Cyclophosphamide

Product NDC
72603-326
Requested package NDC
72603-326-01
11-digit product format
726030326
Labeler code
72603
Product ID
72603-326_2eac820a-3535-4167-9a24-11f42ec961ef
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
2026-05-31
Substance
CYCLOPHOSPHAMIDE
Active strength
1 g/50mL
NDC exclude flag
No
Current FDA listing
Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage72603-32672603-326-01DDiscontinued by firm2026-08-17

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
A210046-001CYCLOPHOSPHAMIDECYCLOPHOSPHAMIDE500MG/VIALINJECTABLE / INJECTIONAP2018-05-25
A210046-002CYCLOPHOSPHAMIDECYCLOPHOSPHAMIDE1GM/VIALINJECTABLE / INJECTIONAP2018-05-25
A210046-003CYCLOPHOSPHAMIDECYCLOPHOSPHAMIDE2GM/VIALINJECTABLE / INJECTIONAP2018-05-25

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A210046-001AP
A210046-002AP
A210046-003AP

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.

Product history page 1 of 4 · 126 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A210046-001CYCLOPHOSPHAMIDE500MG/VIALINJECTABLE / INJECTIONAP2018-05-25caaa826d4ba7…
2026-08-18 06:07:402026-07A210046-002CYCLOPHOSPHAMIDE1GM/VIALINJECTABLE / INJECTIONAP2018-05-25caaa826d4ba7…
2026-08-18 06:07:402026-07A210046-003CYCLOPHOSPHAMIDE2GM/VIALINJECTABLE / INJECTIONAP2018-05-25caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A210046-001CYCLOPHOSPHAMIDE500MG/VIALINJECTABLE / INJECTIONAP2018-05-25011fe1cb6892…
2026-02-19 14:30 UTC2026-02A210046-002CYCLOPHOSPHAMIDE1GM/VIALINJECTABLE / INJECTIONAP2018-05-25011fe1cb6892…
2026-02-19 14:30 UTC2026-02A210046-003CYCLOPHOSPHAMIDE2GM/VIALINJECTABLE / INJECTIONAP2018-05-25011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210046-001CYCLOPHOSPHAMIDE500MG/VIALINJECTABLE / INJECTIONAP2018-05-2531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210046-002CYCLOPHOSPHAMIDE1GM/VIALINJECTABLE / INJECTIONAP2018-05-2531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210046-003CYCLOPHOSPHAMIDE2GM/VIALINJECTABLE / INJECTIONAP2018-05-2531067a03dcf5…
2025-08-23 18:47 UTC2025-08A210046-001CYCLOPHOSPHAMIDE500MG/VIALINJECTABLE / INJECTIONAP2018-05-256a471c1ec25d…
2025-08-23 18:47 UTC2025-08A210046-002CYCLOPHOSPHAMIDE1GM/VIALINJECTABLE / INJECTIONAP2018-05-256a471c1ec25d…
2025-08-23 18:47 UTC2025-08A210046-003CYCLOPHOSPHAMIDE2GM/VIALINJECTABLE / INJECTIONAP2018-05-256a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210046-001CYCLOPHOSPHAMIDE500MG/VIALINJECTABLE / INJECTIONAP2018-05-25fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210046-002CYCLOPHOSPHAMIDE1GM/VIALINJECTABLE / INJECTIONAP2018-05-25fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210046-003CYCLOPHOSPHAMIDE2GM/VIALINJECTABLE / INJECTIONAP2018-05-25fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210046-001CYCLOPHOSPHAMIDE500MG/VIALINJECTABLE / INJECTIONAP2018-05-25b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210046-002CYCLOPHOSPHAMIDE1GM/VIALINJECTABLE / INJECTIONAP2018-05-25b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210046-003CYCLOPHOSPHAMIDE2GM/VIALINJECTABLE / INJECTIONAP2018-05-25b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210046-001CYCLOPHOSPHAMIDE500MG/VIALINJECTABLE / INJECTIONAP2018-05-2503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210046-002CYCLOPHOSPHAMIDE1GM/VIALINJECTABLE / INJECTIONAP2018-05-2503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210046-003CYCLOPHOSPHAMIDE2GM/VIALINJECTABLE / INJECTIONAP2018-05-2503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210046-001CYCLOPHOSPHAMIDE500MG/VIALINJECTABLE / INJECTIONAP2018-05-252680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210046-002CYCLOPHOSPHAMIDE1GM/VIALINJECTABLE / INJECTIONAP2018-05-252680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210046-003CYCLOPHOSPHAMIDE2GM/VIALINJECTABLE / INJECTIONAP2018-05-252680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210046-001CYCLOPHOSPHAMIDE500MG/VIALINJECTABLE / INJECTIONAP2018-05-255bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210046-002CYCLOPHOSPHAMIDE1GM/VIALINJECTABLE / INJECTIONAP2018-05-255bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210046-003CYCLOPHOSPHAMIDE2GM/VIALINJECTABLE / INJECTIONAP2018-05-255bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A210046-001CYCLOPHOSPHAMIDE500MG/VIALINJECTABLE / INJECTIONAP2018-05-25d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A210046-002CYCLOPHOSPHAMIDE1GM/VIALINJECTABLE / INJECTIONAP2018-05-25d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A210046-003CYCLOPHOSPHAMIDE2GM/VIALINJECTABLE / INJECTIONAP2018-05-25d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A210046-001CYCLOPHOSPHAMIDE500MG/VIALINJECTABLE / INJECTIONAP2018-05-25d06236e962d9…
