Home NDC 67457-759 OCTREOTIDE ACETATE
Product NDC 67457-759
11-digit product format 674570759
Labeler code 67457
Product ID 67457-759_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 Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A216589-001 OCTREOTIDE ACETATE OCTREOTIDE ACETATE EQ 10MG BASE/VIAL INJECTABLE / INJECTION AB 2025-12-12 A216589-002 OCTREOTIDE ACETATE OCTREOTIDE ACETATE EQ 20MG BASE/VIAL INJECTABLE / INJECTION AB 2025-12-12 A216589-003 OCTREOTIDE ACETATE OCTREOTIDE ACETATE EQ 30MG BASE/VIAL INJECTABLE / INJECTION AB 2025-12-12
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 matching rows.
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 3 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration A216589-001 CGT 2026-08-02 A216589-002 CGT 2026-07-27 A216589-003 CGT 2026-07-27
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 A216589-001 OCTREOTIDE ACETATE EQ 10MG BASE/VIAL INJECTABLE / INJECTION AB 2025-12-12 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A216589-002 OCTREOTIDE ACETATE EQ 20MG BASE/VIAL INJECTABLE / INJECTION AB 2025-12-12 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A216589-003 OCTREOTIDE ACETATE EQ 30MG BASE/VIAL INJECTABLE / INJECTION AB 2025-12-12 011fe1cb6892…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A216589-001 OCTREOTIDE ACETATE EQ 10MG BASE/VIAL INJECTABLE / INJECTION AB 2025-12-12 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A216589-002 OCTREOTIDE ACETATE EQ 20MG BASE/VIAL INJECTABLE / INJECTION AB 2025-12-12 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A216589-003 OCTREOTIDE ACETATE EQ 30MG BASE/VIAL INJECTABLE / INJECTION AB 2025-12-12 a50c72e98297…
Observed Orange Book normalized TE history# Observed Orange Book exclusivity history# Captured, Edition, Application-product table Captured Edition Application-product Exclusivity code Expiration Source SHA-256 2026-02-19 14:30 UTC 2026-02 A216589-001 CGT 2026-08-02 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A216589-002 CGT 2026-07-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A216589-003 CGT 2026-07-27 011fe1cb6892…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A216589-001 CGT 2026-08-02 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A216589-002 CGT 2026-07-27 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A216589-003 CGT 2026-07-27 a50c72e98297…
Additional Listing Data#
Finished product Yes
Brand name base OCTREOTIDE ACETATE
Listing expiration 2027-12-31 Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 898589 Internal RxNorm lookup 898601 Internal RxNorm lookup 898605 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 67457-759-20 OCTREOTIDE ACETATE 1 in 1 KIT KIT 1 1
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 67457-759-20 67457075920 1 KIT in 1 KIT (67457-759-20) * 6 mL in 1 VIAL (67457-757-20) * 2 mL in 1 SYRINGE (67457-758-02) 1 kit 2026-01-28 No No Current