Home NDC 82511-003 CARBOPLATIN
Product NDC 82511-003
11-digit product format 825110003
Labeler code 82511
Product ID 82511-003_2b3f8994-659d-b905-e063-6394a90a3aec
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name CARBOPLATIN
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler Teyro Labs Private Limited
Application ANDA077861
Marketing category ANDA
Marketing start 2007-01-18
Substance CARBOPLATIN
Active strength 50 mg/5mL
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 42 .
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 A077861-001 CARBOPLATIN CARBOPLATIN 50MG/5ML (10MG/ML) INJECTABLE / INTRAVENOUS AP 2007-01-18 A077861-002 CARBOPLATIN CARBOPLATIN 150MG/15ML (10MG/ML) INJECTABLE / INTRAVENOUS AP 2007-01-18 A077861-003 CARBOPLATIN CARBOPLATIN 450MG/45ML (10MG/ML) INJECTABLE / INTRAVENOUS AP 2007-01-18 A077861-004 CARBOPLATIN CARBOPLATIN 600MG/60ML (10MG/ML) INJECTABLE / INTRAVENOUS AP 2007-01-18
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 · 168 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 2026-08-18 06:07:40 2026-07 A077861-001 CARBOPLATIN 50MG/5ML (10MG/ML) INJECTABLE / INTRAVENOUS AP 2007-01-18 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A077861-002 CARBOPLATIN 150MG/15ML (10MG/ML) INJECTABLE / INTRAVENOUS AP 2007-01-18 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A077861-003 CARBOPLATIN 450MG/45ML (10MG/ML) INJECTABLE / INTRAVENOUS AP 2007-01-18 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A077861-004 CARBOPLATIN 600MG/60ML (10MG/ML) INJECTABLE / INTRAVENOUS AP 2007-01-18 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A077861-001 CARBOPLATIN 50MG/5ML (10MG/ML) INJECTABLE / INTRAVENOUS AP 2007-01-18 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A077861-002 CARBOPLATIN 150MG/15ML (10MG/ML) INJECTABLE / INTRAVENOUS AP 2007-01-18 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A077861-003 CARBOPLATIN 450MG/45ML (10MG/ML) INJECTABLE / INTRAVENOUS AP 2007-01-18 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A077861-004 CARBOPLATIN 600MG/60ML (10MG/ML) INJECTABLE / INTRAVENOUS AP 2007-01-18 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077861-001 CARBOPLATIN 50MG/5ML (10MG/ML) INJECTABLE / INTRAVENOUS AP 2007-01-18 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077861-002 CARBOPLATIN 150MG/15ML (10MG/ML) INJECTABLE / INTRAVENOUS AP 2007-01-18 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077861-003 CARBOPLATIN 450MG/45ML (10MG/ML) INJECTABLE / INTRAVENOUS AP 2007-01-18 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077861-004 CARBOPLATIN 600MG/60ML (10MG/ML) INJECTABLE / INTRAVENOUS AP 2007-01-18 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A077861-001 CARBOPLATIN 50MG/5ML (10MG/ML) INJECTABLE / INTRAVENOUS AP 2007-01-18 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A077861-002 CARBOPLATIN 150MG/15ML (10MG/ML) INJECTABLE / INTRAVENOUS AP 2007-01-18 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A077861-003 CARBOPLATIN 450MG/45ML (10MG/ML) INJECTABLE / INTRAVENOUS AP 2007-01-18 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A077861-004 CARBOPLATIN 600MG/60ML (10MG/ML) INJECTABLE / INTRAVENOUS AP 2007-01-18 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077861-001 CARBOPLATIN 50MG/5ML (10MG/ML) INJECTABLE / INTRAVENOUS AP 2007-01-18 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077861-002 CARBOPLATIN 150MG/15ML (10MG/ML) INJECTABLE / INTRAVENOUS AP 2007-01-18 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077861-003 CARBOPLATIN 450MG/45ML (10MG/ML) INJECTABLE / INTRAVENOUS AP 2007-01-18 