CARBOPLATIN

Product NDC
69097-242
11-digit product format
690970242
Labeler code
69097
Product ID
69097-242_819cc4ff-98c7-4664-911f-b87e00340e78
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
CARBOPLATIN
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Cipla USA Inc.
Application
ANDA077861
Marketing category
ANDA
Marketing start
2007-01-18
Marketing end
0000-00-00
Substance
CARBOPLATIN
Active strength
450 mg/45mL
Pharmacologic classes
Platinum-containing Compounds [EXT],Platinum-based Drug [EPC]
NDC exclude flag
No
Listing certified through
2019-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct69097-242DDiscontinued by firm2026-08-17
excluded packagepackage69097-24269097-242-41DDiscontinued 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 · 42 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 packagepackage69097-242-41d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage69097-242-41f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage69097-242-412ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage69097-242-41a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage69097-242-41cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage69097-242-41cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage69097-242-41302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage69097-242-41ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage69097-242-410efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage69097-242-41ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage69097-242-41367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage69097-242-41557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage69097-242-418af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage69097-242-41834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage69097-242-411332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage69097-242-41fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage69097-242-4186f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage69097-242-41bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage69097-242-418dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage69097-242-41e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage69097-242-419bebd1f3094a…5416666fcb17…

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
A077861-001CARBOPLATINCARBOPLATIN50MG/5ML (10MG/ML)INJECTABLE / INTRAVENOUSAP2007-01-18
A077861-002CARBOPLATINCARBOPLATIN150MG/15ML (10MG/ML)INJECTABLE / INTRAVENOUSAP2007-01-18
A077861-003CARBOPLATINCARBOPLATIN450MG/45ML (10MG/ML)INJECTABLE / INTRAVENOUSAP2007-01-18
A077861-004CARBOPLATINCARBOPLATIN600MG/60ML (10MG/ML)INJECTABLE / INTRAVENOUSAP2007-01-18

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-productTE code
A077861-001AP
A077861-002AP
A077861-003AP
A077861-004AP

