Home NDC 63323-103 Cisplatin
Product NDC 63323-103
11-digit product format 633230103
Labeler code 63323
Product ID 63323-103_24604fc6-875c-4f70-973a-9cca93f9a7a7
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name CISPLATIN
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler Fresenius Kabi USA, LLC
Application ANDA074735
Marketing category ANDA
Marketing start 2000-09-05
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 A074735-001 CISPLATIN CISPLATIN 1MG/ML INJECTABLE / INJECTION AP RS 1999-07-16
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A074735-001 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 A074735-001 CISPLATIN 1MG/ML INJECTABLE / INJECTION AP RS 1999-07-16 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A074735-001 CISPLATIN 1MG/ML INJECTABLE / INJECTION AP RS 1999-07-16 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A074735-001 CISPLATIN 1MG/ML INJECTABLE / INJECTION AP RS 1999-07-16 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A074735-001 CISPLATIN 1MG/ML INJECTABLE / INJECTION AP RS 1999-07-16 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A074735-001 CISPLATIN 1MG/ML INJECTABLE / INJECTION AP RS 1999-07-16 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A074735-001 CISPLATIN 1MG/ML INJECTABLE / INJECTION AP RS 1999-07-16 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A074735-001 CISPLATIN 1MG/ML INJECTABLE / INJECTION AP RS 1999-07-16 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A074735-001 CISPLATIN 1MG/ML INJECTABLE / INJECTION AP RS 1999-07-16 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A074735-001 CISPLATIN 1MG/ML INJECTABLE / INJECTION AP RS 1999-07-16 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A074735-001 CISPLATIN 1MG/ML INJECTABLE / INJECTION AP RS 1999-07-16 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A074735-001 CISPLATIN 1MG/ML INJECTABLE / INJECTION AP RS 1999-07-16 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A074735-001 CISPLATIN 1MG/ML INJECTABLE / INJECTION AP RS 1999-07-16 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A074735-001 CISPLATIN 1MG/ML INJECTABLE / INJECTION AP RS 1999-07-16 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A074735-001 CISPLATIN 1MG/ML INJECTABLE / INJECTION AP RS 1999-07-16 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A074735-001 CISPLATIN 1MG/ML INJECTABLE / INJECTION AP RS 1999-07-16 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A074735-001 CISPLATIN 1MG/ML INJECTABLE / INJECTION AP RS 1999-07-16 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A074735-001 CISPLATIN 1MG/ML INJECTABLE / INJECTION AP RS 1999-07-16 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A074735-001 CISPLATIN 1MG/ML INJECTABLE / INJECTION AP RS 1999-07-16 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A074735-001 CISPLATIN 1MG/ML INJECTABLE / INJECTION AP RS 1999-07-16 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A074735-001 CISPLATIN 1MG/ML INJECTABLE / INJECTION AP RS 1999-07-16 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A074735-001 CISPLATIN 1MG/ML INJECTABLE / INJECTION AP RS 1999-07-16 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A074735-001 CISPLATIN 1MG/ML INJECTABLE / INJECTION AP RS 1999-07-16 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A074735-001 CISPLATIN 1MG/ML INJECTABLE / INJECTION AP RS 1999-07-16 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A074735-001 CISPLATIN 1MG/ML INJECTABLE / INJECTION AP RS 1999-07-16 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A074735-001 CISPLATIN 1MG/ML INJECTABLE / INJECTION AP RS 1999-07-16 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A074735-001 CISPLATIN 1MG/ML INJECTABLE / INJECTION AP RS 1999-07-16 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A074735-001 CISPLATIN 1MG/ML INJECTABLE / INJECTION AP RS 1999-07-16 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A074735-001 CISPLATIN 1MG/ML INJECTABLE / INJECTION AP RS 1999-07-16 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A074735-001 CISPLATIN 1MG/ML INJECTABLE / INJECTION AP RS 1999-07-16 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A074735-001 CISPLATIN 1MG/ML INJECTABLE / INJECTION AP RS 1999-07-16 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A074735-001 CISPLATIN 1MG/ML INJECTABLE / INJECTION AP RS 1999-07-16 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A074735-001 CISPLATIN 1MG/ML INJECTABLE / INJECTION AP RS 1999-07-16 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A074735-001 CISPLATIN 1MG/ML INJECTABLE / INJECTION AP RS 1999-07-16 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A074735-001 CISPLATIN 1MG/ML INJECTABLE / INJECTION AP RS 1999-07-16 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A074735-001 CISPLATIN 1MG/ML INJECTABLE / INJECTION AP RS 1999-07-16 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A074735-001 CISPLATIN 1MG/ML INJECTABLE / INJECTION AP RS 1999-07-16 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A074735-001 CISPLATIN 1MG/ML INJECTABLE / INJECTION AP RS 1999-07-16 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A074735-001 CISPLATIN 1MG/ML INJECTABLE / INJECTION AP RS 1999-07-16 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A074735-001 CISPLATIN 1MG/ML INJECTABLE / INJECTION AP RS 1999-07-16 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A074735-001 CISPLATIN 1MG/ML INJECTABLE / INJECTION AP RS 1999-07-16 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 63323-103-51 Cisplatin 50 mL in 1 VIAL INJECTION, SOLUTION 50 7 63323-103-51 Cisplatin 1 in 1 CARTON INJECTION, SOLUTION 1 7 63323-103-64 Cisplatin 200 mL in 1 VIAL INJECTION, SOLUTION 200 7 63323-103-64 Cisplatin 1 in 1 CARTON INJECTION, SOLUTION 1 7 63323-103-65 Cisplatin 1 in 1 CARTON INJECTION, SOLUTION 1 7 63323-103-65 Cisplatin 100 mL in 1 VIAL INJECTION, SOLUTION 100 7
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded CISPLATIN ACTIVE INGREDIENT Q20Q21Q62J CISPLATIN INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] 3 CISPLATIN ACTIVE MOIETY Q20Q21Q62J CISPLATIN INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] 3 HYDROCHLORIC ACID INACTIVE INGREDIENT QTT17582CB CISPLATIN INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] 3 SODIUM CHLORIDE INACTIVE INGREDIENT 451W47IQ8X CISPLATIN INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] 3 SODIUM HYDROXIDE INACTIVE INGREDIENT 55X04QC32I CISPLATIN INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63323-103 CISPLATIN (CISPLATIN) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] 7 Current NDC, Legacy NDC, 6 package rows 20241013_de6302d5-85f0-4116-a709-57826c2c84fe.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 Units Marketing start Marketing end Sample Exclude flag Status 63323-103-51 63323010351 1 VIAL in 1 CARTON (63323-103-51) / 50 mL in 1 VIAL 1 vial 2000-09-05 0000-00-00 No No Current 63323-103-64 63323010364 1 VIAL in 1 CARTON (63323-103-64) / 200 mL in 1 VIAL 1 vial 2000-09-05 0000-00-00 No No Current 63323-103-65 63323010365 1 VIAL in 1 CARTON (63323-103-65) / 100 mL in 1 VIAL 1 vial 2000-09-05 0000-00-00 No No Current