Home NDC 69448-005-12 PARAPLATIN
Product NDC 69448-005
Requested package NDC 69448-005-12
11-digit product format 694480005
Labeler code 69448
Product ID 69448-005_e69a06ea-e917-25ea-e053-2995a90a6f6f
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Carboplatin
Dosage form INJECTION
Route INTRAVENOUS
Labeler Accord BioPharma Inc.
Application ANDA206775
Marketing category ANDA
Marketing start 2020-02-12
Marketing end 0000-00-00
Substance CARBOPLATIN
Active strength 10 mg/mL
Pharmacologic classes Platinum-based Drug [EPC], Platinum-containing Compounds [EXT]
NDC exclude flag No
Listing certified through 2023-12-31
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…
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.
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 69448-005 PARAPLATIN (CARBOPLATIN) INJECTION [ACCORD BIOPHARMA INC.] 4 Legacy NDC 20220820_f88e0483-09be-4f60-be8f-964c02e3ece0.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.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Carboplatin CARBOPLATIN Accord Healthcare, Inc. 48aa7ef3-9f44-2a08-e054-00144ff88e88 2025-05-23 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 206775 application number: ANDA206775
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 69448-005-12 69448000512 1 VIAL, MULTI-DOSE in 1 CARTON (69448-005-12) > 60 mL in 1 VIAL, MULTI-DOSE 2020-02-12 2023-08-31 No No Current