Home NDC 68001-283 Cisplatin
Product NDC 68001-283
11-digit product format 680010283
Labeler code 68001
Product ID 68001-283_11314cd7-5167-4699-e063-6394a90a93b8
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Cisplatin
Dosage form INJECTION
Route INTRAVENOUS
Labeler BluePoint Laboratories
Application ANDA206774
Marketing category ANDA
Marketing start 2016-08-02
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 42 .
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 · 42 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 A206774-001 CISPLATIN 1MG/ML INJECTABLE / INJECTION AP 2015-08-18 caaa826d4ba7…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…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 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 68001-283-24 Cisplatin 50 mL in 1 VIAL INJECTION 50 4 68001-283-27 Cisplatin 1 in 1 CARTON INJECTION 1 4 68001-283-32 Cisplatin 1 in 1 CARTON INJECTION 1 4 68001-283-33 Cisplatin 100 mL in 1 VIAL INJECTION 100 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68001-283 CISPLATIN INJECTION [BLUEPOINT LABORATORIES] 4 Current NDC, Legacy NDC, 4 package rows 20240213_a60c5173-6bc0-4c9d-9674-b3f4d68f79ba.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 68001-283-24 68001028324 50 mL in 1 VIAL 50 ml Historical 68001-283-27 68001028327 1 VIAL in 1 CARTON (68001-283-27) / 50 mL in 1 VIAL (68001-283-24) 1 vial 2016-08-02 0000-00-00 No No Current 68001-283-32 68001028332 1 VIAL in 1 CARTON (68001-283-32) / 100 mL in 1 VIAL (68001-283-33) 1 vial 2016-08-02 0000-00-00 No No Current 68001-283-33 68001028333 100 mL in 1 VIAL 100 ml Historical