FDA.reportPublic FDA data

NDC 0078-0182-61 - Sandostatin

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
0078-0182
Requested NDC
0078-0182-61
Package NDCs from labels
0078-0182-61, 0078-0182-01
Manufacturer
Novartis Pharmaceuticals Corporation
Effective date
2026-07-22
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Sandostatin - Novartis Pharmaceuticals CorporationNovartis Pharmaceuticals Corporation2026-07-22HUMAN PRESCRIPTION DRUG LABEL
National Council for Prescription Drug Programs indexing - billing unitNational Council for Prescription Drug Programs2013-02-13Indexing - Billing Unit

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0078-0182-01Sandostatin10 in 1 PACKAGEINJECTION, SOLUTION1022
0078-0182-61Sandostatin1 mL in 1 AMPULEINJECTION, SOLUTION122

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0078-0182SANDOSTATIN (OCTREOTIDE ACETATE) INJECTION, SOLUTION [NOVARTIS PHARMACEUTICALS CORPORATION]21Current NDC, Legacy NDC, 2 package rows20250122_4e2c9856-1836-49f0-9472-4dbeeb408f39.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0078-0182-01ML - Milliliter0078-0182bd523ca5-34ba-47f2-a31d-fac6262b0dda12012-07-24
0078-0182-61ML - Milliliter0078-0182742db355-5848-416a-bcf4-e083b33a56e212013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
OCTREOTIDE ACETATEACTIVE INGREDIENT75R0U2568ISANDOSTATIN (OCTREOTIDE ACETATE) INJECTION, SOLUTION [NOVARTIS PHARMACEUTICALS CORPORATION]7
OCTREOTIDEACTIVE MOIETYRWM8CCW8GPSANDOSTATIN (OCTREOTIDE ACETATE) INJECTION, SOLUTION [NOVARTIS PHARMACEUTICALS CORPORATION]7
LACTIC ACIDINACTIVE INGREDIENT33X04XA5ATSANDOSTATIN (OCTREOTIDE ACETATE) INJECTION, SOLUTION [NOVARTIS PHARMACEUTICALS CORPORATION]7
MANNITOLINACTIVE INGREDIENT3OWL53L36ASANDOSTATIN (OCTREOTIDE ACETATE) INJECTION, SOLUTION [NOVARTIS PHARMACEUTICALS CORPORATION]7
PHENOLINACTIVE INGREDIENT339NCG44TVSANDOSTATIN (OCTREOTIDE ACETATE) INJECTION, SOLUTION [NOVARTIS PHARMACEUTICALS CORPORATION]7
SODIUM BICARBONATEINACTIVE INGREDIENT8MDF5V39QOSANDOSTATIN (OCTREOTIDE ACETATE) INJECTION, SOLUTION [NOVARTIS PHARMACEUTICALS CORPORATION]7
WATERINACTIVE INGREDIENT059QF0KO0RSANDOSTATIN (OCTREOTIDE ACETATE) INJECTION, SOLUTION [NOVARTIS PHARMACEUTICALS CORPORATION]7

