FDA.reportPublic FDA data

NDC 60505-0577-03 - Brimonidine Tartrate

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
60505-0577
Requested NDC
60505-0577-03
Package NDCs from labels
60505-0577-1, 60505-0577-2, 60505-0577-3, 60505-0577-03
Manufacturer
Apotex Corp.
Effective date
2026-09-09
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Brimonidine Tartrate - Apotex Corp.Apotex Corp.2026-09-09HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
60505-0577-1Brimonidine Tartrate5 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS54
60505-0577-1Brimonidine Tartrate1 in 1 CARTONSOLUTION/ DROPS14
60505-0577-2Brimonidine Tartrate1 in 1 CARTONSOLUTION/ DROPS14
60505-0577-2Brimonidine Tartrate10 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS104
60505-0577-3Brimonidine Tartrate15 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS154
60505-0577-3Brimonidine Tartrate1 in 1 CARTONSOLUTION/ DROPS14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60505-0577BRIMONIDINE TARTRATE SOLUTION/ DROPS [APOTEX CORP.]2Current NDC, 6 package rows20240921_e08a915a-77ca-4d16-d760-11b05848418d.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60505-0577-1ML - Milliliter60505-0577801b94bd-8d76-4432-ac1c-5fe75db9b55912023-09-05
60505-0577-2ML - Milliliter60505-0577e41f3765-9cd1-4863-b07e-9951f1a0eb8112023-09-05
60505-0577-3ML - Milliliter60505-057708704854-89ca-4b0c-afc7-1b71bf46431712023-09-05

