drug product 2021-09-03 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N210735-003 9662342 2035-06-26 Drug product 2023-11-29 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N210735-001 9662342 2035-06-26 Drug product 2021-09-03 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N210735-002 9662342 2035-06-26 Drug product 2021-09-03 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N210735-003 9662342 2035-06-26 Drug product 2023-11-29 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N210735-001 9662342 2035-06-26 Drug product 2021-09-03 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N210735-002 9662342 2035-06-26 Drug product 2021-09-03 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N210735-003 9662342 2035-06-26 Drug product 2023-11-29 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N210735-001 9662342 2035-06-26 Drug product 2021-09-03 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N210735-002 9662342 2035-06-26 Drug product 2021-09-03 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N210735-003 9662342 2035-06-26 Drug product 2023-11-29 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N210735-001 9662342 2035-06-26 Drug product 2021-09-03 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N210735-002 9662342 2035-06-26 Drug product 2021-09-03 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N210735-003 9662342 2035-06-26 Drug product 2023-11-29 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N210735-001 9662342 2035-06-26 Drug product 2021-09-03 1e350fbaab3a…
Additional Listing Data#
Finished product Yes
Brand name base Cyclophosphamide
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CYCLOPHOSPHAMIDE 500 mg/2.5mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 8N3DW7272P Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2386859 Internal RxNorm lookup 2568661 Internal RxNorm lookup 2568663 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 55150-270-01 Cyclophosphamide 2.5 mL in 1 VIAL, SINGLE-DOSE INJECTION 2.5 5 55150-270-01 Cyclophosphamide 01 in 1 CARTON INJECTION 01 5 55150-270-99 Cyclophosphamide 1 in 1 CARTON INJECTION 1 5 55150-270-99 Cyclophosphamide 2.5 mL in 1 VIAL, MULTI-DOSE INJECTION 2.5 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 55150-270 CYCLOPHOSPHAMIDE INJECTION [EUGIA US LLC] 5 Current NDC, Legacy NDC, 4 package rows 20250425_3c1eb470-0bba-457d-94e3-b9508f0d398a.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 · 1 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 55150-270-01 55150027001 1 VIAL, SINGLE-DOSE in 1 CARTON (55150-270-01) > 2.5 mL in 1 VIAL, SINGLE-DOSE 2021-08-25 0000-00-00 No No Current 55150-270-99 55150027099 1 VIAL, MULTI-DOSE in 1 CARTON (55150-270-99) / 2.5 mL in 1 VIAL, MULTI-DOSE 2023-11-20 No No Current