CARBOPLATIN

Product NDC
69339-366
Requested package NDC
69339-366-45
11-digit product format
693390366
Labeler code
69339
Product ID
69339-366_4c89cedc-e48b-445c-ad05-54dbe60e4fb0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
CARBOPLATIN
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Natco Pharma USA LLC
Application
ANDA077861
Marketing category
ANDA
Marketing start
2026-07-02
Substance
CARBOPLATIN
Active strength
450 mg/45mL
Pharmacologic classes
Platinum-based Drug [EPC]; Platinum-containing Compounds [EXT]
Listing certified through
2027-12-31
Current FDA listing
Yes

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
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 · 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 UTC2026-02A077861-001CARBOPLATIN50MG/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…
2024-10-29 15:01 UTC2024-10A077861-001CARBOPLATIN50MG/5ML (10MG/ML)INJECTABLE / INTRAVENOUSAP2007-01-18d06236e962d9…
2024-10-29 15:01 UTC2024-10A077861-002CARBOPLATIN150MG/15ML (10MG/ML)INJECTABLE / INTRAVENOUSAP2007-01-18d06236e962d9…
2024-10-29 15:01 UTC2024-10A077861-003CARBOPLATIN450MG/45ML (10MG/ML)INJECTABLE / INTRAVENOUSAP2007-01-18d06236e962d9…
2024-10-29 15:01 UTC2024-10A077861-004CARBOPLATIN600MG/60ML (10MG/ML)INJECTABLE / INTRAVENOUSAP2007-01-18d06236e962d9…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 164 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
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…
2024-10-29 15:01 UTC2024-10A077861-001AP1d06236e962d9…
2024-10-29 15:01 UTC2024-10A077861-002AP1d06236e962d9…
2024-10-29 15:01 UTC2024-10A077861-003AP1d06236e962d9…
2024-10-29 15:01 UTC2024-10A077861-004AP1d06236e962d9…

Additional Listing Data#

Finished product
Yes
Brand name base
CARBOPLATIN
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CARBOPLATIN450 mg/45mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
BG3F62OND5Internal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
4c89cedc-e48b-445c-ad05-54dbe60e4fb0Available on FDA.report

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleStatus
69339-366-45693390366451 VIAL, MULTI-DOSE in 1 CARTON (69339-366-45) / 45 mL in 1 VIAL, MULTI-DOSE2026-07-020Current