FDA.reportPublic FDA data

Cyclophosphamide

Product NDC
16714-859
11-digit product format
167140859
Labeler code
16714
Product ID
16714-859_27e82150-4ad3-5be6-e063-6394a90a0e3f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
cyclophosphamide
Dosage form
INJECTION, POWDER, FOR SOLUTION
Route
INTRAVENOUS; ORAL
Labeler
NorthStar Rx LLC
Application
ANDA204555
Marketing category
ANDA
Marketing start
2019-01-08
Substance
CYCLOPHOSPHAMIDE
Active strength
500 mg/25mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CYCLOPHOSPHAMIDE500 mg/25mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii8N3DW7272P
Rxcui1734917, 1734919, 1734921

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
16714-859-012021-08-03C16284748780-1c7ccaba7-1b42-fd44-e053-dadaa90aa01bThese highlights do not include all the information needed to use CYCLOPHOSPHAMIDE safely and effectively. See full prescribing information for CYCLOPHOSPHAMIDE . CYCLOPHOSPHAMIDE injection, for intravenous use Initial U.S. Approval: 1959
16714-859-012021-07-23C16284748780-1c7ccaba7-1b42-fd44-e053-dadaa90aa01bThese highlights do not include all the information needed to use CYCLOPHOSPHAMIDE safely and effectively. See full prescribing information for CYCLOPHOSPHAMIDE . CYCLOPHOSPHAMIDE injection, for intravenous use Initial U.S. Approval: 1959

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
16714-859-01Cyclophosphamide1 in 1 CARTONINJECTION, POWDER, FOR SOLUTION19
16714-859-01Cyclophosphamide25 mL in 1 VIAL, SINGLE-DOSEINJECTION, POWDER, FOR SOLUTION259

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16714-859-01EA - Each16714-859a7f57e02-7821-4372-927d-dafdad85f83212019-04-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16714-859CYCLOPHOSPHAMIDE INJECTION, POWDER, FOR SOLUTION [NORTHSTAR RX LLC]9Current NDC, Legacy NDC, 2 package rows20241129_76f057be-e3da-0a89-e053-2a91aa0a8438.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1734919cycloPHOSphamide 1 GM InjectionPSN76f057be-e3da-0a89-e053-2a91aa0a84389
1734921cycloPHOSphamide 2 GM InjectionPSN76f057be-e3da-0a89-e053-2a91aa0a84389
1734917cycloPHOSphamide 500 MG InjectionPSN76f057be-e3da-0a89-e053-2a91aa0a84389
1734919cyclophosphamide 1000 MG InjectionSCD76f057be-e3da-0a89-e053-2a91aa0a84389
1734921cyclophosphamide 2000 MG InjectionSCD76f057be-e3da-0a89-e053-2a91aa0a84389
1734917cyclophosphamide 500 MG InjectionSCD76f057be-e3da-0a89-e053-2a91aa0a84389
1734919cyclophosphamide (as cyclophosphamide monohydrate) 1000 MG InjectionSY76f057be-e3da-0a89-e053-2a91aa0a84389
1734921cyclophosphamide (as cyclophosphamide monohydrate) 2000 MG InjectionSY76f057be-e3da-0a89-e053-2a91aa0a84389
1734917cyclophosphamide (as cyclophosphamide monohydrate) 500 MG InjectionSY76f057be-e3da-0a89-e053-2a91aa0a84389
1734919cyclophosphamide 1 GM InjectionSY76f057be-e3da-0a89-e053-2a91aa0a84389
1734921cyclophosphamide 2 GM InjectionSY76f057be-e3da-0a89-e053-2a91aa0a84389

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
16714-859-01167140859011 VIAL, SINGLE-DOSE in 1 CARTON (16714-859-01) / 25 mL in 1 VIAL, SINGLE-DOSE2019-01-080000-00-00NoNoCurrent