Home NDC 16729-295 Carboplatin
Product NDC 16729-295
11-digit product format 167290295
Labeler code 16729
Product ID 16729-295_35cf6068-f31a-211b-e063-6294a90a6b53
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Carboplatin
Dosage form INJECTION
Route INTRAVENOUS
Labeler Accord Healthcare, Inc.
Application ANDA206775
Marketing category ANDA
Marketing start 2017-09-19
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 42 .
Orange Book products# Current product rows page 1 of 1 · 5 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A206775-001 CARBOPLATIN CARBOPLATIN 50MG/5ML (10MG/ML) INJECTABLE / INTRAVENOUS AP 2017-02-09 A206775-002 CARBOPLATIN CARBOPLATIN 150MG/15ML (10MG/ML) INJECTABLE / INTRAVENOUS AP 2017-02-09 A206775-003 CARBOPLATIN CARBOPLATIN 450MG/45ML (10MG/ML) INJECTABLE / INTRAVENOUS AP 2017-02-09 A206775-004 CARBOPLATIN CARBOPLATIN 600MG/60ML (10MG/ML) INJECTABLE / INTRAVENOUS AP 2017-02-09 A206775-005 CARBOPLATIN CARBOPLATIN 1GM/100ML (10MG/ML) INJECTABLE / INTRAVENOUS RS 2020-04-06
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 6 · 206 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 A206775-001 CARBOPLATIN 50MG/5ML (10MG/ML) INJECTABLE / INTRAVENOUS AP 2017-02-09 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A206775-002 CARBOPLATIN 150MG/15ML (10MG/ML) INJECTABLE / INTRAVENOUS AP 2017-02-09 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A206775-003 CARBOPLATIN 450MG/45ML (10MG/ML) INJECTABLE / INTRAVENOUS AP 2017-02-09 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A206775-004 CARBOPLATIN 600MG/60ML (10MG/ML) INJECTABLE / INTRAVENOUS AP 2017-02-09 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A206775-005 CARBOPLATIN 1GM/100ML (10MG/ML) INJECTABLE / INTRAVENOUS RS 2020-04-06 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A206775-001 CARBOPLATIN 50MG/5ML (10MG/ML) INJECTABLE / INTRAVENOUS AP 2017-02-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A206775-002 CARBOPLATIN 150MG/15ML (10MG/ML) INJECTABLE / INTRAVENOUS AP 2017-02-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A206775-003 CARBOPLATIN 450MG/45ML (10MG/ML) INJECTABLE / INTRAVENOUS AP 2017-02-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A206775-004 CARBOPLATIN 600MG/60ML (10MG/ML) INJECTABLE / INTRAVENOUS AP 2017-02-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A206775-005 CARBOPLATIN 1GM/100ML (10MG/ML) INJECTABLE / INTRAVENOUS RS 2020-04-06 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A206775-001 CARBOPLATIN 50MG/5ML (10MG/ML) INJECTABLE / INTRAVENOUS AP 2017-02-09 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A206775-002 CARBOPLATIN 150MG/15ML (10MG/ML) INJECTABLE / INTRAVENOUS AP 2017-02-09 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A206775-003 CARBOPLATIN 450MG/45ML (10MG/ML) INJECTABLE / INTRAVENOUS AP 2017-02-09 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A206775-004 CARBOPLATIN 600MG/60ML (10MG/ML) INJECTABLE / INTRAVENOUS AP 2017-02-09 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A206775-005 CARBOPLATIN 1GM/100ML (10MG/ML) INJECTABLE / INTRAVENOUS RS 2020-04-06 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A206775-001 CARBOPLATIN 50MG/5ML (10MG/ML) INJECTABLE / INTRAVENOUS AP 2017-02-09 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A206775-002 CARBOPLATIN 150MG/15ML (10MG/ML) INJECTABLE / INTRAVENOUS AP 2017-02-09 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A206775-003 CARBOPLATIN 450MG/45ML (10MG/ML) INJECTABLE / INTRAVENOUS AP 2017-02-09 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A206775-004 CARBOPLATIN 600MG/60ML (10MG/ML) INJECTABLE / INTRAVENOUS AP 2017-02-09 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A206775-005 CARBOPLATIN 1GM/100ML (10MG/ML) INJECTABLE / INTRAVENOUS RS 2020-04-06 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A206775-001 CARBOPLATIN 50MG/5ML (10MG/ML) INJECTABLE / INTRAVENOUS AP 2017-02-09 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A206775-002 CARBOPLATIN 150MG/15ML (10MG/ML) INJECTABLE / INTRAVENOUS AP 2017-02-09 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A206775-003 CARBOPLATIN 450MG/45ML (10MG/ML) INJECTABLE / INTRAVENOUS AP 2017-02-09 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A206775-004 CARBOPLATIN 600MG/60ML (10MG/ML) INJECTABLE / INTRAVENOUS AP 2017-02-09 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A206775-005 CARBOPLATIN 1GM/100ML (10MG/ML) INJECTABLE / INTRAVENOUS RS 2020-04-06 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A206775-001 CARBOPLATIN 50MG/5ML (10MG/ML) INJECTABLE / INTRAVENOUS AP 2017-02-09 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A206775-002 CARBOPLATIN 150MG/15ML (10MG/ML) INJECTABLE / INTRAVENOUS AP 2017-02-09 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A206775-003 CARBOPLATIN 450MG/45ML (10MG/ML) INJECTABLE / INTRAVENOUS AP 2017-02-09 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A206775-004 CARBOPLATIN 600MG/60ML (10MG/ML) INJECTABLE / INTRAVENOUS AP 2017-02-09 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A206775-005 CARBOPLATIN 1GM/100ML (10MG/ML) INJECTABLE / INTRAVENOUS RS 2020-04-06 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A206775-001 CARBOPLATIN 50MG/5ML (10MG/ML) INJECTABLE / INTRAVENOUS AP 2017-02-09 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A206775-002 CARBOPLATIN 150MG/15ML (10MG/ML) INJECTABLE / INTRAVENOUS AP 2017-02-09 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A206775-003 CARBOPLATIN 450MG/45ML (10MG/ML) INJECTABLE / INTRAVENOUS AP 2017-02-09 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A206775-004 CARBOPLATIN 600MG/60ML (10MG/ML) INJECTABLE / INTRAVENOUS AP 2017-02-09 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A206775-005 CARBOPLATIN 1GM/100ML (10MG/ML) INJECTABLE / INTRAVENOUS RS 2020-04-06 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A206775-001 CARBOPLATIN 50MG/5ML (10MG/ML) INJECTABLE / INTRAVENOUS AP 2017-02-09 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A206775-002 CARBOPLATIN 150MG/15ML (10MG/ML) INJECTABLE / INTRAVENOUS AP 2017-02-09 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A206775-003 CARBOPLATIN 450MG/45ML (10MG/ML) INJECTABLE / INTRAVENOUS AP 2017-02-09 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A206775-004 CARBOPLATIN 600MG/60ML (10MG/ML) INJECTABLE / INTRAVENOUS AP 2017-02-09 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A206775-005 CARBOPLATIN 1GM/100ML (10MG/ML) INJECTABLE / INTRAVENOUS RS 2020-04-06 2680178bc6a6…
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 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# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 16729-295 CARBOPLATIN INJECTION [ACCORD HEALTHCARE, INC.] 8 Current NDC, Legacy NDC, 10 package rows 20250524_48aa7ef3-9f44-2a08-e054-00144ff88e88.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 · 1 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 16729-295-12 16729029512 1 VIAL, MULTI-DOSE in 1 CARTON (16729-295-12) / 60 mL in 1 VIAL, MULTI-DOSE 2017-10-03 0000-00-00 No No Current 16729-295-31 16729029531 1 VIAL, MULTI-DOSE in 1 CARTON (16729-295-31) / 5 mL in 1 VIAL, MULTI-DOSE 2017-09-19 0000-00-00 No No Current 16729-295-33 16729029533 1 VIAL, MULTI-DOSE in 1 CARTON (16729-295-33) / 15 mL in 1 VIAL, MULTI-DOSE 2017-09-19 0000-00-00 No No Current 16729-295-34 16729029534 1 VIAL, MULTI-DOSE in 1 CARTON (16729-295-34) / 45 mL in 1 VIAL, MULTI-DOSE 2017-09-19 0000-00-00 No No Current 16729-295-38 16729029538 1 in 1 CARTON Historical