FDA.reportPublic FDA data

Carboplatin

Product NDC
50742-447
11-digit product format
507420447
Labeler code
50742
Product ID
50742-447_0ebb7c94-5fbc-4f56-84a3-b061a6652ce2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Carboplatin
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Ingenus Pharmaceuticals, LLC
Application
ANDA208487
Marketing category
ANDA
Marketing start
2017-05-06
Marketing end
2021-12-31
Substance
CARBOPLATIN
Active strength
450 mg/45mL
Pharmacologic classes
Platinum-containing Compounds [EXT],Platinum-based Drug [EPC]
NDC exclude flag
No
Listing certified through
0000-00-00
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 productproduct50742-447DDiscontinued by firm2026-08-10
excluded packagepackage50742-44750742-447-45DDiscontinued by firm2026-08-10

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A208487-001CARBOPLATINCARBOPLATIN50MG/5ML (10MG/ML)INJECTABLE / INTRAVENOUS2017-04-26
A208487-002CARBOPLATINCARBOPLATIN150MG/15ML (10MG/ML)INJECTABLE / INTRAVENOUS2017-04-26
A208487-003CARBOPLATINCARBOPLATIN450MG/45ML (10MG/ML)INJECTABLE / INTRAVENOUS2017-04-26
A208487-004CARBOPLATINCARBOPLATIN600MG/60ML (10MG/ML)INJECTABLE / INTRAVENOUS2017-04-26

