Home NDC 0703-5747 Cisplatin
Product NDC 0703-5747
11-digit product format 007035747
Labeler code 0703
Product ID 0703-5747_adf5773e-9095-4cb4-a90f-72cbf82f4493
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Cisplatin
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler Teva Parenteral Medicines, Inc.
Application ANDA074656
Marketing category ANDA
Marketing start 2000-06-01
Substance CISPLATIN
Active strength 50 mg/50mL
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 A074656-001 CISPLATIN CISPLATIN 1MG/ML INJECTABLE / INJECTION AP 2000-05-16
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A074656-001 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 A074656-001 CISPLATIN 1MG/ML INJECTABLE / INJECTION AP 2000-05-16 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A074656-001 CISPLATIN 1MG/ML INJECTABLE / INJECTION AP 2000-05-16 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A074656-001 CISPLATIN 1MG/ML INJECTABLE / INJECTION AP 2000-05-16 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A074656-001 CISPLATIN 1MG/ML INJECTABLE / INJECTION AP 2000-05-16 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A074656-001 CISPLATIN 1MG/ML INJECTABLE / INJECTION AP 2000-05-16 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A074656-001 CISPLATIN 1MG/ML INJECTABLE / INJECTION AP 2000-05-16 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A074656-001 CISPLATIN 1MG/ML INJECTABLE / INJECTION AP 2000-05-16 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A074656-001 CISPLATIN 1MG/ML INJECTABLE / INJECTION AP 2000-05-16 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A074656-001 CISPLATIN 1MG/ML INJECTABLE / INJECTION AP 2000-05-16 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A074656-001 CISPLATIN 1MG/ML INJECTABLE / INJECTION AP 2000-05-16 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A074656-001 CISPLATIN 1MG/ML INJECTABLE / INJECTION AP 2000-05-16 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A074656-001 CISPLATIN 1MG/ML INJECTABLE / INJECTION AP 2000-05-16 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A074656-001 CISPLATIN 1MG/ML INJECTABLE / INJECTION AP 2000-05-16 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A074656-001 CISPLATIN 1MG/ML INJECTABLE / INJECTION AP 2000-05-16 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A074656-001 CISPLATIN 1MG/ML INJECTABLE / INJECTION AP 2000-05-16 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A074656-001 CISPLATIN 1MG/ML INJECTABLE / INJECTION AP 2000-05-16 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A074656-001 CISPLATIN 1MG/ML INJECTABLE / INJECTION AP 2000-05-16 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A074656-001 CISPLATIN 1MG/ML INJECTABLE / INJECTION AP 2000-05-16 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A074656-001 CISPLATIN 1MG/ML INJECTABLE / INJECTION AP 2000-05-16 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A074656-001 CISPLATIN 1MG/ML INJECTABLE / INJECTION AP 2000-05-16 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A074656-001 CISPLATIN 1MG/ML INJECTABLE / INJECTION AP 2000-05-16 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A074656-001 CISPLATIN 1MG/ML INJECTABLE / INJECTION AP 2000-05-16 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A074656-001 CISPLATIN 1MG/ML INJECTABLE / INJECTION AP 2000-05-16 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A074656-001 CISPLATIN 1MG/ML INJECTABLE / INJECTION AP 2000-05-16 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A074656-001 CISPLATIN 1MG/ML INJECTABLE / INJECTION AP 2000-05-16 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A074656-001 CISPLATIN 1MG/ML INJECTABLE / INJECTION AP 2000-05-16 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A074656-001 CISPLATIN 1MG/ML INJECTABLE / INJECTION AP 2000-05-16 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A074656-001 CISPLATIN 1MG/ML INJECTABLE / INJECTION AP 2000-05-16 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A074656-001 CISPLATIN 1MG/ML INJECTABLE / INJECTION AP 2000-05-16 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A074656-001 CISPLATIN 1MG/ML INJECTABLE / INJECTION AP 2000-05-16 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A074656-001 CISPLATIN 1MG/ML INJECTABLE / INJECTION AP 2000-05-16 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A074656-001 CISPLATIN 1MG/ML INJECTABLE / INJECTION AP 2000-05-16 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A074656-001 CISPLATIN 1MG/ML INJECTABLE / INJECTION AP 2000-05-16 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A074656-001 CISPLATIN 1MG/ML INJECTABLE / INJECTION AP 2000-05-16 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A074656-001 CISPLATIN 1MG/ML INJECTABLE / INJECTION AP 2000-05-16 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A074656-001 CISPLATIN 1MG/ML INJECTABLE / INJECTION AP 2000-05-16 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A074656-001 CISPLATIN 1MG/ML INJECTABLE / INJECTION AP 2000-05-16 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A074656-001 CISPLATIN 1MG/ML INJECTABLE / INJECTION AP 2000-05-16 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A074656-001 CISPLATIN 1MG/ML INJECTABLE / INJECTION AP 2000-05-16 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A074656-001 CISPLATIN 1MG/ML INJECTABLE / INJECTION AP 2000-05-16 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 50 mg/50mL
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 0703-5747-11 Cisplatin 1 in 1 CARTON INJECTION, SOLUTION 1 12 0703-5747-11 Cisplatin 50 mL in 1 VIAL, MULTI-DOSE INJECTION, SOLUTION 50 12
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded CISPLATIN ACTIVE INGREDIENT Q20Q21Q62J CISPLATIN INJECTION, SOLUTION [TEVA PARENTERAL MEDICINES, INC.] 7 CISPLATIN ACTIVE MOIETY Q20Q21Q62J CISPLATIN INJECTION, SOLUTION [TEVA PARENTERAL MEDICINES, INC.] 7 HYDROCHLORIC ACID INACTIVE INGREDIENT QTT17582CB CISPLATIN INJECTION, SOLUTION [TEVA PARENTERAL MEDICINES, INC.] 7 SODIUM CHLORIDE INACTIVE INGREDIENT 451W47IQ8X CISPLATIN INJECTION, SOLUTION [TEVA PARENTERAL MEDICINES, INC.] 7 SODIUM HYDROXIDE INACTIVE INGREDIENT 55X04QC32I CISPLATIN INJECTION, SOLUTION [TEVA PARENTERAL MEDICINES, INC.] 7 WATER INACTIVE INGREDIENT 059QF0KO0R CISPLATIN INJECTION, SOLUTION [TEVA PARENTERAL MEDICINES, INC.] 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0703-5747 CISPLATIN INJECTION, SOLUTION [TEVA PARENTERAL MEDICINES, INC.] 12 Current NDC, Legacy NDC, 2 package rows 20221001_a440f077-46f6-4688-a209-65bce38d1c92.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 Marketing start Marketing end Sample Exclude flag Status 0703-5747-11 00703574711 1 VIAL, MULTI-DOSE in 1 CARTON (0703-5747-11) / 50 mL in 1 VIAL, MULTI-DOSE 2000-06-01 0000-00-00 No No Current