CYCLOPHOSPHAMIDE

Product NDC
10019-944
11-digit product format
100190944
Labeler code
10019
Product ID
10019-944_3d950615-927d-441e-b3be-0cebda594df5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
cyclophosphamide
Dosage form
INJECTION, POWDER, FOR SOLUTION
Route
INTRAVENOUS; ORAL
Labeler
Baxter Healthcare Company
Application
ANDA040745
Marketing category
ANDA
Marketing start
2008-05-21
Substance
CYCLOPHOSPHAMIDE
Active strength
1 g/50mL
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 42.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A040745-001CYCLOPHOSPHAMIDECYCLOPHOSPHAMIDE500MG/VIALINJECTABLE / INJECTIONAPRS2008-05-21
A040745-002CYCLOPHOSPHAMIDECYCLOPHOSPHAMIDE1GM/VIALINJECTABLE / INJECTIONAPRS2008-05-21
A040745-003CYCLOPHOSPHAMIDECYCLOPHOSPHAMIDE2GM/VIALINJECTABLE / INJECTIONAPRS2008-05-21

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
A040745-001AP
A040745-002AP
A040745-003AP

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 4 · 126 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A040745-001CYCLOPHOSPHAMIDE500MG/VIALINJECTABLE / INJECTIONAPRS2008-05-21caaa826d4ba7…
2026-08-18 06:07:402026-07A040745-002CYCLOPHOSPHAMIDE1GM/VIALINJECTABLE / INJECTIONAPRS2008-05-21caaa826d4ba7…
2026-08-18 06:07:402026-07A040745-003CYCLOPHOSPHAMIDE2GM/VIALINJECTABLE / INJECTIONAPRS2008-05-21caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A040745-001CYCLOPHOSPHAMIDE500MG/VIALINJECTABLE / INJECTIONAPRS2008-05-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040745-002CYCLOPHOSPHAMIDE1GM/VIALINJECTABLE / INJECTIONAPRS2008-05-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040745-003CYCLOPHOSPHAMIDE2GM/VIALINJECTABLE / INJECTIONAPRS2008-05-21011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040745-001CYCLOPHOSPHAMIDE500MG/VIALINJECTABLE / INJECTIONAPRS2008-05-2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040745-002CYCLOPHOSPHAMIDE1GM/VIALINJECTABLE / INJECTIONAPRS2008-05-2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040745-003CYCLOPHOSPHAMIDE2GM/VIALINJECTABLE / INJECTIONAPRS2008-05-2131067a03dcf5…
2025-08-23 18:47 UTC2025-08A040745-001CYCLOPHOSPHAMIDE500MG/VIALINJECTABLE / INJECTIONAPRS2008-05-216a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040745-002CYCLOPHOSPHAMIDE1GM/VIALINJECTABLE / INJECTIONAPRS2008-05-216a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040745-003CYCLOPHOSPHAMIDE2GM/VIALINJECTABLE / INJECTIONAPRS2008-05-216a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040745-001CYCLOPHOSPHAMIDE500MG/VIALINJECTABLE / INJECTIONAPRS2008-05-21fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040745-002CYCLOPHOSPHAMIDE1GM/VIALINJECTABLE / INJECTIONAPRS2008-05-21fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040745-003CYCLOPHOSPHAMIDE2GM/VIALINJECTABLE / INJECTIONAPRS2008-05-21fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040745-001CYCLOPHOSPHAMIDE500MG/VIALINJECTABLE / INJECTIONAPRS2008-05-21b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040745-002CYCLOPHOSPHAMIDE1GM/VIALINJECTABLE / INJECTIONAPRS2008-05-21b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040745-003CYCLOPHOSPHAMIDE2GM/VIALINJECTABLE / INJECTIONAPRS2008-05-21b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040745-001CYCLOPHOSPHAMIDE500MG/VIALINJECTABLE / INJECTIONAPRS2008-05-2103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040745-002CYCLOPHOSPHAMIDE1GM/VIALINJECTABLE / INJECTIONAPRS2008-05-2103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040745-003CYCLOPHOSPHAMIDE2GM/VIALINJECTABLE / INJECTIONAPRS2008-05-2103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040745-001CYCLOPHOSPHAMIDE500MG/VIALINJECTABLE / INJECTIONAPRS2008-05-212680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040745-002CYCLOPHOSPHAMIDE1GM/VIALINJECTABLE / INJECTIONAPRS2008-05-212680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040745-003CYCLOPHOSPHAMIDE2GM/VIALINJECTABLE / INJECTIONAPRS2008-05-212680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040745-001CYCLOPHOSPHAMIDE500MG/VIALINJECTABLE / INJECTIONAPRS2008-05-215bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040745-002CYCLOPHOSPHAMIDE1GM/VIALINJECTABLE / INJECTIONAPRS2008-05-215bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040745-003CYCLOPHOSPHAMIDE2GM/VIALINJECTABLE / INJECTIONAPRS2008-05-215bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040745-001CYCLOPHOSPHAMIDE500MG/VIALINJECTABLE / INJECTIONAPRS2008-05-21d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040745-002CYCLOPHOSPHAMIDE1GM/VIALINJECTABLE / INJECTIONAPRS2008-05-21d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040745-003CYCLOPHOSPHAMIDE2GM/VIALINJECTABLE / INJECTIONAPRS2008-05-21d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A040745-001CYCLOPHOSPHAMIDE500MG/VIALINJECTABLE / INJECTIONAPRS2008-05-21d06236e962d9…