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 21 · 408 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Xtreme Saline Rinse MixSODIUM BICARBONATE, SODIUM CHLORIDEXtreme Personal Care Inc776f417e-e443-4918-8c7a-1913b7dddcd42026-09-01WarningsExact identifier
unii: 8MDF5V39QO
Sodium BicarbonateSODIUM BICARBONATEREMEDYREPACK INC.96093b76-5d98-4d2b-b851-20207a8864db2026-08-28Warnings, Adverse reactionsExact identifier
unii: 8MDF5V39QO
KUGIG ALOE FOAMING INTIMATE WASHINTIMATE CLEANSING FOAMHong Kong KangXing Centennial Management Limited59f4d398-1186-a168-e063-6294a90ab44b2026-08-26WarningsExact identifier
unii: 059QF0KO0R
Sodium BicarbonateSODIUM BICARBONATEExela Pharma Sciences, LLCf8806ec3-a1c0-47a9-9660-2628dca4623e2026-08-25Warnings, Adverse reactionsExact identifier
unii: 8MDF5V39QO
Sterile WaterWATERREMEDYREPACK INC.5dd5d148-6e23-41de-bff5-551b2aea95982026-08-24Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
omeprazole and sodium bicarbonateOMEPRAZOLE, SODIUM BICARBONATEAmazon.com Services LLCbb453f26-c7df-4cce-8793-337cb5d5f9a92026-08-19WarningsExact identifier
unii: 8MDF5V39QO
BM BM63 DROPSCEANOTHUS, KALI ARSEN, KALI MUR, SELENIUM, THALLIUM, WIESBADENBM Private Limited59006d82-610a-2e08-e063-6394a90af1ed2026-08-14WarningsExact identifier
unii: 059QF0KO0R
sodium bicarbonateSODIUM BICARBONATEBaxter Healthcare Corporationb50c858a-00c8-4cb2-ad73-8797f19e656d2026-08-14Warnings, Adverse reactionsExact identifier
unii: 8MDF5V39QO
Sodium BicarbonateSODIUM BICARBONATEMilla Pharmaceuticals Inc.2d2035c2-e41b-4d57-a23c-fae16ad9a3552026-08-07Warnings, Adverse reactionsExact identifier
unii: 8MDF5V39QO
Sterile WaterWATERCardinal Health 107, LLC48d75a7c-8329-48a8-bea0-a8c144ddf6372026-08-07Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Sodium Bicarbonate 5 grSODIUM BICARBONATETWIN MED LLCe325d899-d9a6-5adb-e053-2995a90ac8612026-08-04WarningsExact identifier
unii: 8MDF5V39QO
GarzulysINSULIN ASPART-FSANMeitheal Pharmaceuticals Inc.30c64769-d2f7-4604-ac9e-2a6bc09506c92026-07-31Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
DECONIMO ReconstitutionDECONIMO RECONSTITUTIONImage Amazon LLC57ab9b1c-9a18-3786-e063-6394a90a2c632026-07-28WarningsExact identifier
unii: 059QF0KO0R
DERMFREE INSECT BITE RELIEFSODIUM BICARBONATE 5% INSECT BITE RELIEFWenzhou Yuyuan Pharmaceutical Co., Ltd.5794886c-0d74-9f35-e063-6394a90a27d82026-07-27WarningsExact identifier
unii: 8MDF5V39QO
PEG 3350 and ElectrolytesPOLYETHYLENE GLYCOL 3350, SODIUM SULFATE ANHYDROUS, SODIUM BICARBONATE, SODIUM CHLORIDE, POTASSIUM CHLORIDEA-S Medication Solutions19daf830-7270-4661-81b1-ded38f867f282026-07-24Warnings, Adverse reactionsExact identifier
unii: 8MDF5V39QO
PRENATE RestoreASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, DL-, FOLIC ACID, PYRIDOXINE HYDROCHLORIDE, CYANOCOBALAMIN, BIOTIN, CALCIUM CARBONATE, FERROUS FUMARATE, MAGNESIUM OXIDE, LACTIC ACID AND DOCONEXENTAvion Pharmaceuticals, LLC1076ba9a-0168-492f-ba9b-99fa021860922026-07-23Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 33X04XA5AT
SandostatinOCTREOTIDE ACETATENovartis Pharmaceuticals Corporation4e2c9856-1836-49f0-9472-4dbeeb408f392026-07-22Warnings, Adverse reactionsExact identifier
application number: NDA019667
ndc (package): 0078-0180-61
ndc (package): 0078-0180-01
ndc (package): 0078-0182-01
ndc (package): 0078-0182-61
ndc (package): 0078-0181-61
ndc (package): 0078-0181-01
ndc (product): 0078-0180
ndc (product): 0078-0182
ndc (product): 0078-0181
ndc11 (package): 00078018261
rxcui: 312070
rxcui: 312069
rxcui: 207200
rxcui: 312068
rxcui: 207198
rxcui: 207194
spl id: 3f1a424d-05a3-40d6-8127-44948e411611
spl set id: 4e2c9856-1836-49f0-9472-4dbeeb408f39
unii: 75R0U2568I
Sterile WaterWATERCardinal Health 107, LLC9655cd02-82b5-4a75-813b-854b195514812026-07-21Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Sodium BicarbonateSODIUM BICARBONATEAmneal Pharmaceuticals Private Limitedac91e834-e693-43a2-829b-56793453e8cc2026-07-09Warnings, Adverse reactionsExact identifier
unii: 8MDF5V39QO
Dr. Drop NMN Vital Balance (Drop No.1 Cream 90g)NMN (NICOTINAMIDE MONONUCLEOTIDE), ECTOIN (ECTOINE)Reedfresh Co., LTD55d703ca-ff9d-0dbc-e063-6294a90ab6b12026-07-05WarningsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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