FDA.reportPublic FDA data

CYCLOPHOSPHAMIDE

Product NDC
10019-989
11-digit product format
100190989
Labeler code
10019
Product ID
10019-989_3082cff4-7019-42cf-ae82-ac5af74af797
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cyclophosphamide
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAVENOUS; ORAL
Labeler
Baxter Healthcare Corporation
Application
NDA012142
Marketing category
NDA
Marketing start
1959-11-16
Marketing end
0000-00-00
Substance
CYCLOPHOSPHAMIDE
Active strength
1 g/50mL
Pharmacologic classes
Alkylating Activity [MoA],Alkylating Drug [EPC]
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct10019-989DDiscontinued by firm2026-08-17
excluded packagepackage10019-98910019-989-01DDiscontinued by firm2026-08-17

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 · 24 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage10019-989-01d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage10019-989-01f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage10019-989-012ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage10019-989-01a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage10019-989-01cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage10019-989-01cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage10019-989-01302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage10019-989-01ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage10019-989-010efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage10019-989-01ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage10019-989-01367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage10019-989-01557ba5c1ecfa…9c80585c8c6e…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 10 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N012142-001CYTOXANCYCLOPHOSPHAMIDE100MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD, Approved before 1982
N012142-002CYTOXANCYCLOPHOSPHAMIDE200MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD, Approved before 1982
N012142-003CYTOXAN (LYOPHILIZED)CYCLOPHOSPHAMIDE500MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD, Approved before 1982
N012142-004CYTOXAN (LYOPHILIZED)CYCLOPHOSPHAMIDE1GM/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD1982-08-30
N012142-005CYTOXAN (LYOPHILIZED)CYCLOPHOSPHAMIDE2GM/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD1982-08-30
N012142-006LYOPHILIZED CYTOXANCYCLOPHOSPHAMIDE100MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD1985-12-05
N012142-007LYOPHILIZED CYTOXANCYCLOPHOSPHAMIDE200MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD1985-12-10
N012142-008CYTOXAN (LYOPHILIZED)CYCLOPHOSPHAMIDE500MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD1984-01-04
N012142-009CYTOXAN (LYOPHILIZED)CYCLOPHOSPHAMIDE2GM/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD1985-12-10
N012142-010CYTOXAN (LYOPHILIZED)CYCLOPHOSPHAMIDE1GM/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD1985-09-24

