Home NDC 60505-6279 CISplatin
Product NDC 60505-6279
11-digit product format 605056279
Labeler code 60505
Product ID 60505-6279_0e147fbc-5660-4d80-b834-f069e8487f59
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name CISplatin
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler Apotex Corp.
Application ANDA218868
Marketing category ANDA
Marketing start 2024-09-13
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 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 A218868-001 CISPLATIN CISPLATIN 1MG/ML INJECTABLE / INJECTION AP 2024-05-10
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A218868-001 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.
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 A218868-001 CISPLATIN 1MG/ML INJECTABLE / INJECTION AP 2024-05-10 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A218868-001 CISPLATIN 1MG/ML INJECTABLE / INJECTION AP 2024-05-10 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A218868-001 CISPLATIN 1MG/ML INJECTABLE / INJECTION AP 2024-05-10 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A218868-001 CISPLATIN 1MG/ML INJECTABLE / INJECTION AP 2024-05-10 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A218868-001 CISPLATIN 1MG/ML INJECTABLE / INJECTION AP 2024-05-10 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A218868-001 CISPLATIN 1MG/ML INJECTABLE / INJECTION AP 2024-05-10 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A218868-001 CISPLATIN 1MG/ML INJECTABLE / INJECTION AP 2024-05-10 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A218868-001 CISPLATIN 1MG/ML INJECTABLE / INJECTION AP 2024-05-10 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A218868-001 CISPLATIN 1MG/ML INJECTABLE / INJECTION AP 2024-05-10 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A218868-001 CISPLATIN 1MG/ML INJECTABLE / INJECTION AP 2024-05-10 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A218868-001 CISPLATIN 1MG/ML INJECTABLE / INJECTION AP 2024-05-10 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A218868-001 CISPLATIN 1MG/ML INJECTABLE / INJECTION AP 2024-05-10 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A218868-001 CISPLATIN 1MG/ML INJECTABLE / INJECTION AP 2024-05-10 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A218868-001 CISPLATIN 1MG/ML INJECTABLE / INJECTION AP 2024-05-10 1e350fbaab3a…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A218868-001 CISPLATIN 1MG/ML INJECTABLE / INJECTION AP 2024-05-10 a50c72e98297…
Observed Orange Book normalized TE history# 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 60505-6279-0 CISplatin 1 in 1 CARTON INJECTION, SOLUTION 1 5 60505-6279-0 CISplatin 50 mL in 1 VIAL, MULTI-DOSE INJECTION, SOLUTION 50 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 60505-6279 CISPLATIN INJECTION, SOLUTION [APOTEX CORP.] 5 Current NDC, 2 package rows 20240920_8d170f6f-37d7-41ce-aae2-33307a6ef3ae.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 Sample Exclude flag Status 60505-6279-0 60505627900 1 VIAL, MULTI-DOSE in 1 CARTON (60505-6279-0) / 50 mL in 1 VIAL, MULTI-DOSE 2024-09-13 No No Current