Home NDC 68083-162 CISPLATIN
Product NDC 68083-162
11-digit product format 680830162
Labeler code 68083
Product ID 68083-162_89007399-3c34-40d2-8068-a0b8e09cbef8
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Cisplatin
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler Gland Pharma Limited
Application ANDA207323
Marketing category ANDA
Marketing start 2017-04-03
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 A207323-001 CISPLATIN CISPLATIN 1MG/ML INJECTABLE / INJECTION AP 2017-03-17
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A207323-001 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 A207323-001 CISPLATIN 1MG/ML INJECTABLE / INJECTION AP 2017-03-17 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A207323-001 CISPLATIN 1MG/ML INJECTABLE / INJECTION AP 2017-03-17 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A207323-001 CISPLATIN 1MG/ML INJECTABLE / INJECTION AP 2017-03-17 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A207323-001 CISPLATIN 1MG/ML INJECTABLE / INJECTION AP 2017-03-17 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A207323-001 CISPLATIN 1MG/ML INJECTABLE / INJECTION AP 2017-03-17 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A207323-001 CISPLATIN 1MG/ML INJECTABLE / INJECTION AP 2017-03-17 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A207323-001 CISPLATIN 1MG/ML INJECTABLE / INJECTION AP 2017-03-17 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A207323-001 CISPLATIN 1MG/ML INJECTABLE / INJECTION AP 2017-03-17 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A207323-001 CISPLATIN 1MG/ML INJECTABLE / INJECTION AP 2017-03-17 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A207323-001 CISPLATIN 1MG/ML INJECTABLE / INJECTION AP 2017-03-17 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A207323-001 CISPLATIN 1MG/ML INJECTABLE / INJECTION AP 2017-03-17 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A207323-001 CISPLATIN 1MG/ML INJECTABLE / INJECTION AP 2017-03-17 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A207323-001 CISPLATIN 1MG/ML INJECTABLE / INJECTION AP 2017-03-17 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A207323-001 CISPLATIN 1MG/ML INJECTABLE / INJECTION AP 2017-03-17 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A207323-001 CISPLATIN 1MG/ML INJECTABLE / INJECTION AP 2017-03-17 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A207323-001 CISPLATIN 1MG/ML INJECTABLE / INJECTION AP 2017-03-17 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A207323-001 CISPLATIN 1MG/ML INJECTABLE / INJECTION AP 2017-03-17 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A207323-001 CISPLATIN 1MG/ML INJECTABLE / INJECTION AP 2017-03-17 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A207323-001 CISPLATIN 1MG/ML INJECTABLE / INJECTION AP 2017-03-17 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A207323-001 CISPLATIN 1MG/ML INJECTABLE / INJECTION AP 2017-03-17 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A207323-001 CISPLATIN 1MG/ML INJECTABLE / INJECTION AP 2017-03-17 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A207323-001 CISPLATIN 1MG/ML INJECTABLE / INJECTION AP 2017-03-17 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A207323-001 CISPLATIN 1MG/ML INJECTABLE / INJECTION AP 2017-03-17 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A207323-001 CISPLATIN 1MG/ML INJECTABLE / INJECTION AP 2017-03-17 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A207323-001 CISPLATIN 1MG/ML INJECTABLE / INJECTION AP 2017-03-17 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A207323-001 CISPLATIN 1MG/ML INJECTABLE / INJECTION AP 2017-03-17 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A207323-001 CISPLATIN 1MG/ML INJECTABLE / INJECTION AP 2017-03-17 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A207323-001 CISPLATIN 1MG/ML INJECTABLE / INJECTION AP 2017-03-17 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A207323-001 CISPLATIN 1MG/ML INJECTABLE / INJECTION AP 2017-03-17 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A207323-001 CISPLATIN 1MG/ML INJECTABLE / INJECTION AP 2017-03-17 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A207323-001 CISPLATIN 1MG/ML INJECTABLE / INJECTION AP 2017-03-17 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A207323-001 CISPLATIN 1MG/ML INJECTABLE / INJECTION AP 2017-03-17 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A207323-001 CISPLATIN 1MG/ML INJECTABLE / INJECTION AP 2017-03-17 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A207323-001 CISPLATIN 1MG/ML INJECTABLE / INJECTION AP 2017-03-17 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A207323-001 CISPLATIN 1MG/ML INJECTABLE / INJECTION AP 2017-03-17 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A207323-001 CISPLATIN 1MG/ML INJECTABLE / INJECTION AP 2017-03-17 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A207323-001 CISPLATIN 1MG/ML INJECTABLE / INJECTION AP 2017-03-17 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A207323-001 CISPLATIN 1MG/ML INJECTABLE / INJECTION AP 2017-03-17 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A207323-001 CISPLATIN 1MG/ML INJECTABLE / INJECTION AP 2017-03-17 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A207323-001 CISPLATIN 1MG/ML INJECTABLE / INJECTION AP 2017-03-17 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 68083-162-01 CISPLATIN 50 mL in 1 VIAL INJECTION, SOLUTION 50 6 68083-162-01 CISPLATIN 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 68083-162 CISPLATIN INJECTION, SOLUTION [GLAND PHARMA LIMITED] 6 Current NDC, Legacy NDC, 2 package rows 20231018_a32820f7-9ff6-4c13-a96a-4483a943fe82.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 · 4 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join CISPLATIN CISPLATIN FOSUN PHARMA USA INC 0219eae9-82b4-b779-e063-6394a90a311e 2024-05-16 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 207323 application number: ANDA207323 Cisplatin CISPLATIN Sagent Pharmaceuticals 00396546-6a80-4b9f-a5f8-c22c1d1bb173 2024-01-20 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 207323 application number: ANDA207323 CISPLATIN CISPLATIN BluePoint Laboratories 0372598e-4837-43c6-b56f-63527ac94559 2023-12-18 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 207323 application number: ANDA207323 CISPLATIN CISPLATIN Gland Pharma Limited a32820f7-9ff6-4c13-a96a-4483a943fe82 2023-09-26 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 207323 application number: ANDA207323 ndc (product): 68083-162
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 68083-162-01 68083016201 1 VIAL in 1 CARTON (68083-162-01) / 50 mL in 1 VIAL 1 vial 2017-04-03 0000-00-00 No No Current