Home NDC 0054-0383 Cyclophosphamide
Product NDC 0054-0383
11-digit product format 000540383
Labeler code 0054
Product ID 0054-0383_35c0ebb6-6127-4e3a-9846-4ad17f7d5cd4
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Cyclophosphamide
Dosage form CAPSULE
Route ORAL
Labeler Hikma Pharmaceuticals USA Inc.
Application NDA203856
Marketing category NDA
Marketing start 2013-09-16
Substance CYCLOPHOSPHAMIDE
Active strength 50 mg/1
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 9 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
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 N203856-001 CYCLOPHOSPHAMIDE CYCLOPHOSPHAMIDE 25MG CAPSULE / ORAL AB RLD 2013-09-16 N203856-002 CYCLOPHOSPHAMIDE CYCLOPHOSPHAMIDE 50MG CAPSULE / ORAL AB RLD, RS 2013-09-16
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.
Product history page 1 of 3 · 84 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 N203856-001 CYCLOPHOSPHAMIDE 25MG CAPSULE / ORAL AB RLD 2013-09-16 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N203856-002 CYCLOPHOSPHAMIDE 50MG CAPSULE / ORAL AB RLD, RS 2013-09-16 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N203856-001 CYCLOPHOSPHAMIDE 25MG CAPSULE / ORAL AB RLD 2013-09-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N203856-002 CYCLOPHOSPHAMIDE 50MG CAPSULE / ORAL AB RLD, RS 2013-09-16 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N203856-001 CYCLOPHOSPHAMIDE 25MG CAPSULE / ORAL AB RLD 2013-09-16 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N203856-002 CYCLOPHOSPHAMIDE 50MG CAPSULE / ORAL AB RLD, RS 2013-09-16 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N203856-001 CYCLOPHOSPHAMIDE 25MG CAPSULE / ORAL AB RLD 2013-09-16 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N203856-002 CYCLOPHOSPHAMIDE 50MG CAPSULE / ORAL AB RLD, RS 2013-09-16 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N203856-001 CYCLOPHOSPHAMIDE 25MG CAPSULE / ORAL AB RLD 2013-09-16 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N203856-002 CYCLOPHOSPHAMIDE 50MG CAPSULE / ORAL AB RLD, RS 2013-09-16 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N203856-001 CYCLOPHOSPHAMIDE 25MG CAPSULE / ORAL AB RLD 2013-09-16 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N203856-002 CYCLOPHOSPHAMIDE 50MG CAPSULE / ORAL AB RLD, RS 2013-09-16 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N203856-001 CYCLOPHOSPHAMIDE 25MG CAPSULE / ORAL AB RLD 2013-09-16 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N203856-002 CYCLOPHOSPHAMIDE 50MG CAPSULE / ORAL AB RLD, RS 2013-09-16 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N203856-001 CYCLOPHOSPHAMIDE 25MG CAPSULE / ORAL AB RLD 2013-09-16 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N203856-002 CYCLOPHOSPHAMIDE 50MG CAPSULE / ORAL AB RLD, RS 2013-09-16 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N203856-001 CYCLOPHOSPHAMIDE 25MG CAPSULE / ORAL AB RLD 2013-09-16 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N203856-002 CYCLOPHOSPHAMIDE 50MG CAPSULE / ORAL AB RLD, RS 2013-09-16 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N203856-001 CYCLOPHOSPHAMIDE 25MG CAPSULE / ORAL AB RLD 2013-09-16 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N203856-002 CYCLOPHOSPHAMIDE 50MG CAPSULE / ORAL AB RLD, RS 2013-09-16 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N203856-001 CYCLOPHOSPHAMIDE 25MG CAPSULE / ORAL AB RLD 2013-09-16 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N203856-002 CYCLOPHOSPHAMIDE 50MG CAPSULE / ORAL AB RLD, RS 2013-09-16 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N203856-001 CYCLOPHOSPHAMIDE 25MG CAPSULE / ORAL AB RLD 2013-09-16 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N203856-002 CYCLOPHOSPHAMIDE 50MG CAPSULE / ORAL AB RLD, RS 2013-09-16 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N203856-001 CYCLOPHOSPHAMIDE 25MG CAPSULE / ORAL AB RLD 2013-09-16 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N203856-002 CYCLOPHOSPHAMIDE 50MG CAPSULE / ORAL AB RLD, RS 2013-09-16 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N203856-001 