FDA.reportPublic FDA data

Octreotide Acetate

Product NDC
67457-246
11-digit product format
674570246
Labeler code
67457
Product ID
67457-246_1bb19829-029a-4baf-a12c-ec04102dd79e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
octreotide acetate
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS; SUBCUTANEOUS
Labeler
Mylan Institutional LLC
Application
ANDA079198
Marketing category
ANDA
Marketing start
2011-04-01
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
Octreotide Acetate
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OCTREOTIDE ACETATE500 ug/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii75R0U2568I
Rxcui1090558, 1090559, 1090560

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
813db1d8-6534-4d2d-be9e-8d2c20a55edaProduct name120241217
a6ddfef5-d553-2919-73fa-8aede2a8ab27Product name520240823
8f3fde6c-976e-4e4c-8ed4-542294fcc0efProduct name120210115
467fba3a-c020-419e-8102-aeb9c0ea15ecProduct name120200616

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67457-246-00Octreotide Acetate1 mL in 1 SYRINGEINJECTION, SOLUTION120
67457-246-01Octreotide Acetate10 in 1 CARTONINJECTION, SOLUTION1020

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
67457-246-00ML - Milliliter67457-24669940b38-68e1-4914-824b-76488336cf1c12013-08-02
67457-246-01ML - Milliliter67457-2466391fba1-462a-4f55-8be9-f37520fe1dbb12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
OCTREOTIDE ACETATEACTIVE INGREDIENT75R0U2568IOCTREOTIDE ACETATE INJECTION, SOLUTION [MYLAN INSTITUTIONAL LLC]6
OCTREOTIDEACTIVE MOIETYRWM8CCW8GPOCTREOTIDE ACETATE INJECTION, SOLUTION [MYLAN INSTITUTIONAL LLC]6
LACTIC ACID, L-INACTIVE INGREDIENTF9S9FFU82NOCTREOTIDE ACETATE INJECTION, SOLUTION [MYLAN INSTITUTIONAL LLC]6
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XOCTREOTIDE ACETATE INJECTION, SOLUTION [MYLAN INSTITUTIONAL LLC]6
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IOCTREOTIDE ACETATE INJECTION, SOLUTION [MYLAN INSTITUTIONAL LLC]6
WATERINACTIVE INGREDIENT059QF0KO0ROCTREOTIDE ACETATE INJECTION, SOLUTION [MYLAN INSTITUTIONAL LLC]6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67457-246OCTREOTIDE ACETATE INJECTION, SOLUTION [MYLAN INSTITUTIONAL LLC]20Current NDC, Legacy NDC, 2 package rows20241215_2d78d5d1-77b2-4da1-98d4-d9c36e743ce2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1090558octreotide 100 MCG in 1 ML Prefilled SyringePSN2d78d5d1-77b2-4da1-98d4-d9c36e743ce220
1090559octreotide 50 MCG in 1 ML Prefilled SyringePSN2d78d5d1-77b2-4da1-98d4-d9c36e743ce220
1090560octreotide 500 MCG in 1 ML Prefilled SyringePSN2d78d5d1-77b2-4da1-98d4-d9c36e743ce220
10905591 ML octreotide 0.05 MG/ML Prefilled SyringeSCD2d78d5d1-77b2-4da1-98d4-d9c36e743ce220
10905581 ML octreotide 0.1 MG/ML Prefilled SyringeSCD2d78d5d1-77b2-4da1-98d4-d9c36e743ce220
10905601 ML octreotide 0.5 MG/ML Prefilled SyringeSCD2d78d5d1-77b2-4da1-98d4-d9c36e743ce220
1090558octreotide (as octreotide acetate) 100 MCG per 1 ML Prefilled SyringeSY2d78d5d1-77b2-4da1-98d4-d9c36e743ce220
1090559octreotide (as octreotide acetate) 50 MCG per 1 ML Prefilled SyringeSY2d78d5d1-77b2-4da1-98d4-d9c36e743ce220
1090560octreotide (as octreotide acetate) 500 MCG per 1 ML Prefilled SyringeSY2d78d5d1-77b2-4da1-98d4-d9c36e743ce220
1090559octreotide 50 MCG per 1 ML Prefilled SyringeSY2d78d5d1-77b2-4da1-98d4-d9c36e743ce220

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67457-246-00674570246001 mL in 1 SYRINGE1 mlHistorical
67457-246-016745702460110 SYRINGE in 1 CARTON (67457-246-01) / 1 mL in 1 SYRINGE (67457-246-00) 10 syringe2011-04-010000-00-00NoNoCurrent