FDA.reportPublic FDA data

NDC 0078-0630-11 - TOBI Podhaler

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
0078-0630
Requested NDC
0078-0630-11
Package NDCs from labels
0078-0630-11, 0078-0630-56, 0078-0630-35
Manufacturer
Novartis Pharmaceuticals Corporation
Effective date
2020-07-28
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
TOBI Podhaler - Novartis Pharmaceuticals CorporationNovartis Pharmaceuticals Corporation2020-07-28HUMAN PRESCRIPTION DRUG LABEL
National Council for Prescription Drug Programs indexing - billing unitNational Council for Prescription Drug Programs2013-05-02Indexing - Billing Unit

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0078-0630-11EA - Each0078-0630bdcd60f2-d7ce-44f8-9dc5-6d9ad69fd41712013-05-02
0078-0630-19EA - Each0078-0630edfa1a78-7c15-437f-8c76-597abc592e4f12015-05-05
0078-0630-35EA - Each0078-063088c8485a-4212-4b7a-81fd-dfe22f6506ed12013-04-01
0078-0630-56EA - Each0078-0630237e5625-786a-4c89-99e2-e5c3fd491dfd12013-04-01

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TOBRAMYCINACTIVE INGREDIENTVZ8RRZ51VKTOBI PODHALER (TOBRAMYCIN) CAPSULE [NOVARTIS PHARMACEUTICALS CORPORATION]6
TOBRAMYCINACTIVE MOIETYVZ8RRZ51VKTOBI PODHALER (TOBRAMYCIN) CAPSULE [NOVARTIS PHARMACEUTICALS CORPORATION]6
1,2-DISTEAROYL-SN-GLYCERO-3-PHOSPHOCHOLINEINACTIVE INGREDIENT043IPI2M0KTOBI PODHALER (TOBRAMYCIN) CAPSULE [NOVARTIS PHARMACEUTICALS CORPORATION]6
CALCIUM CHLORIDEINACTIVE INGREDIENTM4I0D6VV5MTOBI PODHALER (TOBRAMYCIN) CAPSULE [NOVARTIS PHARMACEUTICALS CORPORATION]6
SULFURIC ACIDINACTIVE INGREDIENTO40UQP6WCFTOBI PODHALER (TOBRAMYCIN) CAPSULE [NOVARTIS PHARMACEUTICALS CORPORATION]6

