Octreotide Acetate

Product NDC
76135-006
11-digit product format
761350006
Labeler code
76135
Product ID
76135-006_a08b3cbe-bfce-4e7e-9f07-981410c9650f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Octreotide Acetate
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
USV North America Inc.
Application
ANDA203765
Marketing category
ANDA
Marketing start
2019-01-01
Marketing end
0000-00-00
Substance
OCTREOTIDE ACETATE
Active strength
1000 ug/mL
Pharmacologic classes
Somatostatin Analog [EPC],Somatostatin Receptor Agonists [MoA]
NDC exclude flag
No
Listing certified through
2019-12-31
Current FDA listing
Historical FDA.report record

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
76135-006-012020-01-31C16284748780-19d75b9cf-dfe2-f424-e053-dadaa90a57ceRx Only Prescribing Information

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76135-006-01Octreotide Acetate5 mL in 1 VIAL, GLASSINJECTION57

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76135-006OCTREOTIDE ACETATE INJECTION [USV NORTH AMERICA INC.]7Legacy NDC, 1 package rows20190101_6b55eedd-4160-49f8-966b-55b0e60a4b06.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312071octreotide 1000 MCG/ML Injectable SolutionPSN6b55eedd-4160-49f8-966b-55b0e60a4b067
314152octreotide 200 MCG/ML Injectable SolutionPSN6b55eedd-4160-49f8-966b-55b0e60a4b067
314152octreotide 0.2 MG/ML Injectable SolutionSCD6b55eedd-4160-49f8-966b-55b0e60a4b067
312071octreotide 1 MG/ML Injectable SolutionSCD6b55eedd-4160-49f8-966b-55b0e60a4b067
312071octreotide (as octreotide acetate) 1000 MCG/ML Injectable SolutionSY6b55eedd-4160-49f8-966b-55b0e60a4b067
314152octreotide (as octreotide acetate) 200 MCG/ML Injectable SolutionSY6b55eedd-4160-49f8-966b-55b0e60a4b067

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
76135-006-01761350006015 mL in 1 VIAL, GLASS5 mlHistorical