NDC 68083-261 - Melphalan hydrochloride

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: 68083-261
Package NDCs from labels: 68083-261-01
Manufacturer: Gland Pharma Limited
Effective date: 2019-06-07
Current FDA listing: Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
Label	Manufacturer	Effective date	Type
Melphalan hydrochloride - Gland Pharma Limited	Gland Pharma Limited	2019-06-07	Human Prescription Drug Label

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68083-261	MELPHALAN HYDROCHLORIDE KIT [GLAND PHARMA LIMITED]	5	Unmatched	20190610_ea7fbf4e-4980-4bb4-bac9-99eb6f633ba0.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 156 of 157 · 3,137 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Sterile Water	WATER	Fresenius Kabi USA, LLC	e71c6c83-d518-496c-b2ab-efd5987e4783	2022-06-09	Warnings, Adverse reactions	Exact identifier unii: 059QF0KO0R
Addiclenz	BETA VULGARIS, BOLDO, CHELIDONIUM MAJUS, PETROSELINUM SATIVUM, TARAXACUM OFFICINALE, ARSENICUM ALBUM, BISPHENOL A, COBALTUM METALLICUM, CUPRUM METALLICUM, GLYPHOSATE, IODIUM, LYCOPODIUM CLAVATUM, PHOSPHORICUM ACIDUM, SELENIUM METALLICUM, ZINCUM METALLICUM, ASPARTAME, BENZALKONIUM CHLORIDE, FORMALINUM, METHYLENE CHLORIDE, METHYL PARABEN, PROPYL PARABEN, SODIUM BENZOATE, SODIUM CITRATE, TITANIUM DIOXIDE, ZINCUM OXYDATUM	Deseret Biologicals, Inc.	e39235ea-2a2f-44a7-92d6-fb1d428ebabd	2022-05-12	Warnings	Exact identifier unii: 1Q73Q2JULR
ACD-A	ANTICOAGULANT CITRATE DEXTROSE SOLUTION FORMULA A	Fenwal, Inc.	22805f0d-ba58-41ea-b245-19980abcda22	2022-02-11		Exact identifier unii: 1Q73Q2JULR
Sterile Water	WATER	American Regent, Inc.	78b35864-4bbc-4759-a5c1-7e4f25e22932	2022-01-31	Boxed warning	Exact identifier unii: 059QF0KO0R
Sterile Diluent for Treprostinil	WATER	Dr.Reddy's Laboratories Inc.,	33050ee2-519b-1f0b-d4df-9e14dd329c57	2021-12-23	Warnings, Adverse reactions	Exact identifier unii: 059QF0KO0R
Sterile Water	STERILE WATER	B. Braun Medical Inc.	d99f9133-e4d0-4dee-b611-dbc3f918b547	2021-08-09	Warnings, Adverse reactions	Exact identifier unii: 059QF0KO0R
Sterile Water	WATER	B. Braun Medical Inc.	8924e52e-8622-4ed6-a061-1908183e0a18	2021-08-06	Warnings, Adverse reactions	Exact identifier unii: 059QF0KO0R
Eyewash	EYEWASH	Global Equipment Company	c4f78121-4668-2e0c-e053-2995a90ab6c6	2021-06-17	Warnings	Exact identifier unii: 059QF0KO0R
Melphalan hydrochloride	MELPHALAN HYDROCHLORIDE	Meitheal Pharmaceuticals Inc.	d99b3865-e0f0-482a-9ec6-da642e5104ea	2021-06-07	Boxed warning, Warnings, Adverse reactions	Exact identifier rxcui: 311487
Sterile Water	WATER	Asclemed USA, Inc.	45c38269-883c-4198-a9d5-03810a4420ec	2021-01-14	Warnings, Adverse reactions	Exact identifier unii: 059QF0KO0R
Hand Sanitizer	HAND SANITIZER	LS Promotions Inc.	a187d9fc-e5ce-2b48-e053-2995a90a0c0e	2020-12-09	Warnings	Exact identifier unii: 3K9958V90M
Hand Sanitizer Lemon 2oz	ALCOHOL	Ningbo Rejoice International	b0a4159a-cb07-4ce6-e053-2995a90a76e7	2020-10-02	Warnings	Exact identifier unii: 3K9958V90M
Melphalan Hydrochloride	MELPHALAN HYDROCHLORIDE	Mylan Institutional LLC	a8bf1877-fd06-4ef6-b82d-fe0ff1956bde	2020-09-16	Boxed warning, Warnings, Adverse reactions	Exact identifier rxcui: 311487
Bach Original Flower Remedies	WATER	Nelson Bach USA Limited	09c76050-42c5-4403-865c-a1f6f668d9c0	2020-06-15	Warnings	Exact identifier unii: 059QF0KO0R
Sanix Alcohol Hand Rub	ALCOHOL	Topiderm, Inc	a4fbb714-4f20-400a-ab98-f1c8807ce6fc	2020-03-24	Warnings	Exact identifier unii: 3K9958V90M
Sterile Water	WATER	Baxter Healthcare Company	8bcf5572-49e1-4302-9522-56f57904cb4a	2019-12-29	Warnings, Adverse reactions	Exact identifier unii: 059QF0KO0R
Melphalan hydrochloride	MELPHALAN HYDROCHLORIDE	Fosun Pharma USA Inc	54712714-744d-4deb-83b2-694da49a9272	2019-07-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application number: ANDA209826 rxcui: 311487
Melphalan hydrochloride	MELPHALAN HYDROCHLORIDE	Gland Pharma Limited	ea7fbf4e-4980-4bb4-bac9-99eb6f633ba0	2019-06-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application number: ANDA209826 ndc (package): 68083-260-01 ndc (package): 68083-261-01 ndc (package): 68083-259-01 ndc (product): 68083-259 rxcui: 311487 spl id: c1a5c2ee-7acc-44f6-8e95-534a2d88e223 spl set id: ea7fbf4e-4980-4bb4-bac9-99eb6f633ba0
Dynamic Eyewash with Eyecup	WATER	Dynamic Safety International	7d3af0f4-0e1f-9ea5-e053-2991aa0af7a2	2018-12-17	Warnings	Exact identifier unii: 059QF0KO0R
Foaming Mousse Anti-Bacterial Hand Sanitizer Pink Grapefruit Scented	ALCOHOL	Ganzhou Olivee Cosmetic Co., Ltd.	461859ad-7833-47ae-90da-1dea5f26cc4b	2018-12-01	Warnings	Exact identifier unii: 3K9958V90M

Reported adverse events (FAERS/openFDA)#

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