Octreotide Acetate

Product NDC
63629-8831
11-digit product format
636298831
Labeler code
63629
Product ID
63629-8831_5c964434-57fe-4491-8153-969aae896174
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Octreotide Acetate
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS; SUBCUTANEOUS
Labeler
Bryant Ranch Prepack
Application
ANDA075957
Marketing category
ANDA
Marketing start
2005-11-14
Marketing end
0000-00-00
Substance
OCTREOTIDE ACETATE
Active strength
100 ug/mL
Pharmacologic classes
Somatostatin Analog [EPC], Somatostatin Receptor Agonists [MoA]
NDC exclude flag
No
Listing certified through
2023-12-31
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
63629-8831-12024-01-30C16284748780-11030e365-60f5-111a-e063-dadaa90a10e2Octreotide Acetate Injection Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63629-8831-1Octreotide Acetate1 mL in 1 VIAL, SINGLE-USEINJECTION, SOLUTION1101
63629-8831-1Octreotide Acetate25 in 1 TRAYINJECTION, SOLUTION25101

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-8831-1ML - Milliliter63629-8831df9e40d5-92e0-46e2-a73d-7c78ebe1855612021-12-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-8831OCTREOTIDE ACETATE INJECTION, SOLUTION [BRYANT RANCH PREPACK]101Legacy NDC, 2 package rows20220428_dc66e7f9-5879-49b6-b093-e31fd2afbe8c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312069octreotide 100 MCG in 1 ML InjectionPSNdc66e7f9-5879-49b6-b093-e31fd2afbe8c101
3120691 ML octreotide 0.1 MG/ML InjectionSCDdc66e7f9-5879-49b6-b093-e31fd2afbe8c101
3120691 ML octreotide 100 MCG/ML InjectionSYdc66e7f9-5879-49b6-b093-e31fd2afbe8c101
312069octreotide 100 MCG per 1 ML InjectionSYdc66e7f9-5879-49b6-b093-e31fd2afbe8c101

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63629-8831-16362988310125 VIAL, SINGLE-USE in 1 TRAY (63629-8831-1) > 1 mL in 1 VIAL, SINGLE-USE2021-09-100000-00-00NoNoCurrent