NDC 67184-0502-01 - Oxaliplatin

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC: 67184-0502
Requested NDC: 67184-0502-01
Package NDCs from labels: 67184-0502-1, 67184-0502-01
Manufacturer: Qilu Pharmaceutical Co., Ltd. | Qilu Pharmaceutical Co., (Hainan) Ltd. | Qilu Pharmaceutical (Hainan) Co., Ltd.
Effective date: 2021-10-18
Current FDA listing: Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
Label	Manufacturer	Effective date	Type
Oxaliplatin	Qilu Pharmaceutical Co., Ltd. \| Qilu Pharmaceutical Co., (Hainan) Ltd. \| Qilu Pharmaceutical (Hainan) Co., Ltd.	2021-10-18	HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
67184-0502-1	Oxaliplatin	20 mL in 1 VIAL, SINGLE-DOSE	INJECTION, POWDER, LYOPHILIZED,	20		3
67184-0502-1	Oxaliplatin	1 in 1 CARTON	INJECTION, POWDER, LYOPHILIZED,	1		3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
67184-0502	OXALIPLATIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [QILU PHARMACEUTICAL CO., LTD.]	3	Current NDC, Legacy NDC, 2 package rows	20211020_e9e47f3c-9acc-44f5-b0bd-d26fe9d35d64.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 2 of 2 · 24 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Oxaliplatin	OXALIPLATIN	Baxter Healthcare Corporation	21a2bb1d-d91d-4f99-97dd-cc67fe99a090	2023-07-20	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: 04ZR38536J
Oxaliplatin	OXALIPLATIN	Sandoz Inc	ab162009-6f84-4d56-ab56-5e84409ec814	2023-07-11	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: 04ZR38536J
Oxaliplatin	OXALIPLATIN	Qilu Pharmaceutical Co., Ltd.	e9e47f3c-9acc-44f5-b0bd-d26fe9d35d64	2021-10-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application number: ANDA204616 ndc (package): 67184-0501-1 ndc (package): 67184-0502-1 ndc (product): 67184-0501 ndc (product): 67184-0502 ndc11 (package): 67184050201 rxcui: 1736784 rxcui: 1736786 spl id: f9f54aa0-22e3-4958-b368-d89d716ac2fa spl set id: e9e47f3c-9acc-44f5-b0bd-d26fe9d35d64 unii: 04ZR38536J
Oxaliplatin	OXALIPLATIN	Gland Pharma Limited	d6178bc6-9dae-413f-8f47-de75d576c5b8	2017-05-26	Boxed warning, Warnings, Adverse reactions	Exact identifier rxcui: 1736784 rxcui: 1736786 unii: 04ZR38536J

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.