Home NDC 54288-164 CARBOPLATIN
Product NDC 54288-164
11-digit product format 542880164
Labeler code 54288
Product ID 54288-164_c0a7463c-d90f-4060-a54e-6a4888e8af0e
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Carboplatin
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler BPI Labs LLC
Application ANDA207324
Marketing category ANDA
Marketing start 2023-07-31
Substance CARBOPLATIN
Active strength 10 mg/mL
Pharmacologic classes Platinum-based Drug [EPC], Platinum-containing Compounds [EXT]
NDC exclude flag No
Listing certified through 2026-12-31
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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A207324-001 CARBOPLATIN CARBOPLATIN 50MG/5ML (10MG/ML) INJECTABLE / INTRAVENOUS AP 2017-02-15 A207324-002 CARBOPLATIN CARBOPLATIN 150MG/15ML (10MG/ML) INJECTABLE / INTRAVENOUS AP 2017-02-15 A207324-003 CARBOPLATIN CARBOPLATIN 450MG/45ML (10MG/ML) INJECTABLE / INTRAVENOUS AP 2017-02-15 A207324-004 CARBOPLATIN CARBOPLATIN 600MG/60ML (10MG/ML) INJECTABLE / INTRAVENOUS AP 2017-02-15
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 4 matching rows.
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 A207324-001 CARBOPLATIN 50MG/5ML (10MG/ML) INJECTABLE / INTRAVENOUS AP 2017-02-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A207324-002 CARBOPLATIN 150MG/15ML (10MG/ML) INJECTABLE / INTRAVENOUS AP 2017-02-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A207324-003 CARBOPLATIN 450MG/45ML (10MG/ML) INJECTABLE / INTRAVENOUS AP 2017-02-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A207324-004 CARBOPLATIN 600MG/60ML (10MG/ML) INJECTABLE / INTRAVENOUS AP 2017-02-15 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A207324-001 CARBOPLATIN 50MG/5ML (10MG/ML) INJECTABLE / INTRAVENOUS AP 2017-02-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A207324-002 CARBOPLATIN 150MG/15ML (10MG/ML) INJECTABLE / INTRAVENOUS AP 2017-02-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A207324-003 CARBOPLATIN 450MG/45ML (10MG/ML) INJECTABLE / INTRAVENOUS AP 2017-02-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A207324-004 CARBOPLATIN 600MG/60ML (10MG/ML) INJECTABLE / INTRAVENOUS AP 2017-02-15 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A207324-001 CARBOPLATIN 50MG/5ML (10MG/ML) INJECTABLE / INTRAVENOUS AP 2017-02-15 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A207324-002 CARBOPLATIN 150MG/15ML (10MG/ML) INJECTABLE / INTRAVENOUS AP 2017-02-15 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A207324-003 CARBOPLATIN 450MG/45ML (10MG/ML) INJECTABLE / INTRAVENOUS AP 2017-02-15 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A207324-004 CARBOPLATIN 600MG/60ML (10MG/ML) INJECTABLE / INTRAVENOUS AP 2017-02-15 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A207324-001 CARBOPLATIN 50MG/5ML (10MG/ML) INJECTABLE / INTRAVENOUS AP 2017-02-15 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A207324-002 CARBOPLATIN 150MG/15ML (10MG/ML) INJECTABLE / INTRAVENOUS AP 2017-02-15 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A207324-003 CARBOPLATIN 450MG/45ML (10MG/ML) INJECTABLE / INTRAVENOUS AP 2017-02-15 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A207324-004 CARBOPLATIN 600MG/60ML (10MG/ML) INJECTABLE / INTRAVENOUS AP 2017-02-15 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A207324-001 CARBOPLATIN 50MG/5ML (10MG/ML) INJECTABLE / INTRAVENOUS AP 2017-02-15 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A207324-002 CARBOPLATIN 150MG/15ML (10MG/ML) INJECTABLE / INTRAVENOUS AP 2017-02-15 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A207324-003 CARBOPLATIN 450MG/45ML (10MG/ML) INJECTABLE / INTRAVENOUS AP 2017-02-15 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A207324-004 CARBOPLATIN 