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 1 of 82 · 1,622 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Lymph Tonic IIECHINACEA (ANGUSTIFOLIA), COLLINSONIA CANADENSIS, PHYTOLACCA DECANDRA, KALI IODATUM, PINUS SYLVESTRIS, PIX LIQUIDA, FERRUM PHOSPHORICUM, AESCULUS HIPPOCASTANUM, BARYTA CARBONICA, BERBERIS VULGARIS, CALCAREA CARBONICA, CALCAREA PHOSPHORICA, CAUSTICUM, HEPAR SULPHURIS CALCAREUM, KREOSOTUM, LYCOPODIUM CLAVATUM, MERCURIUS SOLUBILIS, NATRUM MURIATICUM, NITRICUM ACIDUM, PHOSPHORUS, PULSATILLA (PRATENSIS), SILICEA, STELLARIA MEDIA, SULPHUR, TEREBINTHINA, THUJA OCCIDENTALIS, BUFO RANABioActive Nutritional, Inc.0e3265b0-b210-4a4c-80d2-8a9712981d4e2026-09-17WarningsExact identifier
unii: 451W47IQ8X
calcium chlorideCALCIUM CHLORIDEEskayef Pharmaceuticals Limited5b0bd762-4c87-597e-e063-6394a90a83032026-09-09Warnings, Adverse reactionsExact identifier
unii: M4I0D6VV5M
Potassium Chloride Extended-releasePOTASSIUM CHLORIDE EXTENDED-RELEASEREMEDYREPACK INC.ace1eb11-b925-405a-b772-58c60b3ca7d42026-09-09Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
SalineNASALRaritan Pharmaceuiticals Inc4b178e4e-a10f-4b75-8140-1f7548e203ad2026-09-09WarningsExact identifier
unii: 451W47IQ8X
Brimonidine TartrateBRIMONIDINE TARTRATEApotex Corp.e08a915a-77ca-4d16-d760-11b05848418d2026-09-09Warnings, Adverse reactionsExact identifier
application number: ANDA078480
ndc (package): 60505-0577-1
ndc (package): 60505-0577-3
ndc (package): 60505-0577-2
ndc (product): 60505-0577
ndc11 (package): 60505057703
rxcui: 861204
spl id: b0924316-6a82-4b85-f397-a82fd49da653
spl set id: e08a915a-77ca-4d16-d760-11b05848418d
unii: 4S9CL2DY2H
Thyroid SupportCALCAREA CARBONICA, CALCAREA IODATA, CAUSTICUM, FERRUM IODATUM, FUCUS VESICULOSUS, KALI IODATUM, NATRUM MURIATICUM, THYROIDINUM (BOVINE)NaturalCare07b4e0ed-2b00-4d0a-ad8f-fc6deff153252026-09-08WarningsExact identifier
unii: 451W47IQ8X
Nerve Guard Nerve ReliefLIDOCAINE HYDROCHLORIDE, MENTHOL,MAGNESIUM CHLORIDEMicelle Laboratories, Incorporated6b78f40f-2a7f-4c49-96af-1a95acbf430f2026-09-04WarningsExact identifier
unii: 02F3473H9O
Psoriasis ControlCENTELLA ASIATICA, SODIUM CHLORIDE, AND SILICON DIOXIDEForces of Nature2db33771-0bb9-49f8-84fa-dddc28e4ba262026-09-04WarningsExact identifier
unii: 451W47IQ8X
Brimonidine Tartrate Ophthalmic SolutionBRIMONIDINE TARTRATE OPHTHALMIC SOLUTIONLifestar Pharma LLCf6666d85-f810-4869-993d-e8ae35b4517f2026-09-03Warnings, Adverse reactionsExact identifier
rxcui: 861204
unii: 4S9CL2DY2H
KROGER SalineNASALKROGER COMPANYc84b242b-f46e-4ea8-a3c1-109a476446462026-09-02WarningsExact identifier
unii: 451W47IQ8X
Adrenal SupportADRENALINUM, ARGENTUM NITRICUM, BERBERIS VULGARIS, NATRUM MURIATICUM, OLEUM MORRHUAE, PETROLEUM, VANADIUMNaturalCare31a5d522-15cd-432a-bf87-f721bcbe2e312026-09-02WarningsExact identifier
unii: 451W47IQ8X
Xtreme Saline Rinse MixSODIUM BICARBONATE, SODIUM CHLORIDEXtreme Personal Care Inc776f417e-e443-4918-8c7a-1913b7dddcd42026-09-01WarningsExact identifier
unii: 451W47IQ8X
Pharmlitalia Vaginal Symptoms ReliefBORAX,CALENDULA OFFICINALIS,HYDRASTIS CANADENSIS,OLIVE EXTRACTGuangzhou Trading Financing Union LLCad63f5aa-dfa7-4773-bec2-12ccf8181f952026-09-01WarningsExact identifier
unii: 91MBZ8H3QO
Nacl 0.9% Normal Saline SolutionSODIUM CHLORIDECHI FUNG TECHNOLOGY COMPANY5a53c4c8-c9de-700c-e063-6394a90a3ab52026-08-31WarningsExact identifier
unii: 451W47IQ8X
BMNP Kali MurKALIUM MURIATICUMTotal Operations Management LLC DBA:Bestmade Natural Products Micro5a546950-3f03-7abf-e063-6294a90a19682026-08-31WarningsExact identifier
unii: 660YQ98I10
BMNP Nat MurNATRUM MURIATICUMTotal Operations Management LLC DBA:Bestmade Natural Products Micro5a57ccfd-ab6f-cb2c-e063-6394a90ae9e62026-08-31WarningsExact identifier
unii: 451W47IQ8X
Calcium ChlorideCALCIUM CHLORIDEREMEDYREPACK INC.801f110c-7800-4689-a37a-f31d99c0f9302026-08-28Adverse reactionsExact identifier
unii: M4I0D6VV5M
Allergy CareADRENALINUM, RAGWEED, POLLEN (AMBROSIA ARTEMISIAEFOLIA), APIS MELLIFICA, ECHINACEA (ANGUSTIFOLIA), HISTAMINUM HYDROCHLORICUM, LEDUM PALUSTRE, LYCOPODIUM CLAVATUM, NATRUM MURIATICUM, SULPHURNaturalCaref3ca7f5a-1448-4670-ac02-b47ffb6c55852026-08-27WarningsExact identifier
unii: 451W47IQ8X
Potassium Chloride Extended-releasePOTASSIUM CHLORIDE EXTENDED-RELEASEREMEDYREPACK INC.2c407aaf-5d95-49ff-a5db-f1d7b51903342026-08-27Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
Calcium ChlorideCALCIUM CHLORIDE INJECTIONREMEDYREPACK INC.3089499b-142d-482e-889d-1db4da7b11522026-08-26Warnings, Adverse reactionsExact identifier
unii: M4I0D6VV5M

Reported adverse events (FAERS/openFDA)#

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