FDA.reportPublic FDA data

NDC 43598-548-50 - Propofol Injectable Emulsion

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
43598-548
Requested NDC
43598-548-50
Package NDCs from labels
43598-548-50, 43598-548-21
Manufacturer
Dr. Reddy's Laboratories, Inc. | Corden Pharma SPA
Effective date
2022-09-30
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
propofol - Dr. Reddy's Laboratories, Inc. | Corden Pharma SPADr. Reddy's Laboratories, Inc. | Corden Pharma SPA2022-09-30HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43598-548-21Propofol Injectable Emulsion20 in 1 CARTONINJECTION, EMULSION205
43598-548-50Propofol Injectable Emulsion50 mL in 1 VIALINJECTION, EMULSION505

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43598-548PROPOFOL INJECTABLE EMULSION INJECTION, EMULSION [DR. REDDY'S LABORATORIES, INC.]5Current NDC, Legacy NDC, 2 package rows20230401_800646b8-83a8-01d9-3dc8-bb2ddcb8570c.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43598-548-21ML - Milliliter43598-54848d53e5f-ca01-4d83-b9ec-d9d002bda2e512019-02-13
43598-548-50ML - Milliliter43598-548a9035187-4f69-4a5d-95d2-42a4dac6bc2012019-02-13

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 19 of 20 · 382 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Refresh Digital PFCARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN AND POLYSORBATE 80Allergan, Inc.97e83e68-6374-4df4-93f6-d707fc32748d2022-11-28WarningsExact identifier
unii: PDC6A3C0OX
Refresh DigitalCARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN, POLYSORBATE 80Allergan, Inc.b2bd34d4-fab9-4f4b-9be2-5d30b55f5b812022-11-28WarningsExact identifier
unii: PDC6A3C0OX
PROPOFOLPROPOFOLHikma Pharmaceuticals USA Inc.fdb77e13-f5a7-4c4a-9f8e-338b702239c82022-11-18Warnings, Adverse reactionsExact identifier
rxcui: 1808224
rxcui: 1808217
rxcui: 1808222
unii: YI7VU623SF
Propofol Injectable EmulsionPROPOFOL INJECTABLE EMULSIONDr. Reddy's Laboratories, Inc.800646b8-83a8-01d9-3dc8-bb2ddcb8570c2022-09-30Warnings, Adverse reactionsExact identifier
application number: ANDA205067
ndc (package): 43598-265-25
ndc (package): 43598-265-58
ndc (package): 43598-549-52
ndc (package): 43598-549-10
ndc (package): 43598-548-21
ndc (package): 43598-548-50
ndc (package): 43598-265-20
ndc (product): 43598-549
ndc (product): 43598-548
ndc (product): 43598-265
ndc11 (package): 43598054850
rxcui: 1808224
rxcui: 1808217
rxcui: 1808222
spl id: b4a9147e-dfe3-229a-d8d7-6a84e6449f15
spl set id: 800646b8-83a8-01d9-3dc8-bb2ddcb8570c
unii: YI7VU623SF
REFRESH OPTIVECARBOXYMETHYLCELLULOSE SODIUM AND GLYCERINAllergan, Inc.7f8d88af-fd3b-4138-af61-f24c59ccebd72022-09-23WarningsExact identifier
unii: PDC6A3C0OX
REFRESH OPTIVE AdvancedCARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN, POLYSORBATE 80Allergan, Inc.ebd0839e-2e1d-4e0e-986c-19f1f5c763582022-09-15WarningsExact identifier
unii: PDC6A3C0OX
REFRESH OPTIVE AdvancedCARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN, AND POLYSORBATE 80Allergan, Inc.aaa943e4-7c38-4c5a-b7c0-5a656d8cafc02022-09-01WarningsExact identifier
unii: PDC6A3C0OX
IntralipidI.V. FAT EMULSIONBaxter Healthcare CORP069460a5-3e9a-428f-b2dc-3405690f4fd72022-07-25Boxed warning, Adverse reactionsExact identifier
unii: 241ATL177A
IntralipidI.V. FAT EMULSIONBaxter Healthcare Corporation55609586-f0b4-42e6-8dd9-cd090afb5dca2022-07-21Boxed warning, Adverse reactionsExact identifier
unii: 241ATL177A
IntralipidI.V. FAT EMULSIONBaxter Healthcare Corporationa69c82da-15ba-4d4d-8d7f-871dc3981eb82022-07-21Boxed warning, Adverse reactionsExact identifier
unii: 241ATL177A
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
Miracle FootCream LavenderUREA, GLYCERIN, ALOE, DISODIUM EDTAAloe Vera Korea Co.,Ltd.db520c80-2a2a-5eb1-e053-2995a90a5bb42022-03-28WarningsExact identifier
unii: PDC6A3C0OX
Miracle FootCream LemonUREA, GLYCERIN, ALOE, DISODIUM EDTAAloe Vera Korea Co.,Ltd.db525c63-29fd-2033-e053-2995a90a56b92022-03-28WarningsExact identifier
unii: PDC6A3C0OX
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
IntralipidI.V. FAT EMULSIONBaxter Healthcare Corporationcbd3396e-6b85-41bf-82d2-940beba866862019-01-09Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 241ATL177A
Ivy-Dry SuperBENZYL ALCOHOL, CAMPHOR, MENTHOLIvy-Dry, Inc.4792a667-2378-4b3d-968d-9efb1866792f2017-12-27WarningsExact identifier
unii: LKG8494WBH
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
unii: LKG8494WBH

Reported adverse events (FAERS/openFDA)#

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