FDA.reportPublic FDA data

Cyclophosphamide

Product NDC
68001-443
Requested package NDC
68001-443-27
11-digit product format
680010443
Labeler code
68001
Product ID
68001-443_4a9e24ce-e6fc-6f07-e063-6394a90ab4bd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
cyclophosphamide
Dosage form
INJECTION, POWDER, FOR SOLUTION
Route
INTRAVENOUS; ORAL
Labeler
BluePoint Laboratories
Application
ANDA040745
Marketing category
ANDA
Marketing start
2020-10-19
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 1.

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A040745-001CYCLOPHOSPHAMIDE500MG/VIALINJECTABLE / INJECTIONAPRS2008-05-21a50c72e98297…
2026-08-01 22:54:322026-06A040745-002CYCLOPHOSPHAMIDE1GM/VIALINJECTABLE / INJECTIONAPRS2008-05-21a50c72e98297…
2026-08-01 22:54:322026-06A040745-003CYCLOPHOSPHAMIDE2GM/VIALINJECTABLE / INJECTIONAPRS2008-05-21a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A040745-001AP1a50c72e98297…
2026-08-01 22:54:322026-06A040745-002AP1a50c72e98297…
2026-08-01 22:54:322026-06A040745-003AP1a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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
ndc (package): 68001-443-27
ndc (product): 68001-443
ndc11 (package): 68001044327
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
CYCLOPHOSPHAMIDECYCLOPHOSPHAMIDEBaxter Healthcare Company6bae5c14-9e87-4fb6-ae9c-4d875c1ecffe2017-03-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040745
application number: ANDA040745

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
d7e97b99-83db-42d0-8521-b87fe6467a67Available 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
68001-443-27Cyclophosphamide1 in 1 CARTONINJECTION, POWDER, FOR SOLUTION14
68001-443-27Cyclophosphamide50 mL in 1 VIAL, SINGLE-DOSEINJECTION, POWDER, FOR SOLUTION504

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68001-443CYCLOPHOSPHAMIDE INJECTION, POWDER, FOR SOLUTION [BLUEPOINT LABORATORIES]3Current NDC, Legacy NDC, 2 package rows20250406_d7e97b99-83db-42d0-8521-b87fe6467a67.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1734919cycloPHOSphamide 1 GM InjectionPSNd7e97b99-83db-42d0-8521-b87fe6467a674
1734921cycloPHOSphamide 2 GM InjectionPSNd7e97b99-83db-42d0-8521-b87fe6467a674
1734917cycloPHOSphamide 500 MG InjectionPSNd7e97b99-83db-42d0-8521-b87fe6467a674
1734919cyclophosphamide 1000 MG InjectionSCDd7e97b99-83db-42d0-8521-b87fe6467a674
1734921cyclophosphamide 2000 MG InjectionSCDd7e97b99-83db-42d0-8521-b87fe6467a674
1734917cyclophosphamide 500 MG InjectionSCDd7e97b99-83db-42d0-8521-b87fe6467a674
1734919cyclophosphamide (as cyclophosphamide monohydrate) 1000 MG InjectionSYd7e97b99-83db-42d0-8521-b87fe6467a674
1734921cyclophosphamide (as cyclophosphamide monohydrate) 2000 MG InjectionSYd7e97b99-83db-42d0-8521-b87fe6467a674
1734917cyclophosphamide (as cyclophosphamide monohydrate) 500 MG InjectionSYd7e97b99-83db-42d0-8521-b87fe6467a674
1734919cyclophosphamide 1 GM InjectionSYd7e97b99-83db-42d0-8521-b87fe6467a674
1734921cyclophosphamide 2 GM InjectionSYd7e97b99-83db-42d0-8521-b87fe6467a674

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68001-443-27680010443271 VIAL, SINGLE-DOSE in 1 CARTON (68001-443-27) / 50 mL in 1 VIAL, SINGLE-DOSE2020-10-190000-00-00NoNoCurrent