FDA.reportPublic FDA data

Cyclophosphamide

Product NDC
70436-106
11-digit product format
704360106
Labeler code
70436
Product ID
70436-106_31c60f0f-f81b-a187-e063-6394a90aa39d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cyclophosphamide for Injection
Dosage form
INJECTION, POWDER, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Slate Run Pharmaceuticals, LLC
Application
ANDA218632
Marketing category
ANDA
Marketing start
2025-03-26
Substance
CYCLOPHOSPHAMIDE
Active strength
1 g/50mL
NDC exclude flag
No
Listing certified through
2026-12-31
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
A218632-001CYCLOPHOSPHAMIDECYCLOPHOSPHAMIDE500MG/VIALINJECTABLE / INJECTION2024-12-26
A218632-002CYCLOPHOSPHAMIDECYCLOPHOSPHAMIDE1GM/VIALINJECTABLE / INJECTION2024-12-26
A218632-003CYCLOPHOSPHAMIDECYCLOPHOSPHAMIDE2GM/VIALINJECTABLE / INJECTION2024-12-26

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
2026-08-18 06:07:402026-07A218632-001CYCLOPHOSPHAMIDE500MG/VIALINJECTABLE / INJECTION2024-12-26caaa826d4ba7…
2026-08-18 06:07:402026-07A218632-002CYCLOPHOSPHAMIDE1GM/VIALINJECTABLE / INJECTION2024-12-26caaa826d4ba7…
2026-08-18 06:07:402026-07A218632-003CYCLOPHOSPHAMIDE2GM/VIALINJECTABLE / INJECTION2024-12-26caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A218632-001CYCLOPHOSPHAMIDE500MG/VIALINJECTABLE / INJECTION2024-12-26011fe1cb6892…
2026-02-19 14:30 UTC2026-02A218632-002CYCLOPHOSPHAMIDE1GM/VIALINJECTABLE / INJECTION2024-12-26011fe1cb6892…
2026-02-19 14:30 UTC2026-02A218632-003CYCLOPHOSPHAMIDE2GM/VIALINJECTABLE / INJECTION2024-12-26011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A218632-001CYCLOPHOSPHAMIDE500MG/VIALINJECTABLE / INJECTIONAP2024-12-2631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A218632-002CYCLOPHOSPHAMIDE1GM/VIALINJECTABLE / INJECTIONAP2024-12-2631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A218632-003CYCLOPHOSPHAMIDE2GM/VIALINJECTABLE / INJECTIONAP2024-12-2631067a03dcf5…
2025-08-23 18:47 UTC2025-08A218632-001CYCLOPHOSPHAMIDE500MG/VIALINJECTABLE / INJECTIONAP2024-12-266a471c1ec25d…
2025-08-23 18:47 UTC2025-08A218632-002CYCLOPHOSPHAMIDE1GM/VIALINJECTABLE / INJECTIONAP2024-12-266a471c1ec25d…
2025-08-23 18:47 UTC2025-08A218632-003CYCLOPHOSPHAMIDE2GM/VIALINJECTABLE / INJECTIONAP2024-12-266a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A218632-001CYCLOPHOSPHAMIDE500MG/VIALINJECTABLE / INJECTIONAP2024-12-26fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A218632-002CYCLOPHOSPHAMIDE1GM/VIALINJECTABLE / INJECTIONAP2024-12-26fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A218632-003CYCLOPHOSPHAMIDE2GM/VIALINJECTABLE / INJECTIONAP2024-12-26fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A218632-001CYCLOPHOSPHAMIDE500MG/VIALINJECTABLE / INJECTIONAP2024-12-26b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A218632-002CYCLOPHOSPHAMIDE1GM/VIALINJECTABLE / INJECTIONAP2024-12-26b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A218632-003CYCLOPHOSPHAMIDE2GM/VIALINJECTABLE / INJECTIONAP2024-12-26b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A218632-001CYCLOPHOSPHAMIDE500MG/VIALINJECTABLE / INJECTIONAP2024-12-2603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A218632-002CYCLOPHOSPHAMIDE1GM/VIALINJECTABLE / INJECTIONAP2024-12-2603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A218632-003CYCLOPHOSPHAMIDE2GM/VIALINJECTABLE / INJECTIONAP2024-12-2603ed91905a0d…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A218632-001CYCLOPHOSPHAMIDE500MG/VIALINJECTABLE / INJECTION2024-12-26a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A218632-002CYCLOPHOSPHAMIDE1GM/VIALINJECTABLE / INJECTION2024-12-26a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A218632-003CYCLOPHOSPHAMIDE2GM/VIALINJECTABLE / INJECTION2024-12-26a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A218632-001AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A218632-002AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A218632-003AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08A218632-001AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A218632-002AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A218632-003AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A218632-001AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A218632-002AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A218632-003AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A218632-001AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A218632-002AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A218632-003AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A218632-001AP103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A218632-002AP103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A218632-003AP103ed91905a0d…