CYCLOPHOSPHAMIDE 25MG CAPSULE / ORAL AB RLD 2013-09-16 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N203856-002 CYCLOPHOSPHAMIDE 50MG CAPSULE / ORAL AB RLD, RS 2013-09-16 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N203856-001 CYCLOPHOSPHAMIDE 25MG CAPSULE / ORAL AB RLD 2013-09-16 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N203856-002 CYCLOPHOSPHAMIDE 50MG CAPSULE / ORAL AB RLD, RS 2013-09-16 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N203856-001 CYCLOPHOSPHAMIDE 25MG CAPSULE / ORAL AB RLD 2013-09-16 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N203856-002 CYCLOPHOSPHAMIDE 50MG CAPSULE / ORAL AB RLD, RS 2013-09-16 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N203856-001 CYCLOPHOSPHAMIDE 25MG CAPSULE / ORAL AB RLD 2013-09-16 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N203856-002 CYCLOPHOSPHAMIDE 50MG CAPSULE / ORAL AB RLD, RS 2013-09-16 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N203856-001 CYCLOPHOSPHAMIDE 25MG CAPSULE / ORAL AB RLD 2013-09-16 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N203856-002 CYCLOPHOSPHAMIDE 50MG CAPSULE / ORAL AB RLD, RS 2013-09-16 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N203856-001 CYCLOPHOSPHAMIDE 25MG CAPSULE / ORAL AB RLD 2013-09-16 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N203856-002 CYCLOPHOSPHAMIDE 50MG CAPSULE / ORAL AB RLD, RS 2013-09-16 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N203856-001 CYCLOPHOSPHAMIDE 25MG CAPSULE / ORAL AB RLD 2013-09-16 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N203856-002 CYCLOPHOSPHAMIDE 50MG CAPSULE / ORAL AB RLD, RS 2013-09-16 bb7c543d1eb4…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 84 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 50 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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1437968 Internal RxNorm lookup 1437969 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 0054-0383-13 Cyclophosphamide 30 in 1 BOTTLE CAPSULE 30 12 0054-0383-25 Cyclophosphamide 100 in 1 BOTTLE CAPSULE 100 12
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded CYCLOPHOSPHAMIDE ACTIVE INGREDIENT 8N3DW7272P CYCLOPHOSPHAMIDE CAPSULE [ROXANE LABORATORIES, INC.] 4 CYCLOPHOSPHAMIDE ANHYDROUS ACTIVE MOIETY 6UXW23996M CYCLOPHOSPHAMIDE CAPSULE [ROXANE LABORATORIES, INC.] 4 AMMONIA INACTIVE INGREDIENT 5138Q19F1X CYCLOPHOSPHAMIDE CAPSULE [ROXANE LABORATORIES, INC.] 4 BUTYL ALCOHOL INACTIVE INGREDIENT 8PJ61P6TS3 CYCLOPHOSPHAMIDE CAPSULE [ROXANE LABORATORIES, INC.] 4 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD CYCLOPHOSPHAMIDE CAPSULE [ROXANE LABORATORIES, INC.] 4 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA CYCLOPHOSPHAMIDE CAPSULE [ROXANE LABORATORIES, INC.] 4 FERROSOFERRIC OXIDE INACTIVE INGREDIENT XM0M87F357 CYCLOPHOSPHAMIDE CAPSULE [ROXANE LABORATORIES, INC.] 4 GELATIN INACTIVE INGREDIENT 2G86QN327L CYCLOPHOSPHAMIDE CAPSULE [ROXANE LABORATORIES, INC.] 4 ISOPROPYL ALCOHOL INACTIVE INGREDIENT ND2M416302 CYCLOPHOSPHAMIDE CAPSULE [ROXANE LABORATORIES, INC.] 4 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 CYCLOPHOSPHAMIDE CAPSULE [ROXANE LABORATORIES, INC.] 4 SHELLAC INACTIVE INGREDIENT 46N107B71O CYCLOPHOSPHAMIDE CAPSULE [ROXANE LABORATORIES, INC.] 4 SODIUM STEARYL FUMARATE INACTIVE INGREDIENT 7CV7WJK4UI CYCLOPHOSPHAMIDE CAPSULE [ROXANE LABORATORIES, INC.] 4 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ CYCLOPHOSPHAMIDE CAPSULE [ROXANE LABORATORIES, INC.] 4 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP CYCLOPHOSPHAMIDE CAPSULE [ROXANE LABORATORIES, INC.] 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0054-0383 CYCLOPHOSPHAMIDE CAPSULE [HIKMA PHARMACEUTICALS USA INC.] 12 Current NDC, Legacy NDC, 2 package rows 20241122_8135b917-882f-4b4c-99b7-fa8ea54af4bf.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 Marketing end Sample Exclude flag Status 0054-0383-13 00054038313 30 in 1 BOTTLE Historical 0054-0383-25 00054038325 100 CAPSULE in 1 BOTTLE (0054-0383-25) 100 capsule 2013-09-16 0000-00-00 No No Current