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 12 · 230 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
calcium chlorideCALCIUM CHLORIDEEskayef Pharmaceuticals Limited5b0bd762-4c87-597e-e063-6394a90a83032026-09-09Warnings, Adverse reactionsExact identifier
unii: M4I0D6VV5M
PollutoxACETONE, ARSENICUM ALBUM, BENZINUM, BERBERIS VULGARIS, CADMIUM SULPHURATUM, CARBON DIOXIDE, CARBONEUM SULPHURATUM, CHLORINUM, HYDROFLUORICUM ACIDUM, MELATONIN, MERCURIUS SOLUBILIS, NITROGENUM OXYGENATUM, NUX VOMICA, OZONE, PETROLEUM, PLUMBUM METALLICUM, STANNUM METALLICUM, SULPHURICUM ACIDUM, TOLUENE, URANIUM NITRICUMDeseret Biologicals, Inc.741fdddf-75af-45a2-9875-ee3b08b0decf2026-09-08WarningsExact identifier
unii: O40UQP6WCF
Calcium ChlorideCALCIUM CHLORIDEREMEDYREPACK INC.801f110c-7800-4689-a37a-f31d99c0f9302026-08-28Adverse reactionsExact identifier
unii: M4I0D6VV5M
Calcium ChlorideCALCIUM CHLORIDE INJECTIONREMEDYREPACK INC.3089499b-142d-482e-889d-1db4da7b11522026-08-26Warnings, Adverse reactionsExact identifier
unii: M4I0D6VV5M
DELFLEXDEXTROSE MONOHYDRATE, SODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDEFresenius Medical Care Renal Therapies Group, LLCbbc5b820-4973-11e2-a192-0002a5d5c51b2026-08-18Warnings, Adverse reactionsExact identifier
unii: M4I0D6VV5M
DELFLEXDEXTROSE MONOHYDRATE, SODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDEFresenius Medical Care Renal Therapies Group, LLCc29bdfa0-4976-11e2-939b-0002a5d5c51b2026-08-18Warnings, Adverse reactionsExact identifier
unii: M4I0D6VV5M
DELFLEXDEXTROSE MONOHYDRATE, SODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDEFresenius Medical Care Renal Therapies Group, LLC515dcee0-3e34-11e2-a25f-0800200c9a662026-08-18Warnings, Adverse reactionsExact identifier
unii: M4I0D6VV5M
PollutoxSULPHURICUM ACIDUM, BERBERIS VULGARIS, ARSENICUM ALBUM, BENZINUM, CADMIUM SULPHURATUM, HYDROFLUORICUM ACIDUM, MELATONIN, NITROGENUM OXYGENATUM, NUX VOMICA, PETROLEUM, PLUMBUM METALLICUM, STANNUM METALLICUM, TOLUENE, ACETONE, CARBON DIOXIDE, CHLORINUM, MERCURIUS SOLUBILIS, OZONE, URANIUM NITRICUMDeseret Biologicals, Inc.e7000300-69ec-47db-8059-3f873d64f1772026-07-31WarningsExact identifier
unii: O40UQP6WCF
TOBRAMYCINTOBRAMYCINLifestar Pharma LLC5563e8af-c6c9-42a2-974d-7d364a47f00a2026-07-29Warnings, Adverse reactionsExact identifier
unii: VZ8RRZ51VK
TOBRAMYCINTOBRAMYCINNorthStar RxLLC7803ac83-1250-451b-8ad8-2c0a343c30312026-07-29Warnings, Adverse reactionsExact identifier
unii: VZ8RRZ51VK
DelflexDEXTROSE MONOHYDRATE, SODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDEFresenius Medical Care de Mexico, S.A. de C.V.a98facd6-9daa-4d37-8209-63a0599dbfaa2026-07-27Warnings, Adverse reactionsExact identifier
unii: M4I0D6VV5M
TobraDexTOBRAMYCIN AND DEXAMETHASONENovartis Pharmaceuticals Corporation7f310e0e-0d3b-493d-b6c4-238493a2a9b92026-07-22Warnings, Adverse reactionsExact identifier
unii: VZ8RRZ51VK
TobramycinTOBRAMYCINPreferred Pharmaceuticals Inc.417623f1-ed48-41f5-a4b4-6f2e4a23891e2026-07-15Warnings, Adverse reactionsExact identifier
unii: VZ8RRZ51VK
Tobramycin Inhalation SolutionTOBRAMYCIN INHALATION SOLUTIONNorthStar RxLLC3d044738-a715-fdee-7849-521e8981e6ec2026-07-09Warnings, Adverse reactionsExact identifier
unii: VZ8RRZ51VK
Tobramycin and DexamethasoneTOBRAMYCIN AND DEXAMETHASONESportpharm LLCfa3d2fda-6857-4ef1-8dae-a2877f7569af2026-07-02Warnings, Adverse reactionsExact identifier
unii: VZ8RRZ51VK
TobramycinTOBRAMYCINSt. Mary's Medical Park Pharmacy9263df93-c558-5d9f-e053-2995a90a546c2026-06-22Warnings, Adverse reactionsExact identifier
unii: VZ8RRZ51VK
BM BM98 DROPSACID SULPH, AMYL NITROSUM, AQUILEGIA, CIMICIFUGA, PULSATILLA, SANGUINARIA, SABINABM Private Limited540bf4ca-c217-1aa1-e063-6394a90ab6402026-06-12WarningsExact identifier
unii: O40UQP6WCF
BM BM98 DROPSACID SULPH, AMYL NITROSUM, AQUILEGIA, CIMICIFUGA, PULSATILLA, SANGUINARIA, SABINATotal Operations Management LLC DBA:Bestmade Natural Products Micro5411fb53-7bd2-d904-e063-6294a90a2c582026-06-12WarningsExact identifier
unii: O40UQP6WCF
Tobramycin and DexamethasoneTOBRAMYCIN AND DEXAMETHASONEREMEDYREPACK INC.c606945c-4ffc-4ee8-af04-a00de8ea92592026-06-11Warnings, Adverse reactionsExact identifier
unii: VZ8RRZ51VK
TOBRAMYCIN AND DEXAMETHASONETOBRAMYCIN AND DEXAMETHASONEBryant Ranch Prepackdf4a7747-8dfa-4933-b4d2-a3d85c5f74f82026-06-08Warnings, Adverse reactionsExact identifier
unii: VZ8RRZ51VK

Reported adverse events (FAERS/openFDA)#

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