Additional Listing Data#

Finished product
Yes
Brand name base
Cyclophosphamide
Listing expiration
2026-12-31

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
20bda486-cb9a-4d67-8c41-50e9fd066434Available 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
70436-106-80Cyclophosphamide1 in 1 CARTONINJECTION, POWDER, FOR SOLUTION11
70436-106-80Cyclophosphamide50 mL in 1 VIAL, SINGLE-DOSEINJECTION, POWDER, FOR SOLUTION501

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70436-106CYCLOPHOSPHAMIDE (CYCLOPHOSPHAMIDE FOR INJECTION) INJECTION, POWDER, FOR SOLUTION [SLATE RUN PHARMACEUTICALS, LLC]1Current NDC, 2 package rows20250406_20bda486-cb9a-4d67-8c41-50e9fd066434.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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CyclophosphamideCYCLOPHOSPHAMIDE FOR INJECTIONSlate Run Pharmaceuticals, LLC20bda486-cb9a-4d67-8c41-50e9fd0664342025-04-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 218632
application number: ANDA218632
ndc (product): 70436-106
CyclophosphamideCYCLOPHOSPHAMIDE FOR INJECTIONHainan Poly Pharm. Co., Ltd.6fde2705-a2d8-4d48-9618-b9d99d0513732025-01-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 218632
application number: ANDA218632

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1734919cycloPHOSphamide 1 GM InjectionPSN20bda486-cb9a-4d67-8c41-50e9fd0664341
1734921cycloPHOSphamide 2 GM InjectionPSN20bda486-cb9a-4d67-8c41-50e9fd0664341
1734917cycloPHOSphamide 500 MG InjectionPSN20bda486-cb9a-4d67-8c41-50e9fd0664341
1734919cyclophosphamide 1000 MG InjectionSCD20bda486-cb9a-4d67-8c41-50e9fd0664341
1734921cyclophosphamide 2000 MG InjectionSCD20bda486-cb9a-4d67-8c41-50e9fd0664341
1734917cyclophosphamide 500 MG InjectionSCD20bda486-cb9a-4d67-8c41-50e9fd0664341
1734919cyclophosphamide (as cyclophosphamide monohydrate) 1000 MG InjectionSY20bda486-cb9a-4d67-8c41-50e9fd0664341
1734921cyclophosphamide (as cyclophosphamide monohydrate) 2000 MG InjectionSY20bda486-cb9a-4d67-8c41-50e9fd0664341
1734917cyclophosphamide (as cyclophosphamide monohydrate) 500 MG InjectionSY20bda486-cb9a-4d67-8c41-50e9fd0664341
1734919cyclophosphamide 1 GM InjectionSY20bda486-cb9a-4d67-8c41-50e9fd0664341
1734921cyclophosphamide 2 GM InjectionSY20bda486-cb9a-4d67-8c41-50e9fd0664341

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
70436-106-80704360106801 VIAL, SINGLE-DOSE in 1 CARTON (70436-106-80) / 50 mL in 1 VIAL, SINGLE-DOSE2025-03-26NoNoCurrent