FDA.reportPublic FDA data

Cyclophosphamide

Product NDC
14335-472
11-digit product format
143350472
Labeler code
14335
Product ID
14335-472_2aca7731-9fcc-4625-e063-6394a90a6020
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cyclophosphamide for Injection
Dosage form
INJECTION, POWDER, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Hainan Poly Pharm. Co., Ltd.
Application
ANDA218632
Marketing category
ANDA
Marketing start
2025-01-03
Substance
CYCLOPHOSPHAMIDE
Active strength
2 g/100mL
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
CYCLOPHOSPHAMIDE2 g/100mL

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
6fde2705-a2d8-4d48-9618-b9d99d051373Available 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
14335-472-01Cyclophosphamide100 mL in 1 VIAL, SINGLE-DOSEINJECTION, POWDER, FOR SOLUTION1001
14335-472-10Cyclophosphamide1 in 1 CARTONINJECTION, POWDER, FOR SOLUTION11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
14335-472CYCLOPHOSPHAMIDE (CYCLOPHOSPHAMIDE FOR INJECTION) INJECTION, POWDER, FOR SOLUTION [HAINAN POLY PHARM. CO., LTD.]1Current NDC, 2 package rows20250104_6fde2705-a2d8-4d48-9618-b9d99d051373.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
CyclophosphamideCYCLOPHOSPHAMIDE FOR INJECTIONHainan Poly Pharm. Co., Ltd.6fde2705-a2d8-4d48-9618-b9d99d0513732025-01-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 218632
application number: ANDA218632
ndc (product): 14335-472

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1734919cycloPHOSphamide 1 GM InjectionPSN6fde2705-a2d8-4d48-9618-b9d99d0513731
1734921cycloPHOSphamide 2 GM InjectionPSN6fde2705-a2d8-4d48-9618-b9d99d0513731
1734917cycloPHOSphamide 500 MG InjectionPSN6fde2705-a2d8-4d48-9618-b9d99d0513731
1734919cyclophosphamide 1000 MG InjectionSCD6fde2705-a2d8-4d48-9618-b9d99d0513731
1734921cyclophosphamide 2000 MG InjectionSCD6fde2705-a2d8-4d48-9618-b9d99d0513731
1734917cyclophosphamide 500 MG InjectionSCD6fde2705-a2d8-4d48-9618-b9d99d0513731
1734919cyclophosphamide (as cyclophosphamide monohydrate) 1000 MG InjectionSY6fde2705-a2d8-4d48-9618-b9d99d0513731
1734921cyclophosphamide (as cyclophosphamide monohydrate) 2000 MG InjectionSY6fde2705-a2d8-4d48-9618-b9d99d0513731
1734917cyclophosphamide (as cyclophosphamide monohydrate) 500 MG InjectionSY6fde2705-a2d8-4d48-9618-b9d99d0513731
1734919cyclophosphamide 1 GM InjectionSY6fde2705-a2d8-4d48-9618-b9d99d0513731
1734921cyclophosphamide 2 GM InjectionSY6fde2705-a2d8-4d48-9618-b9d99d0513731

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
14335-472-0114335047201100 mL in 1 VIAL, SINGLE-DOSE100 mlHistorical
14335-472-10143350472101 VIAL, SINGLE-DOSE in 1 CARTON (14335-472-10) / 100 mL in 1 VIAL, SINGLE-DOSE (14335-472-01) 2025-01-03NoNoCurrent