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 · 164 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A208487-001CARBOPLATIN50MG/5ML (10MG/ML)INJECTABLE / INTRAVENOUSAP2017-04-26011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208487-002CARBOPLATIN150MG/15ML (10MG/ML)INJECTABLE / INTRAVENOUSAP2017-04-26011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208487-003CARBOPLATIN450MG/45ML (10MG/ML)INJECTABLE / INTRAVENOUSAP2017-04-26011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208487-004CARBOPLATIN600MG/60ML (10MG/ML)INJECTABLE / INTRAVENOUSAP2017-04-26011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208487-001CARBOPLATIN50MG/5ML (10MG/ML)INJECTABLE / INTRAVENOUSAP2017-04-2631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208487-002CARBOPLATIN150MG/15ML (10MG/ML)INJECTABLE / INTRAVENOUSAP2017-04-2631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208487-003CARBOPLATIN450MG/45ML (10MG/ML)INJECTABLE / INTRAVENOUSAP2017-04-2631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208487-004CARBOPLATIN600MG/60ML (10MG/ML)INJECTABLE / INTRAVENOUSAP2017-04-2631067a03dcf5…
2025-08-23 18:47 UTC2025-08A208487-001CARBOPLATIN50MG/5ML (10MG/ML)INJECTABLE / INTRAVENOUSAP2017-04-266a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208487-002CARBOPLATIN150MG/15ML (10MG/ML)INJECTABLE / INTRAVENOUSAP2017-04-266a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208487-003CARBOPLATIN450MG/45ML (10MG/ML)INJECTABLE / INTRAVENOUSAP2017-04-266a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208487-004CARBOPLATIN600MG/60ML (10MG/ML)INJECTABLE / INTRAVENOUSAP2017-04-266a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208487-001CARBOPLATIN50MG/5ML (10MG/ML)INJECTABLE / INTRAVENOUSAP2017-04-26fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208487-002CARBOPLATIN150MG/15ML (10MG/ML)INJECTABLE / INTRAVENOUSAP2017-04-26fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208487-003CARBOPLATIN450MG/45ML (10MG/ML)INJECTABLE / INTRAVENOUSAP2017-04-26fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208487-004CARBOPLATIN600MG/60ML (10MG/ML)INJECTABLE / INTRAVENOUSAP2017-04-26fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208487-001CARBOPLATIN50MG/5ML (10MG/ML)INJECTABLE / INTRAVENOUSAP2017-04-26b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208487-002CARBOPLATIN150MG/15ML (10MG/ML)INJECTABLE / INTRAVENOUSAP2017-04-26b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208487-003CARBOPLATIN450MG/45ML (10MG/ML)INJECTABLE / INTRAVENOUSAP2017-04-26b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208487-004CARBOPLATIN600MG/60ML (10MG/ML)INJECTABLE / INTRAVENOUSAP2017-04-26b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208487-001CARBOPLATIN50MG/5ML (10MG/ML)INJECTABLE / INTRAVENOUSAP2017-04-2603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208487-002CARBOPLATIN150MG/15ML (10MG/ML)INJECTABLE / INTRAVENOUSAP2017-04-2603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208487-003CARBOPLATIN450MG/45ML (10MG/ML)INJECTABLE / INTRAVENOUSAP2017-04-2603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208487-004CARBOPLATIN600MG/60ML (10MG/ML)INJECTABLE / INTRAVENOUSAP2017-04-2603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208487-001CARBOPLATIN50MG/5ML (10MG/ML)INJECTABLE / INTRAVENOUSAP2017-04-262680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208487-002CARBOPLATIN150MG/15ML (10MG/ML)INJECTABLE / INTRAVENOUSAP2017-04-262680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208487-003CARBOPLATIN450MG/45ML (10MG/ML)INJECTABLE / INTRAVENOUSAP2017-04-262680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208487-004CARBOPLATIN600MG/60ML (10MG/ML)INJECTABLE / INTRAVENOUSAP2017-04-262680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208487-001CARBOPLATIN50MG/5ML (10MG/ML)INJECTABLE / INTRAVENOUSAP2017-04-265bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208487-002CARBOPLATIN150MG/15ML (10MG/ML)INJECTABLE / INTRAVENOUSAP2017-04-265bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208487-003CARBOPLATIN450MG/45ML (10MG/ML)INJECTABLE / INTRAVENOUSAP2017-04-265bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208487-004CARBOPLATIN600MG/60ML (10MG/ML)INJECTABLE / INTRAVENOUSAP2017-04-265bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A208487-001CARBOPLATIN50MG/5ML (10MG/ML)INJECTABLE / INTRAVENOUSAP2017-04-26d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A208487-002CARBOPLATIN150MG/15ML (10MG/ML)INJECTABLE / INTRAVENOUSAP2017-04-26d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A208487-003CARBOPLATIN450MG/45ML (10MG/ML)INJECTABLE / INTRAVENOUSAP2017-04-26d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A208487-004CARBOPLATIN600MG/60ML (10MG/ML)INJECTABLE / INTRAVENOUSAP2017-04-26d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A208487-001CARBOPLATIN50MG/5ML (10MG/ML)INJECTABLE / INTRAVENOUSAP2017-04-26d06236e962d9…
2024-10-29 15:01 UTC2024-10A208487-002CARBOPLATIN150MG/15ML (10MG/ML)INJECTABLE / INTRAVENOUSAP2017-04-26d06236e962d9…
2024-10-29 15:01 UTC2024-10A208487-003CARBOPLATIN450MG/45ML (10MG/ML)INJECTABLE / INTRAVENOUSAP2017-04-26d06236e962d9…
2024-10-29 15:01 UTC2024-10A208487-004CARBOPLATIN600MG/60ML (10MG/ML)INJECTABLE / INTRAVENOUSAP2017-04-26d06236e962d9…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 140 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A208487-001AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208487-002AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208487-003AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208487-004AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208487-001AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208487-002AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208487-003AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208487-004AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08A208487-001AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208487-002AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208487-003AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208487-004AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208487-001AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208487-002AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208487-003AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208487-004AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208487-001AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208487-002AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208487-003AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208487-004AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208487-001AP103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208487-002AP103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208487-003AP103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208487-004AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208487-001AP12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208487-002AP12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208487-003AP12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208487-004AP12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208487-001AP15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208487-002AP15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208487-003AP15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208487-004AP15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A208487-001AP1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A208487-002AP1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A208487-003AP1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A208487-004AP1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A208487-001AP1d06236e962d9…
2024-10-29 15:01 UTC2024-10A208487-002AP1d06236e962d9…
2024-10-29 15:01 UTC2024-10A208487-003AP1d06236e962d9…
2024-10-29 15:01 UTC2024-10A208487-004AP1d06236e962d9…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50742-447-45ML - Milliliter50742-4475b94c51d-e764-4e6e-a249-b25f4f1d384012018-02-20

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50742-447CARBOPLATIN INJECTION, SOLUTION [INGENUS PHARMACEUTICALS, LLC]10Legacy NDC20230713_475caee0-15a6-4f0d-bca7-f3e472b323f7.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50742-447-45507420447451 VIAL, MULTI-DOSE in 1 CARTON (50742-447-45) > 45 mL in 1 VIAL, MULTI-DOSE2017-05-062021-12-31NoNoCurrent