Home NDC 65219-133 Cyclophosphamide
Product NDC 65219-133
11-digit product format 652190133
Labeler code 65219
Product ID 65219-133_fadfc813-11a5-415a-9d70-06c579e7619c
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name cyclophosphamide
Dosage form INJECTION, POWDER, FOR SOLUTION
Route INTRAVENOUS; ORAL
Labeler Fresenius Kabi USA, LLC
Application ANDA204555
Marketing category ANDA
Marketing start 2023-11-17
Substance CYCLOPHOSPHAMIDE
Active strength 2 g/100mL
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 A204555-001 CYCLOPHOSPHAMIDE CYCLOPHOSPHAMIDE 500MG/VIAL INJECTABLE / INJECTION AP 2014-10-31 A204555-002 CYCLOPHOSPHAMIDE CYCLOPHOSPHAMIDE 1GM/VIAL INJECTABLE / INJECTION AP 2014-10-31 A204555-003 CYCLOPHOSPHAMIDE CYCLOPHOSPHAMIDE 2GM/VIAL INJECTABLE / INJECTION AP 2014-10-31
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 matching rows.
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 4 · 126 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 A204555-001 CYCLOPHOSPHAMIDE 500MG/VIAL INJECTABLE / INJECTION AP 2014-10-31 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A204555-002 CYCLOPHOSPHAMIDE 1GM/VIAL INJECTABLE / INJECTION AP 2014-10-31 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A204555-003 CYCLOPHOSPHAMIDE 2GM/VIAL INJECTABLE / INJECTION AP 2014-10-31 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A204555-001 CYCLOPHOSPHAMIDE 500MG/VIAL INJECTABLE / INJECTION AP 2014-10-31 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A204555-002 CYCLOPHOSPHAMIDE 1GM/VIAL INJECTABLE / INJECTION AP 2014-10-31 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A204555-003 CYCLOPHOSPHAMIDE 2GM/VIAL INJECTABLE / INJECTION AP 2014-10-31 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A204555-001 CYCLOPHOSPHAMIDE 500MG/VIAL INJECTABLE / INJECTION AP 2014-10-31 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A204555-002 CYCLOPHOSPHAMIDE 1GM/VIAL INJECTABLE / INJECTION AP 2014-10-31 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A204555-003 CYCLOPHOSPHAMIDE 2GM/VIAL INJECTABLE / INJECTION AP 2014-10-31 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A204555-001 CYCLOPHOSPHAMIDE 500MG/VIAL INJECTABLE / INJECTION AP 2014-10-31 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A204555-002 CYCLOPHOSPHAMIDE 1GM/VIAL INJECTABLE / INJECTION AP 2014-10-31 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A204555-003 CYCLOPHOSPHAMIDE 2GM/VIAL INJECTABLE / INJECTION AP 2014-10-31 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A204555-001 CYCLOPHOSPHAMIDE 500MG/VIAL INJECTABLE / INJECTION AP 2014-10-31 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A204555-002 CYCLOPHOSPHAMIDE 1GM/VIAL INJECTABLE / INJECTION AP 2014-10-31 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A204555-003 CYCLOPHOSPHAMIDE 2GM/VIAL INJECTABLE / INJECTION AP 2014-10-31 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A204555-001 CYCLOPHOSPHAMIDE 500MG/VIAL INJECTABLE / INJECTION AP 2014-10-31 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A204555-002 CYCLOPHOSPHAMIDE 1GM/VIAL INJECTABLE / INJECTION AP 2014-10-31 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A204555-003 CYCLOPHOSPHAMIDE 2GM/VIAL INJECTABLE / INJECTION AP 2014-10-31 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A204555-001 CYCLOPHOSPHAMIDE 500MG/VIAL INJECTABLE / INJECTION AP 2014-10-31 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A204555-002 CYCLOPHOSPHAMIDE 1GM/VIAL INJECTABLE / INJECTION AP 2014-10-31 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A204555-003 CYCLOPHOSPHAMIDE 2GM/VIAL INJECTABLE / INJECTION AP 2014-10-31 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A204555-001 CYCLOPHOSPHAMIDE 500MG/VIAL INJECTABLE / INJECTION AP 2014-10-31 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A204555-002 CYCLOPHOSPHAMIDE 1GM/VIAL INJECTABLE / INJECTION AP 2014-10-31 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A204555-003 CYCLOPHOSPHAMIDE 2GM/VIAL INJECTABLE / INJECTION AP 2014-10-31 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A204555-001 CYCLOPHOSPHAMIDE 500MG/VIAL INJECTABLE / INJECTION AP 2014-10-31 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A204555-002 CYCLOPHOSPHAMIDE 1GM/VIAL INJECTABLE / INJECTION AP 2014-10-31 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A204555-003 CYCLOPHOSPHAMIDE 2GM/VIAL INJECTABLE / INJECTION AP 2014-10-31 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A204555-001 CYCLOPHOSPHAMIDE 500MG/VIAL INJECTABLE / INJECTION AP 2014-10-31 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A204555-002 CYCLOPHOSPHAMIDE 1GM/VIAL INJECTABLE / INJECTION AP 2014-10-31 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A204555-003 CYCLOPHOSPHAMIDE 2GM/VIAL INJECTABLE / INJECTION AP 2014-10-31 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A204555-001 CYCLOPHOSPHAMIDE 500MG/VIAL INJECTABLE / INJECTION AP 2014-10-31 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A204555-002 CYCLOPHOSPHAMIDE 1GM/VIAL INJECTABLE / INJECTION AP 2014-10-31 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A204555-003 CYCLOPHOSPHAMIDE 2GM/VIAL INJECTABLE / INJECTION AP 2014-10-31 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A204555-001 CYCLOPHOSPHAMIDE 500MG/VIAL INJECTABLE / INJECTION AP 2014-10-31 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A204555-002 CYCLOPHOSPHAMIDE 1GM/VIAL INJECTABLE / INJECTION AP 2014-10-31 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A204555-003 CYCLOPHOSPHAMIDE 2GM/VIAL INJECTABLE / INJECTION AP 2014-10-31 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A204555-001 CYCLOPHOSPHAMIDE 500MG/VIAL INJECTABLE / INJECTION AP 2014-10-31 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A204555-002 CYCLOPHOSPHAMIDE 1GM/VIAL INJECTABLE / INJECTION AP 2014-10-31 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A204555-003 CYCLOPHOSPHAMIDE 2GM/VIAL INJECTABLE / INJECTION AP 2014-10-31 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A204555-001 CYCLOPHOSPHAMIDE 500MG/VIAL INJECTABLE / INJECTION AP 2014-10-31 1e350fbaab3a…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 126 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Cyclophosphamide
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CYCLOPHOSPHAMIDE 2 g/100mL
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 1734917 Internal RxNorm lookup 1734919 Internal RxNorm lookup 1734921 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 65219-133-20 Cyclophosphamide 100 mL in 1 VIAL, SINGLE-DOSE INJECTION, POWDER, FOR SOLUTION 100 2 65219-133-20 Cyclophosphamide 1 in 1 CARTON INJECTION, POWDER, FOR SOLUTION 1 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 65219-133 CYCLOPHOSPHAMIDE INJECTION, POWDER, FOR SOLUTION [FRESENIUS KABI USA, LLC] 2 Current NDC, 2 package rows 20241022_31986d36-a1bf-4903-93a4-ce7386241ba1.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 · 3 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 65219-133-20 65219013320 1 VIAL, SINGLE-DOSE in 1 CARTON (65219-133-20) / 100 mL in 1 VIAL, SINGLE-DOSE 2023-11-17 No No Current