FDA.reportPublic FDA data

NDC 16714-528-01 - propofol

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
16714-528
Requested NDC
16714-528-01
Package NDCs from labels
16714-528-01, 16714-528-10, 16714-528-20
Manufacturer
NorthStar Rx LLC
Effective date
2026-09-22
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
propofol - NorthStar Rx LLCNorthStar Rx LLC2026-09-22HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
16714-528-01propofol20 mL in 1 VIALINJECTION, EMULSION205
16714-528-10propofol10 in 1 CARTONINJECTION, EMULSION105
16714-528-20propofol20 in 1 CARTONINJECTION, EMULSION205

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16714-528PROPOFOL INJECTION, EMULSION [NORTHSTAR RX LLC]4Current NDC, Legacy NDC, 3 package rows20241207_5ec25932-6c21-4cd5-8f60-80761f2e20a6.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16714-528-01ML - Milliliter16714-528042e6926-96c7-4cdf-82e9-4779a5ac774612022-09-12
16714-528-10ML - Milliliter16714-528867e43f4-0b22-4c73-8510-e1ca3dbedc9e12022-09-12
16714-528-20ML - Milliliter16714-528ed6e5f06-ee76-4e79-b035-6a40f325807c12022-09-12

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 26 of 26 · 506 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Homeoplex DGLYCERINUM, PHYTOLACCA DECANDRA, TARAXACUM OFFICINALE, ARSENICUM ALBUM, NITRICUM ACIDUM, NUX VOMICA, PETROLEUM, PHOSPHORICUM ACIDUM, PHOSPHORUS, ACETYLSALICYLICUM ACIDUM, GLONOINUM, INSULINUM (SUIS), LITHIUM CARBONICUM, THYROIDINUM (SUIS), SALICYLICUM ACIDUM, ADRENOCORTICOTROPHIN, CORTISONE ACETICUM, EUGENOL, STEARYL ALCOHOL, XYLITOL, FOLLICULINUM, BENZOICUM ACIDUM, CHLORINUM, POTASSIUM SORBATE, SORBITOL, RESORCINUM, BENZYL ALCOHOL, LACTICUM ACIDUM, ISOPROPYL PALMITATE, BORICUM ACIDUM, ACETICUM ACIDUM,Supplement Clinic, LLC.cd6b48ab-3566-484d-8deb-15ef6f8e7e8f2017-11-01WarningsExact identifier
unii: PDC6A3C0OX
Sterile WaterWATERBaxter Healthcare Corporationef3e79c5-3f58-4b36-a296-64b7d9a651c12017-10-17Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Cardio TonicKALI MURIATICUM, KALI PHOSPHORICUM, PLANTAGO MAJOR, CACTUS GRANDIFLORUS, DIGITALIS PURPUREA, HEART (BOVINE), L-CARNITINE, L-VALINE, THYROIDINUM (SUIS), ABROTANUM (ARTEMISIA ABROTANUM), IODIUM, LECITHIN, SPIGELIA ANTHELMIABioActive Nutritional, Inc.2c252ba6-f147-4c22-b432-cd603a9623ac2017-08-14WarningsExact identifier
unii: 1Z74184RGV
FIND BICHON CLEANSING MASKGLYCERINPioom Cosmetic Co.,ltd50b7db48-7b55-6df4-e054-00144ff88e882017-05-30WarningsExact identifier
unii: PDC6A3C0OX
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.