FDA.reportPublic FDA data

NDC 68083-261-01 - 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
Requested NDC
68083-261-01
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
LabelManufacturerEffective dateType
Melphalan hydrochloride - Gland Pharma LimitedGland Pharma Limited2019-06-07Human Prescription Drug Label

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68083-261MELPHALAN HYDROCHLORIDE KIT [GLAND PHARMA LIMITED]5Unmatched20190610_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 155 of 156 · 3,113 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TreprostinilTREPROSTINILDr.Reddy's Laboratories Inc.,33050ee2-519b-1f0b-d4df-9e14dd329c572021-12-23Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Sterile WaterSTERILE WATERB. Braun Medical Inc.d99f9133-e4d0-4dee-b611-dbc3f918b5472021-08-09Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERB. Braun Medical Inc.8924e52e-8622-4ed6-a061-1908183e0a182021-08-06Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
EyewashEYEWASHGlobal Equipment Companyc4f78121-4668-2e0c-e053-2995a90ab6c62021-06-17WarningsExact identifier
unii: 059QF0KO0R
Melphalan hydrochlorideMELPHALAN HYDROCHLORIDEMeitheal Pharmaceuticals Inc.d99b3865-e0f0-482a-9ec6-da642e5104ea2021-06-07Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 311487
Sterile WaterWATERAsclemed USA, Inc.45c38269-883c-4198-a9d5-03810a4420ec2021-01-14Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Hand SanitizerHAND SANITIZERLS Promotions Inc.a187d9fc-e5ce-2b48-e053-2995a90a0c0e2020-12-09WarningsExact identifier
unii: 3K9958V90M
Hand Sanitizer Lemon 2ozALCOHOLNingbo Rejoice Internationalb0a4159a-cb07-4ce6-e053-2995a90a76e72020-10-02WarningsExact identifier
unii: 3K9958V90M
Melphalan HydrochlorideMELPHALAN HYDROCHLORIDEMylan Institutional LLCa8bf1877-fd06-4ef6-b82d-fe0ff1956bde2020-09-16Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 311487
Bach Original Flower RemediesWATERNelson Bach USA Limited09c76050-42c5-4403-865c-a1f6f668d9c02020-06-15WarningsExact identifier
unii: 059QF0KO0R
Sanix Alcohol Hand RubALCOHOLTopiderm, Inca4fbb714-4f20-400a-ab98-f1c8807ce6fc2020-03-24WarningsExact identifier
unii: 3K9958V90M
Sterile WaterWATERBaxter Healthcare Company8bcf5572-49e1-4302-9522-56f57904cb4a2019-12-29Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Melphalan hydrochlorideMELPHALAN HYDROCHLORIDEFosun Pharma USA Inc54712714-744d-4deb-83b2-694da49a92722019-07-28Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA209826
rxcui: 311487
Melphalan hydrochlorideMELPHALAN HYDROCHLORIDEGland Pharma Limitedea7fbf4e-4980-4bb4-bac9-99eb6f633ba02019-06-07Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA209826
ndc (package): 68083-260-01
ndc (package): 68083-261-01
ndc (package): 68083-259-01
ndc (product): 68083-259
ndc11 (package): 68083026101
rxcui: 311487
spl id: c1a5c2ee-7acc-44f6-8e95-534a2d88e223
spl set id: ea7fbf4e-4980-4bb4-bac9-99eb6f633ba0
Dynamic Eyewash with EyecupWATERDynamic Safety International7d3af0f4-0e1f-9ea5-e053-2991aa0af7a22018-12-17WarningsExact identifier
unii: 059QF0KO0R
Foaming Mousse Anti-Bacterial Hand Sanitizer Pink Grapefruit ScentedALCOHOLGanzhou Olivee Cosmetic Co., Ltd.461859ad-7833-47ae-90da-1dea5f26cc4b2018-12-01WarningsExact identifier
unii: 3K9958V90M
Foaming Mousse Anti-Bacterial Hand Sanitizer Pineapple ScentedALCOHOLGanzhou Olivee Cosmetic Co., Ltd.f8139155-865c-40e5-a5c5-58a629361a0b2018-11-28WarningsExact identifier
unii: 3K9958V90M
Foaming Mousse Anti-Bacterial Hand Sanitizer Cherry ScentedALCOHOLGanzhou Olivee Cosmetic Co., Ltd.35bd0f8f-1602-4713-b20f-8dc38e2761c22018-11-28WarningsExact identifier
unii: 3K9958V90M
Afassco Hand SanitizerALCOHOLJIANGMEN SHUIZIRUN SANITARY ARTICLES CO., LTD.efbcbfe1-27c6-45c9-b51e-926e298ee7532018-10-18WarningsExact identifier
unii: 3K9958V90M
Bio Rock WaterROCK WATERBioActive Nutritional, Inc.178bd16d-0d4f-49d8-866b-8ab3a3c6889d2018-07-30WarningsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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