Home NDC 0781-3529 Cyclophosphamide
Product NDC 0781-3529
11-digit product format 007813529
Labeler code 0781
Product ID 0781-3529_3a7a4ad7-90ca-4d84-92f1-c61032067deb
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Cyclophosphamide
Dosage form INJECTION, SOLUTION, CONCENTRATE
Route INTRAVENOUS
Labeler Sandoz Inc
Application NDA217150
Marketing category NDA
Marketing start 2024-04-08
Substance CYCLOPHOSPHAMIDE
Active strength 1000 mg/10mL
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 N217150-001 CYCLOPHOSPHAMIDE CYCLOPHOSPHAMIDE 500MG/5ML (100MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-09-12 N217150-002 CYCLOPHOSPHAMIDE CYCLOPHOSPHAMIDE 1GM/10ML (100MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-09-12 N217150-003 CYCLOPHOSPHAMIDE CYCLOPHOSPHAMIDE 2GM/20ML (100MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-09-12
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 2 · 63 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 N217150-001 CYCLOPHOSPHAMIDE 500MG/5ML (100MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-09-12 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N217150-002 CYCLOPHOSPHAMIDE 1GM/10ML (100MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-09-12 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N217150-003 CYCLOPHOSPHAMIDE 2GM/20ML (100MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-09-12 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N217150-001 CYCLOPHOSPHAMIDE 500MG/5ML (100MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-09-12 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N217150-002 CYCLOPHOSPHAMIDE 1GM/10ML (100MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-09-12 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N217150-003 CYCLOPHOSPHAMIDE 2GM/20ML (100MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-09-12 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N217150-001 CYCLOPHOSPHAMIDE 500MG/5ML (100MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-09-12 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N217150-002 CYCLOPHOSPHAMIDE 1GM/10ML (100MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-09-12 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N217150-003 CYCLOPHOSPHAMIDE 2GM/20ML (100MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-09-12 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N217150-001 CYCLOPHOSPHAMIDE 500MG/5ML (100MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-09-12 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N217150-002 CYCLOPHOSPHAMIDE 1GM/10ML (100MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-09-12 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N217150-003 CYCLOPHOSPHAMIDE 2GM/20ML (100MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-09-12 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N217150-001 CYCLOPHOSPHAMIDE 500MG/5ML (100MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-09-12 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N217150-002 CYCLOPHOSPHAMIDE 1GM/10ML (100MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-09-12 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N217150-003 CYCLOPHOSPHAMIDE 2GM/20ML (100MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-09-12 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N217150-001 CYCLOPHOSPHAMIDE 500MG/5ML (100MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-09-12 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N217150-002 CYCLOPHOSPHAMIDE 1GM/10ML (100MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-09-12 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N217150-003 CYCLOPHOSPHAMIDE 2GM/20ML (100MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-09-12 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N217150-001 CYCLOPHOSPHAMIDE 500MG/5ML (100MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-09-12 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N217150-002 CYCLOPHOSPHAMIDE 1GM/10ML (100MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-09-12 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N217150-003 CYCLOPHOSPHAMIDE 2GM/20ML (100MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-09-12 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N217150-001 CYCLOPHOSPHAMIDE 500MG/5ML (100MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-09-12 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N217150-002 CYCLOPHOSPHAMIDE 1GM/10ML (100MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-09-12 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N217150-003 CYCLOPHOSPHAMIDE 2GM/20ML (100MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-09-12 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N217150-001 CYCLOPHOSPHAMIDE 500MG/5ML (100MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-09-12 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N217150-002 CYCLOPHOSPHAMIDE 1GM/10ML (100MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-09-12 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N217150-003 CYCLOPHOSPHAMIDE 2GM/20ML (100MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-09-12 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N217150-001 CYCLOPHOSPHAMIDE 500MG/5ML (100MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-09-12 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N217150-002 CYCLOPHOSPHAMIDE 1GM/10ML (100MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-09-12 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N217150-003 CYCLOPHOSPHAMIDE 2GM/20ML (100MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-09-12 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N217150-001 CYCLOPHOSPHAMIDE 500MG/5ML (100MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-09-12 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N217150-002 CYCLOPHOSPHAMIDE 1GM/10ML (100MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-09-12 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N217150-003 CYCLOPHOSPHAMIDE 2GM/20ML (100MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-09-12 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N217150-001 CYCLOPHOSPHAMIDE 500MG/5ML (100MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-09-12 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N217150-002 CYCLOPHOSPHAMIDE 1GM/10ML (100MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-09-12 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N217150-003 CYCLOPHOSPHAMIDE 2GM/20ML (100MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-09-12 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N217150-001 CYCLOPHOSPHAMIDE 500MG/5ML (100MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-09-12 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N217150-002 CYCLOPHOSPHAMIDE 1GM/10ML (100MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-09-12 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N217150-003 CYCLOPHOSPHAMIDE 2GM/20ML (100MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-09-12 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N217150-001 CYCLOPHOSPHAMIDE 500MG/5ML (100MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-09-12 1e350fbaab3a…
Additional Listing Data#
Finished product Yes
Brand name base Cyclophosphamide
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CYCLOPHOSPHAMIDE 1000 mg/10mL
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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2679073 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 0781-3529-10 Cyclophosphamide 1 in 1 CARTON INJECTION, SOLUTION, CONCENTRATE 1 3 0781-3529-70 Cyclophosphamide 10 mL in 1 VIAL, MULTI-DOSE INJECTION, SOLUTION, CONCENTRATE 10 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0781-3529 CYCLOPHOSPHAMIDE INJECTION, SOLUTION, CONCENTRATE [SANDOZ INC] 3 Current NDC, 2 package rows 20250228_cf2f4b95-0327-499a-a5a3-51b1bdef68c5.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 Units Marketing start Sample Exclude flag Status 0781-3529-10 00781352910 1 VIAL, MULTI-DOSE in 1 CARTON (0781-3529-10) / 10 mL in 1 VIAL, MULTI-DOSE (0781-3529-70) 2024-04-08 No No Current 0781-3529-70 00781352970 10 mL in 1 VIAL, MULTI-DOSE 10 ml Historical