Home NDC 14789-126-05 Cyclophosphamide
Product NDC 14789-126
Requested package NDC 14789-126-05
11-digit product format 147890126
Labeler code 14789
Product ID 14789-126_4e548b5c-d8d1-0f7a-e063-6294a90ae76e
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Cyclophosphamide
Dosage form INJECTION
Route INTRAVENOUS
Labeler Nexus Pharmaceuticals, LLC
Application ANDA216783
Marketing category ANDA
Marketing start 2026-03-30
Substance CYCLOPHOSPHAMIDE
Active strength 200 mg/mL
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A216783-001 CYCLOPHOSPHAMIDE CYCLOPHOSPHAMIDE 500MG/2.5ML (200MG/ML) SOLUTION / INTRAVENOUS AP 2024-10-29 A216783-002 CYCLOPHOSPHAMIDE CYCLOPHOSPHAMIDE 1GM/5ML (200MG/ML) SOLUTION / INTRAVENOUS AP 2024-10-29
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 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.
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 2026-02-19 14:30 UTC 2026-02 A216783-001 CYCLOPHOSPHAMIDE 500MG/2.5ML (200MG/ML) SOLUTION / INTRAVENOUS AP 2024-10-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A216783-002 CYCLOPHOSPHAMIDE 1GM/5ML (200MG/ML) SOLUTION / INTRAVENOUS AP 2024-10-29 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A216783-001 CYCLOPHOSPHAMIDE 500MG/2.5ML (200MG/ML) SOLUTION / INTRAVENOUS AP 2024-10-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A216783-002 CYCLOPHOSPHAMIDE 1GM/5ML (200MG/ML) SOLUTION / INTRAVENOUS AP 2024-10-29 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A216783-001 CYCLOPHOSPHAMIDE 500MG/2.5ML (200MG/ML) SOLUTION / INTRAVENOUS AP 2024-10-29 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A216783-002 CYCLOPHOSPHAMIDE 1GM/5ML (200MG/ML) SOLUTION / INTRAVENOUS AP 2024-10-29 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A216783-001 CYCLOPHOSPHAMIDE 500MG/2.5ML (200MG/ML) SOLUTION / INTRAVENOUS AP 2024-10-29 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A216783-002 CYCLOPHOSPHAMIDE 1GM/5ML (200MG/ML) SOLUTION / INTRAVENOUS AP 2024-10-29 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A216783-001 CYCLOPHOSPHAMIDE 500MG/2.5ML (200MG/ML) SOLUTION / INTRAVENOUS AP 2024-10-29 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A216783-002 CYCLOPHOSPHAMIDE 1GM/5ML (200MG/ML) SOLUTION / INTRAVENOUS AP 2024-10-29 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A216783-001 CYCLOPHOSPHAMIDE 500MG/2.5ML (200MG/ML) SOLUTION / INTRAVENOUS AP 2024-10-29 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A216783-002 CYCLOPHOSPHAMIDE 1GM/5ML (200MG/ML) SOLUTION / INTRAVENOUS AP 2024-10-29 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A216783-001 CYCLOPHOSPHAMIDE 500MG/2.5ML (200MG/ML) SOLUTION / INTRAVENOUS AP 2024-10-29 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A216783-002 CYCLOPHOSPHAMIDE 1GM/5ML (200MG/ML) SOLUTION / INTRAVENOUS AP 2024-10-29 2680178bc6a6…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A216783-001 CYCLOPHOSPHAMIDE 500MG/2.5ML (200MG/ML) SOLUTION / INTRAVENOUS AP 2024-10-29 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A216783-002 CYCLOPHOSPHAMIDE 1GM/5ML (200MG/ML) SOLUTION / INTRAVENOUS AP 2024-10-29 d8e5a09893c0…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A216783-001 CYCLOPHOSPHAMIDE 500MG/2.5ML (200MG/ML) SOLUTION / INTRAVENOUS AP 2024-10-29 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A216783-002 CYCLOPHOSPHAMIDE 1GM/5ML (200MG/ML) SOLUTION / INTRAVENOUS AP 2024-10-29 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Cyclophosphamide
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CYCLOPHOSPHAMIDE 200 mg/mL
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 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 14789-126-05 Cyclophosphamide 1 in 1 CARTON INJECTION 1 7 14789-126-07 Cyclophosphamide 5 mL in 1 VIAL, GLASS INJECTION 5 7
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 Sample Exclude flag Status 14789-126-05 14789012605 1 VIAL, GLASS in 1 CARTON (14789-126-05) / 5 mL in 1 VIAL, GLASS (14789-126-07) 2026-03-30 No No Current