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077861-004 CARBOPLATIN 600MG/60ML (10MG/ML) INJECTABLE / INTRAVENOUS AP 2007-01-18 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077861-001 CARBOPLATIN 50MG/5ML (10MG/ML) INJECTABLE / INTRAVENOUS AP 2007-01-18 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077861-002 CARBOPLATIN 150MG/15ML (10MG/ML) INJECTABLE / INTRAVENOUS AP 2007-01-18 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077861-003 CARBOPLATIN 450MG/45ML (10MG/ML) INJECTABLE / INTRAVENOUS AP 2007-01-18 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077861-004 CARBOPLATIN 600MG/60ML (10MG/ML) INJECTABLE / INTRAVENOUS AP 2007-01-18 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077861-001 CARBOPLATIN 50MG/5ML (10MG/ML) INJECTABLE / INTRAVENOUS AP 2007-01-18 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077861-002 CARBOPLATIN 150MG/15ML (10MG/ML) INJECTABLE / INTRAVENOUS AP 2007-01-18 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077861-003 CARBOPLATIN 450MG/45ML (10MG/ML) INJECTABLE / INTRAVENOUS AP 2007-01-18 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077861-004 CARBOPLATIN 600MG/60ML (10MG/ML) INJECTABLE / INTRAVENOUS AP 2007-01-18 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077861-001 CARBOPLATIN 50MG/5ML (10MG/ML) INJECTABLE / INTRAVENOUS AP 2007-01-18 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077861-002 CARBOPLATIN 150MG/15ML (10MG/ML) INJECTABLE / INTRAVENOUS AP 2007-01-18 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077861-003 CARBOPLATIN 450MG/45ML (10MG/ML) INJECTABLE / INTRAVENOUS AP 2007-01-18 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077861-004 CARBOPLATIN 600MG/60ML (10MG/ML) INJECTABLE / INTRAVENOUS AP 2007-01-18 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077861-001 CARBOPLATIN 50MG/5ML (10MG/ML) INJECTABLE / INTRAVENOUS AP 2007-01-18 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077861-002 CARBOPLATIN 150MG/15ML (10MG/ML) INJECTABLE / INTRAVENOUS AP 2007-01-18 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077861-003 CARBOPLATIN 450MG/45ML (10MG/ML) INJECTABLE / INTRAVENOUS AP 2007-01-18 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077861-004 CARBOPLATIN 600MG/60ML (10MG/ML) INJECTABLE / INTRAVENOUS AP 2007-01-18 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077861-001 CARBOPLATIN 50MG/5ML (10MG/ML) INJECTABLE / INTRAVENOUS AP 2007-01-18 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077861-002 CARBOPLATIN 150MG/15ML (10MG/ML) INJECTABLE / INTRAVENOUS AP 2007-01-18 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077861-003 CARBOPLATIN 450MG/45ML (10MG/ML) INJECTABLE / INTRAVENOUS AP 2007-01-18 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077861-004 CARBOPLATIN 600MG/60ML (10MG/ML) INJECTABLE / INTRAVENOUS AP 2007-01-18 d8e5a09893c0…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 5 · 168 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 50 mg/5mL
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 82511-003-05 CARBOPLATIN 5 mL in 1 VIAL, MULTI-DOSE INJECTION, SOLUTION 5 6 82511-003-05 CARBOPLATIN 1 in 1 CARTON INJECTION, SOLUTION 1 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 82511-003 CARBOPLATIN INJECTION, SOLUTION [TEYRO LABS PRIVATE LIMITED] 6 Current NDC, 2 package rows 20250110_f64a0cbe-7fe3-407e-8933-21c30e1a1ebc.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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 82511-003-05 82511000305 1 VIAL, MULTI-DOSE in 1 CARTON (82511-003-05) / 5 mL in 1 VIAL, MULTI-DOSE 2007-01-18 No No Current