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 11 · 420 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07N012142-001CYTOXAN100MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD, Approved before 1982caaa826d4ba7…
2026-08-18 06:07:402026-07N012142-002CYTOXAN200MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD, Approved before 1982caaa826d4ba7…
2026-08-18 06:07:402026-07N012142-003CYTOXAN (LYOPHILIZED)500MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD, Approved before 1982caaa826d4ba7…
2026-08-18 06:07:402026-07N012142-004CYTOXAN (LYOPHILIZED)1GM/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD1982-08-30caaa826d4ba7…
2026-08-18 06:07:402026-07N012142-005CYTOXAN (LYOPHILIZED)2GM/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD1982-08-30caaa826d4ba7…
2026-08-18 06:07:402026-07N012142-006LYOPHILIZED CYTOXAN100MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD1985-12-05caaa826d4ba7…
2026-08-18 06:07:402026-07N012142-007LYOPHILIZED CYTOXAN200MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD1985-12-10caaa826d4ba7…
2026-08-18 06:07:402026-07N012142-008CYTOXAN (LYOPHILIZED)500MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD1984-01-04caaa826d4ba7…
2026-08-18 06:07:402026-07N012142-009CYTOXAN (LYOPHILIZED)2GM/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD1985-12-10caaa826d4ba7…
2026-08-18 06:07:402026-07N012142-010CYTOXAN (LYOPHILIZED)1GM/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD1985-09-24caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N012142-001CYTOXAN100MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD, Approved before 1982011fe1cb6892…
2026-02-19 14:30 UTC2026-02N012142-002CYTOXAN200MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD, Approved before 1982011fe1cb6892…
2026-02-19 14:30 UTC2026-02N012142-003CYTOXAN (LYOPHILIZED)500MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD, Approved before 1982011fe1cb6892…
2026-02-19 14:30 UTC2026-02N012142-004CYTOXAN (LYOPHILIZED)1GM/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD1982-08-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02N012142-005CYTOXAN (LYOPHILIZED)2GM/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD1982-08-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02N012142-006LYOPHILIZED CYTOXAN100MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD1985-12-05011fe1cb6892…
2026-02-19 14:30 UTC2026-02N012142-007LYOPHILIZED CYTOXAN200MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD1985-12-10011fe1cb6892…
2026-02-19 14:30 UTC2026-02N012142-008CYTOXAN (LYOPHILIZED)500MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD1984-01-04011fe1cb6892…
2026-02-19 14:30 UTC2026-02N012142-009CYTOXAN (LYOPHILIZED)2GM/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD1985-12-10011fe1cb6892…
2026-02-19 14:30 UTC2026-02N012142-010CYTOXAN (LYOPHILIZED)1GM/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD1985-09-24011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N012142-001CYTOXAN100MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD, Approved before 198231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N012142-002CYTOXAN200MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD, Approved before 198231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N012142-003CYTOXAN (LYOPHILIZED)500MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD, Approved before 198231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N012142-004CYTOXAN (LYOPHILIZED)1GM/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD1982-08-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N012142-005CYTOXAN (LYOPHILIZED)2GM/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD1982-08-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N012142-006LYOPHILIZED CYTOXAN100MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD1985-12-0531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N012142-007LYOPHILIZED CYTOXAN200MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD1985-12-1031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N012142-008CYTOXAN (LYOPHILIZED)500MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD1984-01-0431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N012142-009CYTOXAN (LYOPHILIZED)2GM/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD1985-12-1031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N012142-010CYTOXAN (LYOPHILIZED)1GM/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD1985-09-2431067a03dcf5…
2025-08-23 18:47 UTC2025-08N012142-001CYTOXAN100MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD, Approved before 19826a471c1ec25d…
2025-08-23 18:47 UTC2025-08N012142-002CYTOXAN200MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD, Approved before 19826a471c1ec25d…
2025-08-23 18:47 UTC2025-08N012142-003CYTOXAN (LYOPHILIZED)500MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD, Approved before 19826a471c1ec25d…
2025-08-23 18:47 UTC2025-08N012142-004CYTOXAN (LYOPHILIZED)1GM/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD1982-08-306a471c1ec25d…
2025-08-23 18:47 UTC2025-08N012142-005CYTOXAN (LYOPHILIZED)2GM/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD1982-08-306a471c1ec25d…
2025-08-23 18:47 UTC2025-08N012142-006LYOPHILIZED CYTOXAN100MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD1985-12-056a471c1ec25d…
2025-08-23 18:47 UTC2025-08N012142-007LYOPHILIZED CYTOXAN200MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD1985-12-106a471c1ec25d…
2025-08-23 18:47 UTC2025-08N012142-008CYTOXAN (LYOPHILIZED)500MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD1984-01-046a471c1ec25d…
2025-08-23 18:47 UTC2025-08N012142-009CYTOXAN (LYOPHILIZED)2GM/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD1985-12-106a471c1ec25d…
2025-08-23 18:47 UTC2025-08N012142-010CYTOXAN (LYOPHILIZED)1GM/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD1985-09-246a471c1ec25d…

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CYCLOPHOSPHAMIDEACTIVE INGREDIENT8N3DW7272PCYCLOPHOSPHAMIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [BAXTER HEALTHCARE CORPORATION]2
CYCLOPHOSPHAMIDE ANHYDROUSACTIVE MOIETY6UXW23996MCYCLOPHOSPHAMIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [BAXTER HEALTHCARE CORPORATION]2
MANNITOLINACTIVE INGREDIENT3OWL53L36ACYCLOPHOSPHAMIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [BAXTER HEALTHCARE CORPORATION]2