Home NDC 70301-2013 Cyclophosphamide
Product NDC 70301-2013
11-digit product format 703012013
Labeler code 70301
Product ID 70301-2013_5c922933-a668-9f4b-e063-6294a90ae37f
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name CYCLOPHOSPHAMIDE
Dosage form CAPSULE
Route ORAL
Labeler OPKO Pharmaceuticals, LLC
Application ANDA218282
Marketing category ANDA
Marketing start 2026-09-16
Substance CYCLOPHOSPHAMIDE
Active strength 25 mg/1
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 44 .
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 A218282-001 CYCLOPHOSPHAMIDE CYCLOPHOSPHAMIDE 25MG CAPSULE / ORAL AB 2024-12-03 A218282-002 CYCLOPHOSPHAMIDE CYCLOPHOSPHAMIDE 50MG CAPSULE / ORAL AB 2024-12-03
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 2026-10-15 13:18:30 2026-09 A218282-001 CYCLOPHOSPHAMIDE 25MG CAPSULE / ORAL AB 2024-12-03 c2088c7a36db…2026-10-15 13:18:30 2026-09 A218282-002 CYCLOPHOSPHAMIDE 50MG CAPSULE / ORAL AB 2024-12-03 c2088c7a36db…2026-09-14 22:38:34 2026-08 A218282-001 CYCLOPHOSPHAMIDE 25MG CAPSULE / ORAL AB 2024-12-03 84e616aacf4f…2026-09-14 22:38:34 2026-08 A218282-002 CYCLOPHOSPHAMIDE 50MG CAPSULE / ORAL AB 2024-12-03 84e616aacf4f…2026-08-18 06:07:40 2026-07 A218282-001 CYCLOPHOSPHAMIDE 25MG CAPSULE / ORAL AB 2024-12-03 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A218282-002 CYCLOPHOSPHAMIDE 50MG CAPSULE / ORAL AB 2024-12-03 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A218282-001 CYCLOPHOSPHAMIDE 25MG CAPSULE / ORAL AB 2024-12-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A218282-002 CYCLOPHOSPHAMIDE 50MG CAPSULE / ORAL AB 2024-12-03 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A218282-001 CYCLOPHOSPHAMIDE 25MG CAPSULE / ORAL AB 2024-12-03 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A218282-002 CYCLOPHOSPHAMIDE 50MG CAPSULE / ORAL AB 2024-12-03 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A218282-001 CYCLOPHOSPHAMIDE 25MG CAPSULE / ORAL AB 2024-12-03 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A218282-002 CYCLOPHOSPHAMIDE 50MG CAPSULE / ORAL AB 2024-12-03 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A218282-001 CYCLOPHOSPHAMIDE 25MG CAPSULE / ORAL AB 2024-12-03 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A218282-002 CYCLOPHOSPHAMIDE 50MG CAPSULE / ORAL AB 2024-12-03 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A218282-001 CYCLOPHOSPHAMIDE 25MG CAPSULE / ORAL AB 2024-12-03 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A218282-002 CYCLOPHOSPHAMIDE 50MG CAPSULE / ORAL AB 2024-12-03 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A218282-001 CYCLOPHOSPHAMIDE 25MG CAPSULE / ORAL AB 2024-12-03 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A218282-002 CYCLOPHOSPHAMIDE 50MG CAPSULE / ORAL AB 2024-12-03 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A218282-001 CYCLOPHOSPHAMIDE 25MG CAPSULE / ORAL AB 2024-12-03 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A218282-002 CYCLOPHOSPHAMIDE 50MG CAPSULE / ORAL AB 2024-12-03 2680178bc6a6…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A218282-001 CYCLOPHOSPHAMIDE 25MG CAPSULE / ORAL AB 2024-12-03 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A218282-002 CYCLOPHOSPHAMIDE 50MG CAPSULE / ORAL AB 2024-12-03 a50c72e98297…
Observed Orange Book normalized TE history# Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Cyclophosphamide
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CYCLOPHOSPHAMIDE 25 mg/1
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 70301-2013-1 Cyclophosphamide 100 in 1 BOTTLE CAPSULE 100 1
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 70301-2013-1 70301201301 100 CAPSULE in 1 BOTTLE (70301-2013-1) 100 capsule 2026-09-16 No No Current