Octreotide Acetate

Product NDC
0703-3311
11-digit product format
007033311
Labeler code
0703
Product ID
0703-3311_2f5b5421-18fe-47d0-8807-b1478eb82b37
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Octreotide Acetate
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS; SUBCUTANEOUS
Labeler
Teva Parenteral Medicines, Inc.
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
2022-12-31
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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0703-3311-01ML - Milliliter0703-331163a0631f-3bd6-43f5-b599-1b2122ff1b5f12012-07-24
0703-3311-04ML - Milliliter0703-33117a8006fb-7d73-4871-b4f0-059f0c9b7fa712012-07-24

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
0703-3311-040070333110425 VIAL, SINGLE-USE in 1 TRAY (0703-3311-04) > 1 mL in 1 VIAL, SINGLE-USE (0703-3311-01) 2005-11-140000-00-00NoNoCurrent