FDA.reportPublic FDA data

Cyclophosphamide

Product NDC
83634-206
11-digit product format
836340206
Labeler code
83634
Product ID
83634-206_fd5fc06c-b5e5-4e07-acdb-26e56bfa2c7f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
cyclophosphamide
Dosage form
INJECTION, POWDER, FOR SOLUTION
Route
INTRAVENOUS; ORAL
Labeler
Avenacy, LLC
Application
ANDA218644
Marketing category
ANDA
Marketing start
2026-02-01
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 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
A218644-001CYCLOPHOSPHAMIDECYCLOPHOSPHAMIDE500MG/VIALINJECTABLE / INJECTIONAP2024-12-19
A218644-002CYCLOPHOSPHAMIDECYCLOPHOSPHAMIDE1GM/VIALINJECTABLE / INJECTIONAP2024-12-19
A218644-003CYCLOPHOSPHAMIDECYCLOPHOSPHAMIDE2GM/VIALINJECTABLE / INJECTIONAP2024-12-19

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A218644-001AP
A218644-002AP
A218644-003AP

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
2026-02-19 14:30 UTC2026-02A218644-001CYCLOPHOSPHAMIDE500MG/VIALINJECTABLE / INJECTIONAP2024-12-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02A218644-002CYCLOPHOSPHAMIDE1GM/VIALINJECTABLE / INJECTIONAP2024-12-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02A218644-003CYCLOPHOSPHAMIDE2GM/VIALINJECTABLE / INJECTIONAP2024-12-19011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A218644-001CYCLOPHOSPHAMIDE500MG/VIALINJECTABLE / INJECTIONAP2024-12-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A218644-002CYCLOPHOSPHAMIDE1GM/VIALINJECTABLE / INJECTIONAP2024-12-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A218644-003CYCLOPHOSPHAMIDE2GM/VIALINJECTABLE / INJECTIONAP2024-12-1931067a03dcf5…
2025-08-23 18:47 UTC2025-08A218644-001CYCLOPHOSPHAMIDE500MG/VIALINJECTABLE / INJECTIONAP2024-12-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08A218644-002CYCLOPHOSPHAMIDE1GM/VIALINJECTABLE / INJECTIONAP2024-12-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08A218644-003CYCLOPHOSPHAMIDE2GM/VIALINJECTABLE / INJECTIONAP2024-12-196a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A218644-001CYCLOPHOSPHAMIDE500MG/VIALINJECTABLE / INJECTIONAP2024-12-19fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A218644-002CYCLOPHOSPHAMIDE1GM/VIALINJECTABLE / INJECTIONAP2024-12-19fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A218644-003CYCLOPHOSPHAMIDE2GM/VIALINJECTABLE / INJECTIONAP2024-12-19fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A218644-001CYCLOPHOSPHAMIDE500MG/VIALINJECTABLE / INJECTIONAP2024-12-19b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A218644-002CYCLOPHOSPHAMIDE1GM/VIALINJECTABLE / INJECTIONAP2024-12-19b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A218644-003CYCLOPHOSPHAMIDE2GM/VIALINJECTABLE / INJECTIONAP2024-12-19b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A218644-001CYCLOPHOSPHAMIDE500MG/VIALINJECTABLE / INJECTIONAP2024-12-1903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A218644-002CYCLOPHOSPHAMIDE1GM/VIALINJECTABLE / INJECTIONAP2024-12-1903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A218644-003CYCLOPHOSPHAMIDE2GM/VIALINJECTABLE / INJECTIONAP2024-12-1903ed91905a0d…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A218644-001CYCLOPHOSPHAMIDE500MG/VIALINJECTABLE / INJECTIONAP2024-12-19a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A218644-002CYCLOPHOSPHAMIDE1GM/VIALINJECTABLE / INJECTIONAP2024-12-19a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A218644-003CYCLOPHOSPHAMIDE2GM/VIALINJECTABLE / INJECTIONAP2024-12-19a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A218644-001AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A218644-002AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A218644-003AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A218644-001AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A218644-002AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A218644-003AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08A218644-001AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A218644-002AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A218644-003AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A218644-001AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A218644-002AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A218644-003AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A218644-001AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A218644-002AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A218644-003AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A218644-001AP103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A218644-002AP103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A218644-003AP103ed91905a0d…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A218644-001AP1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A218644-002AP1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A218644-003AP1a50c72e98297…

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
1de02105-9c5b-4d11-bddf-bf8450d88b78Available 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
83634-206-51Cyclophosphamide1 in 1 CARTONINJECTION, POWDER, FOR SOLUTION11
83634-206-51Cyclophosphamide50 mL in 1 VIAL, SINGLE-DOSEINJECTION, POWDER, FOR SOLUTION501

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 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CyclophosphamideCYCLOPHOSPHAMIDEBluePoint Laboratories1d3396d8-4c03-4a28-890a-d87c6c53a74e2026-03-12Warnings, Adverse reactionsExact identifier
application applno (ANDA): 218644
application number: ANDA218644
CyclophosphamideCYCLOPHOSPHAMIDEAvenacy, LLC1de02105-9c5b-4d11-bddf-bf8450d88b782026-02-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 218644
application number: ANDA218644
ndc (product): 83634-206
CyclophosphamideCYCLOPHOSPHAMIDEEpic Pharma, LLC988d2f71-1dc7-45b5-b2df-187e682249732025-11-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 218644
application number: ANDA218644

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1734919cycloPHOSphamide 1 GM InjectionPSN1de02105-9c5b-4d11-bddf-bf8450d88b781
1734921cycloPHOSphamide 2 GM InjectionPSN1de02105-9c5b-4d11-bddf-bf8450d88b781
1734917cycloPHOSphamide 500 MG InjectionPSN1de02105-9c5b-4d11-bddf-bf8450d88b781
1734919cyclophosphamide 1000 MG InjectionSCD1de02105-9c5b-4d11-bddf-bf8450d88b781
1734921cyclophosphamide 2000 MG InjectionSCD1de02105-9c5b-4d11-bddf-bf8450d88b781
1734917cyclophosphamide 500 MG InjectionSCD1de02105-9c5b-4d11-bddf-bf8450d88b781
1734919cyclophosphamide (as cyclophosphamide monohydrate) 1000 MG InjectionSY1de02105-9c5b-4d11-bddf-bf8450d88b781
1734921cyclophosphamide (as cyclophosphamide monohydrate) 2000 MG InjectionSY1de02105-9c5b-4d11-bddf-bf8450d88b781
1734917cyclophosphamide (as cyclophosphamide monohydrate) 500 MG InjectionSY1de02105-9c5b-4d11-bddf-bf8450d88b781
1734919cyclophosphamide 1 GM InjectionSY1de02105-9c5b-4d11-bddf-bf8450d88b781
1734921cyclophosphamide 2 GM InjectionSY1de02105-9c5b-4d11-bddf-bf8450d88b781

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
83634-206-51836340206511 VIAL, SINGLE-DOSE in 1 CARTON (83634-206-51) / 50 mL in 1 VIAL, SINGLE-DOSE2026-02-01NoNoCurrent