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 06:07:402026-07A077861-001CARBOPLATIN50MG/5ML (10MG/ML)INJECTABLE / INTRAVENOUSAP2007-01-18caaa826d4ba7…
2026-08-18 06:07:402026-07A077861-002CARBOPLATIN150MG/15ML (10MG/ML)INJECTABLE / INTRAVENOUSAP2007-01-18caaa826d4ba7…
2026-08-18 06:07:402026-07A077861-003CARBOPLATIN450MG/45ML (10MG/ML)INJECTABLE / INTRAVENOUSAP2007-01-18caaa826d4ba7…
2026-08-18 06:07:402026-07A077861-004CARBOPLATIN600MG/60ML (10MG/ML)INJECTABLE / INTRAVENOUSAP2007-01-18caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A077861-001CARBOPLATIN50MG/5ML (10MG/ML)INJECTABLE / INTRAVENOUSAP2007-01-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077861-002CARBOPLATIN150MG/15ML (10MG/ML)INJECTABLE / INTRAVENOUSAP2007-01-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077861-003CARBOPLATIN450MG/45ML (10MG/ML)INJECTABLE / INTRAVENOUSAP2007-01-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077861-004CARBOPLATIN600MG/60ML (10MG/ML)INJECTABLE / INTRAVENOUSAP2007-01-18011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077861-001CARBOPLATIN50MG/5ML (10MG/ML)INJECTABLE / INTRAVENOUSAP2007-01-1831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077861-002CARBOPLATIN150MG/15ML (10MG/ML)INJECTABLE / INTRAVENOUSAP2007-01-1831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077861-003CARBOPLATIN450MG/45ML (10MG/ML)INJECTABLE / INTRAVENOUSAP2007-01-1831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077861-004CARBOPLATIN600MG/60ML (10MG/ML)INJECTABLE / INTRAVENOUSAP2007-01-1831067a03dcf5…
2025-08-23 18:47 UTC2025-08A077861-001CARBOPLATIN50MG/5ML (10MG/ML)INJECTABLE / INTRAVENOUSAP2007-01-186a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077861-002CARBOPLATIN150MG/15ML (10MG/ML)INJECTABLE / INTRAVENOUSAP2007-01-186a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077861-003CARBOPLATIN450MG/45ML (10MG/ML)INJECTABLE / INTRAVENOUSAP2007-01-186a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077861-004CARBOPLATIN600MG/60ML (10MG/ML)INJECTABLE / INTRAVENOUSAP2007-01-186a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077861-001CARBOPLATIN50MG/5ML (10MG/ML)INJECTABLE / INTRAVENOUSAP2007-01-18fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077861-002CARBOPLATIN150MG/15ML (10MG/ML)INJECTABLE / INTRAVENOUSAP2007-01-18fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077861-003CARBOPLATIN450MG/45ML (10MG/ML)INJECTABLE / INTRAVENOUSAP2007-01-18fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077861-004CARBOPLATIN600MG/60ML (10MG/ML)INJECTABLE / INTRAVENOUSAP2007-01-18fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077861-001CARBOPLATIN50MG/5ML (10MG/ML)INJECTABLE / INTRAVENOUSAP2007-01-18b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077861-002CARBOPLATIN150MG/15ML (10MG/ML)INJECTABLE / INTRAVENOUSAP2007-01-18b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077861-003CARBOPLATIN450MG/45ML (10MG/ML)INJECTABLE / INTRAVENOUSAP2007-01-18b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077861-004CARBOPLATIN600MG/60ML (10MG/ML)INJECTABLE / INTRAVENOUSAP2007-01-18b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077861-001CARBOPLATIN50MG/5ML (10MG/ML)INJECTABLE / INTRAVENOUSAP2007-01-1803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077861-002CARBOPLATIN150MG/15ML (10MG/ML)INJECTABLE / INTRAVENOUSAP2007-01-1803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077861-003CARBOPLATIN450MG/45ML (10MG/ML)INJECTABLE / INTRAVENOUSAP2007-01-1803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077861-004CARBOPLATIN600MG/60ML (10MG/ML)INJECTABLE / INTRAVENOUSAP2007-01-1803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077861-001CARBOPLATIN50MG/5ML (10MG/ML)INJECTABLE / INTRAVENOUSAP2007-01-182680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077861-002CARBOPLATIN150MG/15ML (10MG/ML)INJECTABLE / INTRAVENOUSAP2007-01-182680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077861-003CARBOPLATIN450MG/45ML (10MG/ML)INJECTABLE / INTRAVENOUSAP2007-01-182680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077861-004CARBOPLATIN600MG/60ML (10MG/ML)INJECTABLE / INTRAVENOUSAP2007-01-182680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077861-001CARBOPLATIN50MG/5ML (10MG/ML)INJECTABLE / INTRAVENOUSAP2007-01-185bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077861-002CARBOPLATIN150MG/15ML (10MG/ML)INJECTABLE / INTRAVENOUSAP2007-01-185bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077861-003CARBOPLATIN450MG/45ML (10MG/ML)INJECTABLE / INTRAVENOUSAP2007-01-185bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077861-004CARBOPLATIN600MG/60ML (10MG/ML)INJECTABLE / INTRAVENOUSAP2007-01-185bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077861-001CARBOPLATIN50MG/5ML (10MG/ML)INJECTABLE / INTRAVENOUSAP2007-01-18d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077861-002CARBOPLATIN150MG/15ML (10MG/ML)INJECTABLE / INTRAVENOUSAP2007-01-18d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077861-003CARBOPLATIN450MG/45ML (10MG/ML)INJECTABLE / INTRAVENOUSAP2007-01-18d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077861-004CARBOPLATIN600MG/60ML (10MG/ML)INJECTABLE / INTRAVENOUSAP2007-01-18d8e5a09893c0…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 168 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A077861-001AP1caaa826d4ba7…
2026-08-18 06:07:402026-07A077861-002AP1caaa826d4ba7…
2026-08-18 06:07:402026-07A077861-003AP1caaa826d4ba7…
2026-08-18 06:07:402026-07A077861-004AP1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A077861-001AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077861-002AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077861-003AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077861-004AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077861-001AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077861-002AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077861-003AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077861-004AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08A077861-001AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077861-002AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077861-003AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077861-004AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077861-001AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077861-002AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077861-003AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077861-004AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077861-001AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077861-002AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077861-003AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077861-004AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077861-001AP103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077861-002AP103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077861-003AP103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077861-004AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077861-001AP12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077861-002AP12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077861-003AP12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077861-004AP12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077861-001AP15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077861-002AP15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077861-003AP15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077861-004AP15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077861-001AP1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077861-002AP1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077861-003AP1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077861-004AP1d8e5a09893c0…

FDA-Initiated Inactive NDC Indexing#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69097-242CARBOPLATIN INJECTION, SOLUTION [CIPLA USA INC.]2Legacy NDC20181217_e849cc58-64a1-4a6a-9e21-4c9a468eb5b9.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 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CARBOPLATINCARBOPLATINNatco Pharma USA LLC4c89cedc-e48b-445c-ad05-54dbe60e4fb02026-07-21Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077861
application number: ANDA077861
CARBOPLATINCARBOPLATINTeyro Labs Private Limitedf64a0cbe-7fe3-407e-8933-21c30e1a1ebc2025-01-08Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077861
application number: ANDA077861
CARBOPLATINCARBOPLATINApotex Corp.1c275825-0275-4c73-b650-e4c1519f13b82024-01-07Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077861
application number: ANDA077861