Octreotide Acetate

Product NDC
0480-9257
11-digit product format
004809257
Labeler code
0480
Product ID
0480-9257_2e77a034-b0ae-4694-8ac0-ae1319754d3a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Octreotide Acetate
Dosage form
KIT
Route
INTRAMUSCULAR
Labeler
Teva Pharmaceuticals, Inc.
Application
ANDA210317
Marketing category
ANDA
Marketing start
2025-03-20
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

Harmonized Identifiers#

Field, Values table
FieldValues
Rxcui898589, 898601, 898605

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
0480-9257-08Octreotide Acetate1 in 1 KITKIT15

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0480-9257-08EA - Each0480-92574468114e-2317-404f-b53e-6439076671c812025-05-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0480-9257OCTREOTIDE ACETATE KIT [TEVA PHARMACEUTICALS, INC.]5Current NDC, 1 package rows20250323_d9739ea6-74de-4a41-a806-6e827a23cedb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
898605octreotide LAR 10 MG InjectionPSNd9739ea6-74de-4a41-a806-6e827a23cedb5
898589octreotide LAR 20 MG InjectionPSNd9739ea6-74de-4a41-a806-6e827a23cedb5
898601octreotide LAR 30 MG InjectionPSNd9739ea6-74de-4a41-a806-6e827a23cedb5
898605octreotide 10 MG InjectionSCDd9739ea6-74de-4a41-a806-6e827a23cedb5
898589octreotide 20 MG InjectionSCDd9739ea6-74de-4a41-a806-6e827a23cedb5
898601octreotide 30 MG InjectionSCDd9739ea6-74de-4a41-a806-6e827a23cedb5
898605octreotide (as octreotide acetate) 10 MG InjectionSYd9739ea6-74de-4a41-a806-6e827a23cedb5
898589octreotide (as octreotide acetate) 20 MG InjectionSYd9739ea6-74de-4a41-a806-6e827a23cedb5
898601octreotide (as octreotide acetate) 30 MG InjectionSYd9739ea6-74de-4a41-a806-6e827a23cedb5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0480-9257-08004809257081 KIT in 1 KIT (0480-9257-08) * 8 mL in 1 VIAL, SINGLE-DOSE (0480-9256-01) * 2 mL in 1 SYRINGE (0480-9263-21) 1 kit2025-03-20NoNoHistorical