Cyclophosphamide

Product NDC
72603-104
11-digit product format
726030104
Labeler code
72603
Product ID
72603-104_c6393605-d890-4336-9907-350442ec3a63
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cyclophosphamide
Dosage form
INJECTION, POWDER, FOR SOLUTION
Route
INTRAVENOUS; ORAL
Labeler
NorthStar RxLLC
Application
ANDA210046
Marketing category
ANDA
Marketing start
2019-05-10
Marketing end
0000-00-00
Substance
CYCLOPHOSPHAMIDE
Active strength
500 mg/25mL
Pharmacologic classes
Alkylating Activity [MoA], Alkylating Drug [EPC]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

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
72603-104-01Cyclophosphamide1 in 1 CARTONINJECTION, POWDER, FOR SOLUTION19
72603-104-01Cyclophosphamide25 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
72603-104-01EA - Each72603-1044bfce478-23b0-401b-8f3c-4bb7d41a27fe12020-06-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72603-104CYCLOPHOSPHAMIDE INJECTION, POWDER, FOR SOLUTION [NORTHSTAR RXLLC]7Legacy NDC, 2 package rows20241224_fdaa7d15-7c06-44ab-b1d5-9d2b3e8ffd28.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
72603-104-01726030104011 VIAL, SINGLE-DOSE in 1 CARTON (72603-104-01) > 25 mL in 1 VIAL, SINGLE-DOSE2019-05-100000-00-00NoNoCurrent