FDA.reportPublic FDA data

Sandostatin

Product NDC
0078-0182
11-digit product format
000780182
Labeler code
0078
Product ID
0078-0182_ad42b59d-8ad5-4855-96a9-f40c7ef4a7e3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
octreotide acetate
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS; SUBCUTANEOUS
Labeler
Novartis Pharmaceuticals Corporation
Application
NDA019667
Marketing category
NDA
Marketing start
1988-10-21
Substance
OCTREOTIDE ACETATE
Active strength
500 ug/mL
Pharmacologic classes
Somatostatin Analog [EPC], Somatostatin Receptor Agonists [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Sandostatin
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OCTREOTIDE ACETATE500 ug/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii75R0U2568I
Rxcui207194, 207198, 207200, 312068, 312069, 312070

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
813db1d8-6534-4d2d-be9e-8d2c20a55edaProduct name120241217
a6ddfef5-d553-2919-73fa-8aede2a8ab27Product name520240823
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
8f3fde6c-976e-4e4c-8ed4-542294fcc0efProduct name120210115
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
467fba3a-c020-419e-8102-aeb9c0ea15ecProduct name120200616
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
597b1cfd-7b31-5048-62be-ca5cd740da2fProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

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 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

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 RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312069octreotide 100 MCG in 1 ML InjectionPSN4e2c9856-1836-49f0-9472-4dbeeb408f3922
312068octreotide 50 MCG in 1 ML InjectionPSN4e2c9856-1836-49f0-9472-4dbeeb408f3922
312070octreotide 500 MCG in 1 ML InjectionPSN4e2c9856-1836-49f0-9472-4dbeeb408f3922
207198SandoSTATIN 100 MCG in 1 ML InjectionPSN4e2c9856-1836-49f0-9472-4dbeeb408f3922
207194SandoSTATIN 50 MCG in 1 ML InjectionPSN4e2c9856-1836-49f0-9472-4dbeeb408f3922
207200SandoSTATIN 500 MCG in 1 ML InjectionPSN4e2c9856-1836-49f0-9472-4dbeeb408f3922
2071941 ML octreotide 0.05 MG/ML Injection [Sandostatin]SBD4e2c9856-1836-49f0-9472-4dbeeb408f3922
2071981 ML octreotide 0.1 MG/ML Injection [Sandostatin]SBD4e2c9856-1836-49f0-9472-4dbeeb408f3922
2072001 ML octreotide 0.5 MG/ML Injection [Sandostatin]SBD4e2c9856-1836-49f0-9472-4dbeeb408f3922
3120681 ML octreotide 0.05 MG/ML InjectionSCD4e2c9856-1836-49f0-9472-4dbeeb408f3922
3120691 ML octreotide 0.1 MG/ML InjectionSCD4e2c9856-1836-49f0-9472-4dbeeb408f3922
3120701 ML octreotide 0.5 MG/ML InjectionSCD4e2c9856-1836-49f0-9472-4dbeeb408f3922
3120691 ML octreotide 100 MCG/ML InjectionSY4e2c9856-1836-49f0-9472-4dbeeb408f3922
3120701 ML octreotide 500 MCG/ML InjectionSY4e2c9856-1836-49f0-9472-4dbeeb408f3922
2071941 ML Sandostatin 0.05 MG/ML InjectionSY4e2c9856-1836-49f0-9472-4dbeeb408f3922
2071981 ML Sandostatin 0.1 MG/ML InjectionSY4e2c9856-1836-49f0-9472-4dbeeb408f3922
2072001 ML Sandostatin 0.5 MG/ML InjectionSY4e2c9856-1836-49f0-9472-4dbeeb408f3922
312069octreotide 100 MCG per 1 ML InjectionSY4e2c9856-1836-49f0-9472-4dbeeb408f3922
312068octreotide 50 MCG per 1 ML InjectionSY4e2c9856-1836-49f0-9472-4dbeeb408f3922
312070octreotide 500 MCG per 1 ML InjectionSY4e2c9856-1836-49f0-9472-4dbeeb408f3922
207198Sandostatin 100 MCG per 1 ML InjectionSY4e2c9856-1836-49f0-9472-4dbeeb408f3922
207200Sandostatin 500 MCG per 1 ML InjectionSY4e2c9856-1836-49f0-9472-4dbeeb408f3922

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0078-0182-010007801820110 AMPULE in 1 PACKAGE (0078-0182-01) / 1 mL in 1 AMPULE (0078-0182-61) 10 ampule1988-10-210000-00-00NoNoCurrent
0078-0182-61000780182611 mL in 1 AMPULE1 mlHistorical