Carboplatin

Product NDC
25021-202
11-digit product format
250210202
Labeler code
25021
Product ID
25021-202_841aacb3-4b35-4db3-beaf-a4b22c8a8981
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
carboplatin
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Sagent Pharmaceuticals
Application
ANDA077096
Marketing category
ANDA
Marketing start
2013-10-31
Marketing end
0000-00-00
Substance
CARBOPLATIN
Active strength
10 mg/mL
Pharmacologic classes
Platinum-containing Compounds [EXT],Platinum-based Drug [EPC]
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

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 · 5 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct25021-202DDiscontinued by firm2026-08-17
excluded packagepackage25021-20225021-202-05DDiscontinued by firm2026-08-17
excluded packagepackage25021-20225021-202-15DDiscontinued by firm2026-08-17
excluded packagepackage25021-20225021-202-45DDiscontinued by firm2026-08-17
excluded packagepackage25021-20225021-202-51DDiscontinued by firm2026-08-17

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 60 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage25021-202-51d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage25021-202-15d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage25021-202-45d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage25021-202-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage25021-202-51f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage25021-202-15f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage25021-202-45f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage25021-202-05f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage25021-202-512ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage25021-202-152ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage25021-202-452ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage25021-202-052ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage25021-202-51a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage25021-202-15a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage25021-202-45a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage25021-202-05a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage25021-202-51cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage25021-202-15cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage25021-202-45cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage25021-202-05cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage25021-202-51cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage25021-202-15cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage25021-202-45cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage25021-202-05cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage25021-202-51302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage25021-202-15302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage25021-202-45302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage25021-202-05302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage25021-202-51ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage25021-202-15ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage25021-202-45ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage25021-202-05ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage25021-202-510efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage25021-202-150efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage25021-202-450efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage25021-202-050efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage25021-202-51ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage25021-202-15ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage25021-202-45ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage25021-202-05ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage25021-202-51367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage25021-202-15367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage25021-202-45367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage25021-202-05367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage25021-202-51557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage25021-202-15557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage25021-202-45557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage25021-202-05557ba5c1ecfa…9c80585c8c6e…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A077096-001CARBOPLATINCARBOPLATIN50MG/5ML (10MG/ML)INJECTABLE / INTRAVENOUS2005-06-14
A077096-002CARBOPLATINCARBOPLATIN150MG/15ML (10MG/ML)INJECTABLE / INTRAVENOUS2005-06-14
A077096-003CARBOPLATINCARBOPLATIN450MG/45ML (10MG/ML)INJECTABLE / INTRAVENOUS2005-06-14
A077096-004CARBOPLATINCARBOPLATIN600MG/60ML (10MG/ML)INJECTABLE / INTRAVENOUS2013-06-03