2024-10-29 15:01 UTC2024-10A040745-002CYCLOPHOSPHAMIDE1GM/VIALINJECTABLE / INJECTIONAPRS2008-05-21d06236e962d9…
2024-10-29 15:01 UTC2024-10A040745-003CYCLOPHOSPHAMIDE2GM/VIALINJECTABLE / INJECTIONAPRS2008-05-21d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040745-001CYCLOPHOSPHAMIDE500MG/VIALINJECTABLE / INJECTIONAPRS2008-05-2179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040745-002CYCLOPHOSPHAMIDE1GM/VIALINJECTABLE / INJECTIONAPRS2008-05-2179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040745-003CYCLOPHOSPHAMIDE2GM/VIALINJECTABLE / INJECTIONAPRS2008-05-2179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040745-001CYCLOPHOSPHAMIDE500MG/VIALINJECTABLE / INJECTIONAPRS2008-05-21301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040745-002CYCLOPHOSPHAMIDE1GM/VIALINJECTABLE / INJECTIONAPRS2008-05-21301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040745-003CYCLOPHOSPHAMIDE2GM/VIALINJECTABLE / INJECTIONAPRS2008-05-21301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040745-001CYCLOPHOSPHAMIDE500MG/VIALINJECTABLE / INJECTIONAPRS2008-05-211e350fbaab3a…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 126 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A040745-001AP1caaa826d4ba7…
2026-08-18 06:07:402026-07A040745-002AP1caaa826d4ba7…
2026-08-18 06:07:402026-07A040745-003AP1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A040745-001AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040745-002AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040745-003AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040745-001AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040745-002AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040745-003AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08A040745-001AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040745-002AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040745-003AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040745-001AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040745-002AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040745-003AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040745-001AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040745-002AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040745-003AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040745-001AP103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040745-002AP103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040745-003AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040745-001AP12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040745-002AP12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040745-003AP12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040745-001AP15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040745-002AP15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040745-003AP15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040745-001AP1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040745-002AP1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040745-003AP1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A040745-001AP1d06236e962d9…
2024-10-29 15:01 UTC2024-10A040745-002AP1d06236e962d9…
2024-10-29 15:01 UTC2024-10A040745-003AP1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040745-001AP179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040745-002AP179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040745-003AP179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040745-001AP1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040745-002AP1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040745-003AP1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040745-001AP11e350fbaab3a…

Additional Listing Data#

Finished product
Yes
Brand name base
CYCLOPHOSPHAMIDE
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CYCLOPHOSPHAMIDE1 g/50mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
8N3DW7272PInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1734917Internal RxNorm lookup
1734919Internal RxNorm lookup
1734921Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
cef038cc-efab-46d9-99c2-95bb11d6c9bcAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0db1850b-2dc3-47a1-8b35-fab6e1685124Product name320250814
0b38b013-6fe7-0a7a-ece2-0a10ca467a97Product name420250801
f22fb018-dc36-4ffa-a765-94776b98899bProduct name120250620
e71baeca-a07a-452b-ba2b-50be55aedc79Product name220250617
913f6711-71c9-4a3d-a6d5-98cbd101b5d8Product name120231023
cd3d0a71-dbf2-4640-91f7-c99c45edfbb6Product name120231023
fbc3d08d-10bd-4e59-b59d-d530aede5badProduct name120220308