2024-10-29 15:01 UTC2024-10A210046-002CYCLOPHOSPHAMIDE1GM/VIALINJECTABLE / INJECTIONAP2018-05-25d06236e962d9…
2024-10-29 15:01 UTC2024-10A210046-003CYCLOPHOSPHAMIDE2GM/VIALINJECTABLE / INJECTIONAP2018-05-25d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A210046-001CYCLOPHOSPHAMIDE500MG/VIALINJECTABLE / INJECTIONAP2018-05-2579d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A210046-002CYCLOPHOSPHAMIDE1GM/VIALINJECTABLE / INJECTIONAP2018-05-2579d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A210046-003CYCLOPHOSPHAMIDE2GM/VIALINJECTABLE / INJECTIONAP2018-05-2579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A210046-001CYCLOPHOSPHAMIDE500MG/VIALINJECTABLE / INJECTIONAP2018-05-25301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A210046-002CYCLOPHOSPHAMIDE1GM/VIALINJECTABLE / INJECTIONAP2018-05-25301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A210046-003CYCLOPHOSPHAMIDE2GM/VIALINJECTABLE / INJECTIONAP2018-05-25301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A210046-001CYCLOPHOSPHAMIDE500MG/VIALINJECTABLE / INJECTIONAP2018-05-251e350fbaab3a…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 126 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A210046-001AP1caaa826d4ba7…
2026-08-18 06:07:402026-07A210046-002AP1caaa826d4ba7…
2026-08-18 06:07:402026-07A210046-003AP1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A210046-001AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A210046-002AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A210046-003AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210046-001AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210046-002AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210046-003AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08A210046-001AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A210046-002AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A210046-003AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210046-001AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210046-002AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210046-003AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210046-001AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210046-002AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210046-003AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210046-001AP103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210046-002AP103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210046-003AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210046-001AP12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210046-002AP12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210046-003AP12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210046-001AP15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210046-002AP15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210046-003AP15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A210046-001AP1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A210046-002AP1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A210046-003AP1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A210046-001AP1d06236e962d9…
2024-10-29 15:01 UTC2024-10A210046-002AP1d06236e962d9…
2024-10-29 15:01 UTC2024-10A210046-003AP1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A210046-001AP179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A210046-002AP179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A210046-003AP179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A210046-001AP1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A210046-002AP1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A210046-003AP1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A210046-001AP11e350fbaab3a…

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
72603-326-01Cyclophosphamide50 mL in 1 VIAL, SINGLE-DOSEINJECTION, POWDER, FOR SOLUTION509
72603-326-01Cyclophosphamide1 in 1 CARTONINJECTION, POWDER, FOR SOLUTION19

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72603-326-01EA - Each72603-3265247dd21-082b-42bf-8577-a269b72d46a212020-06-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72603-326CYCLOPHOSPHAMIDE INJECTION, POWDER, FOR SOLUTION [NORTHSTAR RXLLC]7Current NDC, Legacy NDC, 2 package rows20241224_fdaa7d15-7c06-44ab-b1d5-9d2b3e8ffd28.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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CyclophosphamideCYCLOPHOSPHAMIDEAmneal Pharmaceuticals LLC520bfe39-dfd5-4a20-9a37-80078afded0d2026-01-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210046
application number: ANDA210046

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
72603-326-01726030326011 VIAL, SINGLE-DOSE in 1 CARTON (72603-326-01) / 50 mL in 1 VIAL, SINGLE-DOSE2019-05-102026-05-31NoNoCurrent