Home NDC 70301-2013-1 Cyclophosphamide
Product NDC 70301-2013
Requested package NDC 70301-2013-1
11-digit product format 703012013
Labeler code 70301
Product ID 70301-2013_5100a9aa-5e4b-1edb-e063-6294a90a174e
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name CYCLOPHOSPHAMIDE
Dosage form CAPSULE
Route ORAL
Labeler OPKO Pharmaceuticals, LLC
Application ANDA218282
Marketing category ANDA
Marketing start 2026-04-20
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 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 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 2026-02-19 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# 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
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 1437968 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 70301-2013-1 Cyclophosphamide 100 in 1 BOTTLE CAPSULE 100 1
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 · 2 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 70301-2013-1 70301201301 100 CAPSULE in 1 BOTTLE (70301-2013-1) 100 capsule 2026-04-20 No No Current