Home NDC 16729-288 Cisplatin
Product NDC 16729-288
11-digit product format 167290288
Labeler code 16729
Product ID 16729-288_2860827e-1817-2b85-e063-6394a90a127e
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Cisplatin
Dosage form INJECTION
Route INTRAVENOUS
Labeler Accord Healthcare Inc.
Application ANDA206774
Marketing category ANDA
Marketing start 2016-12-13
Substance CISPLATIN
Active strength 1 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 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A206774-001 CISPLATIN CISPLATIN 1MG/ML INJECTABLE / INJECTION AP 2015-08-18
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A206774-001 AP
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 2 · 41 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 A206774-001 CISPLATIN 1MG/ML INJECTABLE / INJECTION AP 2015-08-18 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A206774-001 CISPLATIN 1MG/ML INJECTABLE / INJECTION AP 2015-08-18 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A206774-001 CISPLATIN 1MG/ML INJECTABLE / INJECTION AP 2015-08-18 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A206774-001 CISPLATIN 1MG/ML INJECTABLE / INJECTION AP 2015-08-18 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A206774-001 CISPLATIN 1MG/ML INJECTABLE / INJECTION AP 2015-08-18 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A206774-001 CISPLATIN 1MG/ML INJECTABLE / INJECTION AP 2015-08-18 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A206774-001 CISPLATIN 1MG/ML INJECTABLE / INJECTION AP 2015-08-18 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A206774-001 CISPLATIN 1MG/ML INJECTABLE / INJECTION AP 2015-08-18 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A206774-001 CISPLATIN 1MG/ML INJECTABLE / INJECTION AP 2015-08-18 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A206774-001 CISPLATIN 1MG/ML INJECTABLE / INJECTION AP 2015-08-18 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A206774-001 CISPLATIN 1MG/ML INJECTABLE / INJECTION AP 2015-08-18 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A206774-001 CISPLATIN 1MG/ML INJECTABLE / INJECTION AP 2015-08-18 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A206774-001 CISPLATIN 1MG/ML INJECTABLE / INJECTION AP 2015-08-18 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A206774-001 CISPLATIN 1MG/ML INJECTABLE / INJECTION AP 2015-08-18 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A206774-001 CISPLATIN 1MG/ML INJECTABLE / INJECTION AP 2015-08-18 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A206774-001 CISPLATIN 1MG/ML INJECTABLE / INJECTION AP 2015-08-18 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A206774-001 CISPLATIN 1MG/ML INJECTABLE / INJECTION AP 2015-08-18 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A206774-001 CISPLATIN 1MG/ML INJECTABLE / INJECTION AP 2015-08-18 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A206774-001 CISPLATIN 1MG/ML INJECTABLE / INJECTION AP 2015-08-18 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A206774-001 CISPLATIN 1MG/ML INJECTABLE / INJECTION AP 2015-08-18 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A206774-001 CISPLATIN 1MG/ML INJECTABLE / INJECTION AP 2015-08-18 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A206774-001 CISPLATIN 1MG/ML INJECTABLE / INJECTION AP 2015-08-18 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A206774-001 CISPLATIN 1MG/ML INJECTABLE / INJECTION AP 2015-08-18 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A206774-001 CISPLATIN 1MG/ML INJECTABLE / INJECTION AP 2015-08-18 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A206774-001 CISPLATIN 1MG/ML INJECTABLE / INJECTION AP 2015-08-18 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A206774-001 CISPLATIN 1MG/ML INJECTABLE / INJECTION AP 2015-08-18 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A206774-001 CISPLATIN 1MG/ML INJECTABLE / INJECTION AP 2015-08-18 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A206774-001 CISPLATIN 1MG/ML INJECTABLE / INJECTION AP 2015-08-18 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A206774-001 CISPLATIN 1MG/ML INJECTABLE / INJECTION AP 2015-08-18 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A206774-001 CISPLATIN 1MG/ML INJECTABLE / INJECTION AP 2015-08-18 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A206774-001 CISPLATIN 1MG/ML INJECTABLE / INJECTION AP 2015-08-18 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A206774-001 CISPLATIN 1MG/ML INJECTABLE / INJECTION AP 2015-08-18 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A206774-001 CISPLATIN 1MG/ML INJECTABLE / INJECTION AP 2015-08-18 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A206774-001 CISPLATIN 1MG/ML INJECTABLE / INJECTION AP 2015-08-18 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A206774-001 CISPLATIN 1MG/ML INJECTABLE / INJECTION AP 2015-08-18 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A206774-001 CISPLATIN 1MG/ML INJECTABLE / INJECTION AP 2015-08-18 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A206774-001 CISPLATIN 1MG/ML INJECTABLE / INJECTION AP 2015-08-18 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A206774-001 CISPLATIN 1MG/ML INJECTABLE / INJECTION AP 2015-08-18 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A206774-001 CISPLATIN 1MG/ML INJECTABLE / INJECTION AP 2015-08-18 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A206774-001 CISPLATIN 1MG/ML INJECTABLE / INJECTION AP 2015-08-18 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Cisplatin
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CISPLATIN 1 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination Q20Q21Q62J Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 309311 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 16729-288-11 Cisplatin 50 mL in 1 VIAL INJECTION 50 6 16729-288-38 Cisplatin 100 mL in 1 VIAL INJECTION 100 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 16729-288 CISPLATIN INJECTION [ACCORD HEALTHCARE INC.] 6 Current NDC, Legacy NDC, 2 package rows 20241206_b2b029f5-0d7e-4e7f-accc-b722aec34c68.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 Units Marketing start Marketing end Sample Exclude flag Status 16729-288-11 16729028811 50 mL in 1 VIAL (16729-288-11) 50 ml 2016-12-13 0000-00-00 No No Current 16729-288-38 16729028838 100 mL in 1 VIAL (16729-288-38) 100 ml 2016-12-13 0000-00-00 No No Current