FDA.reportPublic FDA data

Octreotide

Product NDC
63323-376
11-digit product format
633230376
Labeler code
63323
Product ID
63323-376_02ac0091-573d-41ba-8b4d-5a1d42b89b2e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
OCTREOTIDE ACETATE
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS; SUBCUTANEOUS
Labeler
Fresenius Kabi USA, LLC
Application
ANDA077457
Marketing category
ANDA
Marketing start
2006-03-14
Substance
OCTREOTIDE ACETATE
Active strength
100 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
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OCTREOTIDE ACETATE100 ug/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii75R0U2568I
Rxcui312069, 312070, 312071, 314152

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
813db1d8-6534-4d2d-be9e-8d2c20a55edaProduct name120241217
a6ddfef5-d553-2919-73fa-8aede2a8ab27Product name520240823
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
8f3fde6c-976e-4e4c-8ed4-542294fcc0efProduct name120210115
467fba3a-c020-419e-8102-aeb9c0ea15ecProduct name120200616
48747306-602a-42cc-957b-5b0c69158eeeProduct name120180604
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
db5ebcdb-b6ae-21cd-4dc5-76cd84b5578bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63323-376-00Octreotide1 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION19
63323-376-01Octreotide10 in 1 TRAYINJECTION, SOLUTION109
63323-376-04Octreotide10 in 1 TRAYINJECTION, SOLUTION106
63323-376-41Octreotide1 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION16

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63323-376-00ML - Milliliter63323-37651d074e4-06a9-44dc-a446-26557b04ada912023-03-13
63323-376-01ML - Milliliter63323-37632811785-7b28-4627-960a-da0581df10cc12013-02-13
63323-376-04ML - Milliliter63323-376b4593d3f-2e5d-43c9-8524-910446c0347d12014-08-01
63323-376-41ML - Milliliter63323-37651911689-cd27-43be-b37a-453862e34b4d12022-03-09

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
OCTREOTIDE ACETATEACTIVE INGREDIENT75R0U2568IOCTREOTIDE (OCTREOTIDE ACETATE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]2
OCTREOTIDE ACETATEACTIVE INGREDIENT75R0U2568IOCTREOTIDE (OCTREOTIDE ACETATE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]2
OCTREOTIDEACTIVE MOIETYRWM8CCW8GPOCTREOTIDE (OCTREOTIDE ACETATE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]2
OCTREOTIDEACTIVE MOIETYRWM8CCW8GPOCTREOTIDE (OCTREOTIDE ACETATE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]2
ACETIC ACIDINACTIVE INGREDIENTQ40Q9N063POCTREOTIDE (OCTREOTIDE ACETATE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]2
ACETIC ACIDINACTIVE INGREDIENTQ40Q9N063POCTREOTIDE (OCTREOTIDE ACETATE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]2
PHENOLINACTIVE INGREDIENT339NCG44TVOCTREOTIDE (OCTREOTIDE ACETATE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]2
SODIUM ACETATEINACTIVE INGREDIENT4550K0SC9BOCTREOTIDE (OCTREOTIDE ACETATE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]2
SODIUM ACETATEINACTIVE INGREDIENT4550K0SC9BOCTREOTIDE (OCTREOTIDE ACETATE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]2
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XOCTREOTIDE (OCTREOTIDE ACETATE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]2
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XOCTREOTIDE (OCTREOTIDE ACETATE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63323-376OCTREOTIDE (OCTREOTIDE ACETATE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]9Current NDC, Legacy NDC, 2 package rows20240518_f278f0d8-4062-420a-97c3-3a8b88253a08.zip
63323-376OCTREOTIDE (OCTREOTIDE ACETATE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC ]6Current NDC, Legacy NDC, 2 package rows20240530_d6a9a800-889d-417f-b533-1913197d0022.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312069octreotide 100 MCG in 1 ML InjectionPSNf278f0d8-4062-420a-97c3-3a8b88253a089
312071octreotide 1000 MCG/ML Injectable SolutionPSNf278f0d8-4062-420a-97c3-3a8b88253a089
314152octreotide 200 MCG/ML Injectable SolutionPSNf278f0d8-4062-420a-97c3-3a8b88253a089
312070octreotide 500 MCG in 1 ML InjectionPSNf278f0d8-4062-420a-97c3-3a8b88253a089
3120691 ML octreotide 0.1 MG/ML InjectionSCDf278f0d8-4062-420a-97c3-3a8b88253a089
3120701 ML octreotide 0.5 MG/ML InjectionSCDf278f0d8-4062-420a-97c3-3a8b88253a089
314152octreotide 0.2 MG/ML Injectable SolutionSCDf278f0d8-4062-420a-97c3-3a8b88253a089
312071octreotide 1 MG/ML Injectable SolutionSCDf278f0d8-4062-420a-97c3-3a8b88253a089
3120691 ML octreotide 100 MCG/ML InjectionSYf278f0d8-4062-420a-97c3-3a8b88253a089
3120701 ML octreotide 500 MCG/ML InjectionSYf278f0d8-4062-420a-97c3-3a8b88253a089
312071octreotide (as octreotide acetate) 1000 MCG/ML Injectable SolutionSYf278f0d8-4062-420a-97c3-3a8b88253a089
314152octreotide (as octreotide acetate) 200 MCG/ML Injectable SolutionSYf278f0d8-4062-420a-97c3-3a8b88253a089
312069octreotide 100 MCG per 1 ML InjectionSYf278f0d8-4062-420a-97c3-3a8b88253a089
312070octreotide 500 MCG per 1 ML InjectionSYf278f0d8-4062-420a-97c3-3a8b88253a089
312069octreotide 100 MCG in 1 ML InjectionPSNd6a9a800-889d-417f-b533-1913197d00226
312070octreotide 500 MCG in 1 ML InjectionPSNd6a9a800-889d-417f-b533-1913197d00226
3120691 ML octreotide 0.1 MG/ML InjectionSCDd6a9a800-889d-417f-b533-1913197d00226
3120701 ML octreotide 0.5 MG/ML InjectionSCDd6a9a800-889d-417f-b533-1913197d00226
3120691 ML octreotide 100 MCG/ML InjectionSYd6a9a800-889d-417f-b533-1913197d00226
3120701 ML octreotide 500 MCG/ML InjectionSYd6a9a800-889d-417f-b533-1913197d00226
312069octreotide 100 MCG per 1 ML InjectionSYd6a9a800-889d-417f-b533-1913197d00226
312070octreotide 500 MCG per 1 ML InjectionSYd6a9a800-889d-417f-b533-1913197d00226

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63323-376-00633230376001 mL in 1 VIAL, SINGLE-DOSE1 mlHistorical
63323-376-016332303760110 VIAL, SINGLE-DOSE in 1 TRAY (63323-376-01) / 1 mL in 1 VIAL, SINGLE-DOSE (63323-376-00) 2006-03-140000-00-00NoNoCurrent
63323-376-046332303760410 VIAL, SINGLE-DOSE in 1 TRAY (63323-376-04) / 1 mL in 1 VIAL, SINGLE-DOSE (63323-376-41) 2006-03-140000-00-00NoNoCurrent
63323-376-41633230376411 mL in 1 VIAL, SINGLE-DOSE1 mlHistorical