FDA.reportPublic FDA data

OCTREOTIDE ACETATE

Product NDC
67457-756
11-digit product format
674570756
Labeler code
67457
Product ID
67457-756_e5c21813-4714-4f23-be8b-765bd58f63b3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
OCTREOTIDE ACETATE
Dosage form
KIT
Labeler
Mylan Institutional LLC
Application
ANDA216589
Marketing category
ANDA
Marketing start
2026-01-28
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
OCTREOTIDE ACETATE
Listing expiration
2027-12-31

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
67457-756-10OCTREOTIDE ACETATE1 in 1 KITKIT11

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
67457-756-10EA - Each67457-7567d60bcdb-b00c-4572-b79f-b2d2f41c634e12026-02-05

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
898605octreotide LAR 10 MG InjectionPSNe5c21813-4714-4f23-be8b-765bd58f63b31
898589octreotide LAR 20 MG InjectionPSNe5c21813-4714-4f23-be8b-765bd58f63b31
898601octreotide LAR 30 MG InjectionPSNe5c21813-4714-4f23-be8b-765bd58f63b31
898605octreotide 10 MG InjectionSCDe5c21813-4714-4f23-be8b-765bd58f63b31
898589octreotide 20 MG InjectionSCDe5c21813-4714-4f23-be8b-765bd58f63b31
898601octreotide 30 MG InjectionSCDe5c21813-4714-4f23-be8b-765bd58f63b31
898605octreotide (as octreotide acetate) 10 MG InjectionSYe5c21813-4714-4f23-be8b-765bd58f63b31
898589octreotide (as octreotide acetate) 20 MG InjectionSYe5c21813-4714-4f23-be8b-765bd58f63b31
898601octreotide (as octreotide acetate) 30 MG InjectionSYe5c21813-4714-4f23-be8b-765bd58f63b31

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
67457-756-10674570756101 KIT in 1 KIT (67457-756-10) * 6 mL in 1 VIAL (67457-754-10) * 2 mL in 1 SYRINGE (67457-755-02) 1 kit2026-01-28NoNoCurrent