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 5 · 168 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A077096-001CARBOPLATIN50MG/5ML (10MG/ML)INJECTABLE / INTRAVENOUS2005-06-14caaa826d4ba7…
2026-08-18 06:07:402026-07A077096-002CARBOPLATIN150MG/15ML (10MG/ML)INJECTABLE / INTRAVENOUS2005-06-14caaa826d4ba7…
2026-08-18 06:07:402026-07A077096-003CARBOPLATIN450MG/45ML (10MG/ML)INJECTABLE / INTRAVENOUS2005-06-14caaa826d4ba7…
2026-08-18 06:07:402026-07A077096-004CARBOPLATIN600MG/60ML (10MG/ML)INJECTABLE / INTRAVENOUS2013-06-03caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A077096-001CARBOPLATIN50MG/5ML (10MG/ML)INJECTABLE / INTRAVENOUS2005-06-14011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077096-002CARBOPLATIN150MG/15ML (10MG/ML)INJECTABLE / INTRAVENOUS2005-06-14011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077096-003CARBOPLATIN450MG/45ML (10MG/ML)INJECTABLE / INTRAVENOUS2005-06-14011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077096-004CARBOPLATIN600MG/60ML (10MG/ML)INJECTABLE / INTRAVENOUS2013-06-03011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077096-001CARBOPLATIN50MG/5ML (10MG/ML)INJECTABLE / INTRAVENOUS2005-06-1431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077096-002CARBOPLATIN150MG/15ML (10MG/ML)INJECTABLE / INTRAVENOUS2005-06-1431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077096-003CARBOPLATIN450MG/45ML (10MG/ML)INJECTABLE / INTRAVENOUS2005-06-1431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077096-004CARBOPLATIN600MG/60ML (10MG/ML)INJECTABLE / INTRAVENOUS2013-06-0331067a03dcf5…
2025-08-23 18:47 UTC2025-08A077096-001CARBOPLATIN50MG/5ML (10MG/ML)INJECTABLE / INTRAVENOUS2005-06-146a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077096-002CARBOPLATIN150MG/15ML (10MG/ML)INJECTABLE / INTRAVENOUS2005-06-146a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077096-003CARBOPLATIN450MG/45ML (10MG/ML)INJECTABLE / INTRAVENOUS2005-06-146a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077096-004CARBOPLATIN600MG/60ML (10MG/ML)INJECTABLE / INTRAVENOUS2013-06-036a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077096-001CARBOPLATIN50MG/5ML (10MG/ML)INJECTABLE / INTRAVENOUS2005-06-14fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077096-002CARBOPLATIN150MG/15ML (10MG/ML)INJECTABLE / INTRAVENOUS2005-06-14fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077096-003CARBOPLATIN450MG/45ML (10MG/ML)INJECTABLE / INTRAVENOUS2005-06-14fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077096-004CARBOPLATIN600MG/60ML (10MG/ML)INJECTABLE / INTRAVENOUS2013-06-03fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077096-001CARBOPLATIN50MG/5ML (10MG/ML)INJECTABLE / INTRAVENOUS2005-06-14b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077096-002CARBOPLATIN150MG/15ML (10MG/ML)INJECTABLE / INTRAVENOUS2005-06-14b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077096-003CARBOPLATIN450MG/45ML (10MG/ML)INJECTABLE / INTRAVENOUS2005-06-14b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077096-004CARBOPLATIN600MG/60ML (10MG/ML)INJECTABLE / INTRAVENOUS2013-06-03b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077096-001CARBOPLATIN50MG/5ML (10MG/ML)INJECTABLE / INTRAVENOUS2005-06-1403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077096-002CARBOPLATIN150MG/15ML (10MG/ML)INJECTABLE / INTRAVENOUS2005-06-1403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077096-003CARBOPLATIN450MG/45ML (10MG/ML)INJECTABLE / INTRAVENOUS2005-06-1403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077096-004CARBOPLATIN600MG/60ML (10MG/ML)INJECTABLE / INTRAVENOUS2013-06-0303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077096-001CARBOPLATIN50MG/5ML (10MG/ML)INJECTABLE / INTRAVENOUS2005-06-142680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077096-002CARBOPLATIN150MG/15ML (10MG/ML)INJECTABLE / INTRAVENOUS2005-06-142680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077096-003CARBOPLATIN450MG/45ML (10MG/ML)INJECTABLE / INTRAVENOUS2005-06-142680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077096-004CARBOPLATIN600MG/60ML (10MG/ML)INJECTABLE / INTRAVENOUS2013-06-032680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077096-001CARBOPLATIN50MG/5ML (10MG/ML)INJECTABLE / INTRAVENOUS2005-06-145bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077096-002CARBOPLATIN150MG/15ML (10MG/ML)INJECTABLE / INTRAVENOUS2005-06-145bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077096-003CARBOPLATIN450MG/45ML (10MG/ML)INJECTABLE / INTRAVENOUS2005-06-145bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077096-004CARBOPLATIN600MG/60ML (10MG/ML)INJECTABLE / INTRAVENOUS2013-06-035bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077096-001CARBOPLATIN50MG/5ML (10MG/ML)INJECTABLE / INTRAVENOUS2005-06-14d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077096-002CARBOPLATIN150MG/15ML (10MG/ML)INJECTABLE / INTRAVENOUS2005-06-14d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077096-003CARBOPLATIN450MG/45ML (10MG/ML)INJECTABLE / INTRAVENOUS2005-06-14d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077096-004CARBOPLATIN600MG/60ML (10MG/ML)INJECTABLE / INTRAVENOUS2013-06-03d8e5a09893c0…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2019-12-13 00:20 UTC2019-12A077096-001AP174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A077096-002AP174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A077096-003AP174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A077096-004AP174a2ff9319b5…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A077096-001AP187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A077096-002AP187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A077096-003AP187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A077096-004AP187673890dc5c…
2021-03-12 10:30 UTC2021-03A077096-001AP15aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03A077096-002AP15aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03A077096-003AP15aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03A077096-004AP15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A077096-001AP18869cabd3fbd…
2020-12-22 03:56 UTC2020-12A077096-002AP18869cabd3fbd…
2020-12-22 03:56 UTC2020-12A077096-003AP18869cabd3fbd…
2020-12-22 03:56 UTC2020-12A077096-004AP18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A077096-001AP1c0c555d07b60…
2020-11-12 02:37 UTC2020-11A077096-002AP1c0c555d07b60…
2020-11-12 02:37 UTC2020-11A077096-003AP1c0c555d07b60…
2020-11-12 02:37 UTC2020-11A077096-004AP1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A077096-001AP13f01610625f2…
2019-12-14 00:12 UTC2019-12A077096-002AP13f01610625f2…
2019-12-14 00:12 UTC2019-12A077096-003AP13f01610625f2…
2019-12-14 00:12 UTC2019-12A077096-004AP13f01610625f2…
2019-09-15 20:21 UTC2019-09A077096-001AP1b00525d2431f…
2019-09-15 20:21 UTC2019-09A077096-002AP1b00525d2431f…
2019-09-15 20:21 UTC2019-09A077096-003AP1b00525d2431f…
2019-09-15 20:21 UTC2019-09A077096-004AP1b00525d2431f…
2019-07-19 19:46 UTC2019-07A077096-001AP1ea99ee380514…
2019-07-19 19:46 UTC2019-07A077096-002AP1ea99ee380514…
2019-07-19 19:46 UTC2019-07A077096-003AP1ea99ee380514…
2019-07-19 19:46 UTC2019-07A077096-004AP1ea99ee380514…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
25021-202-05ML - Milliliter25021-2026049f8e6-ae77-4d69-ae03-d5800897bbbb12013-11-04
25021-202-15ML - Milliliter25021-202cdbb0d4f-753e-41a5-ab4b-4f21815774dc12013-11-04
25021-202-45ML - Milliliter25021-202fa81325f-d446-4c5f-968b-35db8b0da68c12013-11-04
25021-202-51ML - Milliliter25021-202d0731a3a-c424-4c42-b604-6c2c5598856e12013-11-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
carboplatinACTIVE INGREDIENTBG3F62OND5CARBOPLATIN INJECTION, SOLUTION [SAGENT PHARMACEUTICALS]6
carboplatinACTIVE MOIETYBG3F62OND5CARBOPLATIN INJECTION, SOLUTION [SAGENT PHARMACEUTICALS]6
waterINACTIVE INGREDIENT059QF0KO0RCARBOPLATIN INJECTION, SOLUTION [SAGENT PHARMACEUTICALS]6