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10019-944-01CYCLOPHOSPHAMIDE1 in 1 CARTONINJECTION, POWDER, FOR SOLUTION115
10019-944-50CYCLOPHOSPHAMIDE50 mL in 1 VIAL, SINGLE-DOSEINJECTION, POWDER, FOR SOLUTION5015

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
10019-944-01EA - Each10019-944f3d382ad-80b6-45b2-a131-c224e6cbb4d912015-01-05
10019-944-50EA - Each10019-944d2d586f9-63c6-4409-bcf2-8eb4bbc25d7912015-04-03

DailyMed Socrata Ingredients#

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10019-944CYCLOPHOSPHAMIDE INJECTION, POWDER, FOR SOLUTION [BAXTER HEALTHCARE CORPORATION]13Current NDC, Legacy NDC, 2 package rows20250519_cef038cc-efab-46d9-99c2-95bb11d6c9bc.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 · 7 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CyclophosphamideCYCLOPHOSPHAMIDEBluePoint Laboratoriesd7e97b99-83db-42d0-8521-b87fe6467a672026-02-12Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040745
application number: ANDA040745
CYCLOPHOSPHAMIDECYCLOPHOSPHAMIDEBamboo US Bidco LCC2873b99a-830d-0a7b-e063-6394a90a4de72025-12-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040745
application number: ANDA040745
CyclophosphamideCYCLOPHOSPHAMIDECivica, Inc.8627c83f-c057-495d-9f78-8b67bda97b3e2025-10-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040745
application number: ANDA040745
CyclophosphamideCYCLOPHOSPHAMIDEBaxter Healthcare Company591d9955-3d9c-4cdc-a308-2f1288376b9f2025-06-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040745
application number: ANDA040745
CYCLOPHOSPHAMIDECYCLOPHOSPHAMIDEBaxter Healthcare Company97ab446f-5017-4180-ae65-0a355289b0ed2025-06-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040745
application number: ANDA040745
CYCLOPHOSPHAMIDECYCLOPHOSPHAMIDEBaxter Healthcare Companycef038cc-efab-46d9-99c2-95bb11d6c9bc2017-03-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040745
application number: ANDA040745
ndc (product): 10019-944
CYCLOPHOSPHAMIDECYCLOPHOSPHAMIDEBaxter Healthcare Company6bae5c14-9e87-4fb6-ae9c-4d875c1ecffe2017-03-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040745
application number: ANDA040745

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1734919cycloPHOSphamide 1 GM InjectionPSNcef038cc-efab-46d9-99c2-95bb11d6c9bc15
1734921cycloPHOSphamide 2 GM InjectionPSNcef038cc-efab-46d9-99c2-95bb11d6c9bc15
1734917cycloPHOSphamide 500 MG InjectionPSNcef038cc-efab-46d9-99c2-95bb11d6c9bc15
1734919cyclophosphamide 1000 MG InjectionSCDcef038cc-efab-46d9-99c2-95bb11d6c9bc15
1734921cyclophosphamide 2000 MG InjectionSCDcef038cc-efab-46d9-99c2-95bb11d6c9bc15
1734917cyclophosphamide 500 MG InjectionSCDcef038cc-efab-46d9-99c2-95bb11d6c9bc15
1734919cyclophosphamide (as cyclophosphamide monohydrate) 1000 MG InjectionSYcef038cc-efab-46d9-99c2-95bb11d6c9bc15
1734921cyclophosphamide (as cyclophosphamide monohydrate) 2000 MG InjectionSYcef038cc-efab-46d9-99c2-95bb11d6c9bc15
1734917cyclophosphamide (as cyclophosphamide monohydrate) 500 MG InjectionSYcef038cc-efab-46d9-99c2-95bb11d6c9bc15
1734919cyclophosphamide 1 GM InjectionSYcef038cc-efab-46d9-99c2-95bb11d6c9bc15
1734921cyclophosphamide 2 GM InjectionSYcef038cc-efab-46d9-99c2-95bb11d6c9bc15

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
10019-944-01100190944011 VIAL, SINGLE-DOSE in 1 CARTON (10019-944-01) / 50 mL in 1 VIAL, SINGLE-DOSE (10019-944-50) 2008-05-210000-00-00NoNoCurrent
10019-944-501001909445050 mL in 1 VIAL, SINGLE-DOSE50 mlHistorical