FDA.reportPublic FDA data

NDC 49396-0512 - Instanyl

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
49396-0512
Package NDCs from labels
49396-0512-1
Manufacturer
Renaissance Lakewood LLC
Effective date
2024-11-27
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Fentanyl Nasal Spray - Renaissance Lakewood LLCRenaissance Lakewood LLC2024-11-27HUMAN PRESCRIPTION DRUG LABEL

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49396-0512INSTANYL (FENTANYL NASAL SPRAY) SPRAY [RENAISSANCE LAKEWOOD LLC]4Unmatched20241129_92c19d5a-0fe2-777d-e053-2995a90a4f3f.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 11 of 11 · 210 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
FREDS SALINE TWIN PACK LAXATIVESODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM AND SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORMFRED'S7d15057f-eb3b-477f-ab14-68c3c38ea9102018-12-26WarningsExact identifier
unii: GR686LBA74
unii: 3980JIH2SW
Dynamic Eyewash with EyecupWATERDynamic Safety International7d3af0f4-0e1f-9ea5-e053-2991aa0af7a22018-12-17WarningsExact identifier
unii: 059QF0KO0R
Bio Rock WaterROCK WATERBioActive Nutritional, Inc.178bd16d-0d4f-49d8-866b-8ab3a3c6889d2018-07-30WarningsExact identifier
unii: 059QF0KO0R
Marcs Twin PackSODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM AND SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORMMarc Glassman Inc.66348ee5-803a-4b78-94dd-55bc9d3543c32018-07-10WarningsExact identifier
unii: GR686LBA74
unii: 3980JIH2SW
Sterile WaterWATERBaxter Healthcare Corporationef3e79c5-3f58-4b36-a296-64b7d9a651c12017-10-17Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
QUALITY CHOICE SINGLE SALINE LAXATIVESODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM AND SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORMAlcyon Health, LLC.eb499c7f-9c7b-4097-83a3-82aabffd6beb2017-07-12WarningsExact identifier
unii: GR686LBA74
unii: 3980JIH2SW
Pro-Enema Single Saline LaxativeSODIUM PHOSPHATE, DIBASIC AND SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORMPropharma Medical Suppliese53c5eda-21da-4aed-a592-315100167cc22017-06-08WarningsExact identifier
unii: GR686LBA74
unii: 3980JIH2SW
Saline Laxative Cherry LaxativeSODIUM PHOSPHATE, DIBASIC AND SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORMDolgencorp Inc.ca3c00d9-4301-4de8-94f5-34f1bcc761ab2017-04-13WarningsExact identifier
unii: GR686LBA74
unii: 3980JIH2SW
Eye WashWATERCVS Pharmacy049cee29-7ec2-4d5b-8308-f522acde43a72017-03-29WarningsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERBaxter Healthcare Company210dc9ab-d6ca-4552-ac19-1be17792d2902016-05-31Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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