600MG/60ML (10MG/ML) INJECTABLE / INTRAVENOUS AP 2017-02-15 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A207324-001 CARBOPLATIN 50MG/5ML (10MG/ML) INJECTABLE / INTRAVENOUS AP 2017-02-15 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A207324-002 CARBOPLATIN 150MG/15ML (10MG/ML) INJECTABLE / INTRAVENOUS AP 2017-02-15 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A207324-003 CARBOPLATIN 450MG/45ML (10MG/ML) INJECTABLE / INTRAVENOUS AP 2017-02-15 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A207324-004 CARBOPLATIN 600MG/60ML (10MG/ML) INJECTABLE / INTRAVENOUS AP 2017-02-15 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A207324-001 CARBOPLATIN 50MG/5ML (10MG/ML) INJECTABLE / INTRAVENOUS AP 2017-02-15 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A207324-002 CARBOPLATIN 150MG/15ML (10MG/ML) INJECTABLE / INTRAVENOUS AP 2017-02-15 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A207324-003 CARBOPLATIN 450MG/45ML (10MG/ML) INJECTABLE / INTRAVENOUS AP 2017-02-15 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A207324-004 CARBOPLATIN 600MG/60ML (10MG/ML) INJECTABLE / INTRAVENOUS AP 2017-02-15 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A207324-001 CARBOPLATIN 50MG/5ML (10MG/ML) INJECTABLE / INTRAVENOUS AP 2017-02-15 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A207324-002 CARBOPLATIN 150MG/15ML (10MG/ML) INJECTABLE / INTRAVENOUS AP 2017-02-15 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A207324-003 CARBOPLATIN 450MG/45ML (10MG/ML) INJECTABLE / INTRAVENOUS AP 2017-02-15 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A207324-004 CARBOPLATIN 600MG/60ML (10MG/ML) INJECTABLE / INTRAVENOUS AP 2017-02-15 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A207324-001 CARBOPLATIN 50MG/5ML (10MG/ML) INJECTABLE / INTRAVENOUS AP 2017-02-15 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A207324-002 CARBOPLATIN 150MG/15ML (10MG/ML) INJECTABLE / INTRAVENOUS AP 2017-02-15 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A207324-003 CARBOPLATIN 450MG/45ML (10MG/ML) INJECTABLE / INTRAVENOUS AP 2017-02-15 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A207324-004 CARBOPLATIN 600MG/60ML (10MG/ML) INJECTABLE / INTRAVENOUS AP 2017-02-15 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A207324-001 CARBOPLATIN 50MG/5ML (10MG/ML) INJECTABLE / INTRAVENOUS AP 2017-02-15 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A207324-002 CARBOPLATIN 150MG/15ML (10MG/ML) INJECTABLE / INTRAVENOUS AP 2017-02-15 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A207324-003 CARBOPLATIN 450MG/45ML (10MG/ML) INJECTABLE / INTRAVENOUS AP 2017-02-15 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A207324-004 CARBOPLATIN 600MG/60ML (10MG/ML) INJECTABLE / INTRAVENOUS AP 2017-02-15 d06236e962d9…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 5 · 164 observed states.
Additional Listing Data#
Finished product Yes
Brand name base CARBOPLATIN
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CARBOPLATIN 10 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination BG3F62OND5 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 597195 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 54288-164-01 CARBOPLATIN 1 in 1 CARTON INJECTION, SOLUTION 1 5 54288-164-01 CARBOPLATIN 5 mL in 1 VIAL, MULTI-DOSE INJECTION, SOLUTION 5 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 54288-164 CARBOPLATIN INJECTION, SOLUTION [BPI LABS LLC] 4 Current NDC, 2 package rows 20250213_5484d2f0-0cc2-4bba-8f26-c7f6539a9606.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 · 2 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 54288-164-01 54288016401 1 VIAL, MULTI-DOSE in 1 CARTON (54288-164-01) / 5 mL in 1 VIAL, MULTI-DOSE 2023-07-31 No No Current