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 25 of 26 · 506 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
IntralipidI. V. FAT EMULSIONBaxter Healthcare Corporationdd269651-30e8-43f0-880f-484346eaafeb2022-07-21Boxed warning, Adverse reactionsExact identifier
unii: 241ATL177A
GlycerinumGLYCERINUMHahnemann Laboratories, INC.e34f8796-85b5-2946-e053-2995a90a251e2022-07-08Exact identifier
unii: PDC6A3C0OX
REFRESH Optive Mega-3CARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN AND POLYSORBATE 80Allergan, Inc.c5f2b3f2-2071-45bd-a010-67f848bc02332022-06-30WarningsExact identifier
unii: PDC6A3C0OX
Sterile WaterWATERFresenius Kabi USA, LLCf42ac50f-0ec5-4713-a4c8-99d972d90bed2022-06-22Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERFresenius Kabi USA, LLCe71c6c83-d518-496c-b2ab-efd5987e47832022-06-09Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Miracle FootCream LavenderUREA, GLYCERIN, ALOE, DISODIUM EDTAAloe Vera Korea Co.,Ltd.db520c80-2a2a-5eb1-e053-2995a90a5bb42022-03-28WarningsExact identifier
unii: 7FLD91C86K
unii: PDC6A3C0OX
Miracle FootCream LemonUREA, GLYCERIN, ALOE, DISODIUM EDTAAloe Vera Korea Co.,Ltd.db525c63-29fd-2033-e053-2995a90a56b92022-03-28WarningsExact identifier
unii: 7FLD91C86K
unii: PDC6A3C0OX
Sterile WaterWATERAmerican Regent, Inc.78b35864-4bbc-4759-a5c1-7e4f25e229322022-01-31Boxed warningExact identifier
unii: 059QF0KO0R
Sterile Diluent for TreprostinilWATERDr.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
TOTAL ANDRO BALCHOLESTERINUM, DAMIANA, DNA, HYPOTHALAMUS, LECITHIN, PHOSPHORICUM AC, SABALWhite Manufacturing Inc. DBA Micro-Weste0716657-b579-4183-baf6-8d554f9bf1bb2021-01-21WarningsExact identifier
unii: 1Z74184RGV
TOTAL TRI-ESTROADRENALINUM, CIMICIFUGA, IGNATIA, LECITHIN, NICOTINAMIDUM, OOPHORINUM, SEPIA.White Manufacturing Inc. DBA Micro-Westd3a5e7b6-a4d2-406e-b837-600a886b0ff42021-01-21WarningsExact identifier
unii: 1Z74184RGV
Sterile WaterWATERAsclemed USA, Inc.45c38269-883c-4198-a9d5-03810a4420ec2021-01-14Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Bach Original Flower RemediesWATERNelson Bach USA Limited09c76050-42c5-4403-865c-a1f6f668d9c02020-06-15WarningsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERBaxter Healthcare Company8bcf5572-49e1-4302-9522-56f57904cb4a2019-12-29Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
IntralipidI.V. FAT EMULSIONBaxter Healthcare Corporationcbd3396e-6b85-41bf-82d2-940beba866862019-01-09Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 241ATL177A
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

Reported adverse events (FAERS/openFDA)#

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