Home NDC 0078-0825 Sandostatin LAR Depot
Product NDC 0078-0825
11-digit product format 000780825
Labeler code 0078
Product ID 0078-0825_2a2ad59f-21cd-4734-9c4b-0154e9db1642
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name octreotide acetate
Dosage form KIT
Labeler Novartis Pharmaceuticals Corporation
Application NDA021008
Marketing category NDA
Marketing start 2016-07-22
NDC exclude flag No
Listing certified through 2026-12-31
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 N021008-001 SANDOSTATIN LAR OCTREOTIDE ACETATE EQ 10MG BASE/VIAL INJECTABLE / INJECTION AB RLD 1998-11-25 N021008-002 SANDOSTATIN LAR OCTREOTIDE ACETATE EQ 20MG BASE/VIAL INJECTABLE / INJECTION AB RLD 1998-11-25 N021008-003 SANDOSTATIN LAR OCTREOTIDE ACETATE EQ 30MG BASE/VIAL INJECTABLE / INJECTION AB RLD, RS 1998-11-25
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 matching rows.
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.
Product history page 1 of 4 · 123 observed 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 N021008-001 SANDOSTATIN LAR EQ 10MG BASE/VIAL INJECTABLE / INJECTION AB RLD 1998-11-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021008-002 SANDOSTATIN LAR EQ 20MG BASE/VIAL INJECTABLE / INJECTION AB RLD 1998-11-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021008-003 SANDOSTATIN LAR EQ 30MG BASE/VIAL INJECTABLE / INJECTION AB RLD, RS 1998-11-25 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021008-001 SANDOSTATIN LAR EQ 10MG BASE/VIAL INJECTABLE / INJECTION AB RLD 1998-11-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021008-002 SANDOSTATIN LAR EQ 20MG BASE/VIAL INJECTABLE / INJECTION AB RLD 1998-11-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021008-003 SANDOSTATIN LAR EQ 30MG BASE/VIAL INJECTABLE / INJECTION AB RLD, RS 1998-11-25 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N021008-001 SANDOSTATIN LAR EQ 10MG BASE/VIAL INJECTABLE / INJECTION AB RLD 1998-11-25 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021008-002 SANDOSTATIN LAR EQ 20MG BASE/VIAL INJECTABLE / INJECTION AB RLD 1998-11-25 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021008-003 SANDOSTATIN LAR EQ 30MG BASE/VIAL INJECTABLE / INJECTION AB RLD, RS 1998-11-25 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021008-001 SANDOSTATIN LAR EQ 10MG BASE/VIAL INJECTABLE / INJECTION AB RLD 1998-11-25 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021008-002 SANDOSTATIN LAR EQ 20MG BASE/VIAL INJECTABLE / INJECTION AB RLD 1998-11-25 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021008-003 SANDOSTATIN LAR EQ 30MG BASE/VIAL INJECTABLE / INJECTION AB RLD, RS 1998-11-25 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021008-001 SANDOSTATIN LAR EQ 10MG BASE/VIAL INJECTABLE / INJECTION AB RLD 1998-11-25 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021008-002 SANDOSTATIN LAR EQ 20MG BASE/VIAL INJECTABLE / INJECTION AB RLD 1998-11-25 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021008-003 SANDOSTATIN LAR EQ 30MG BASE/VIAL INJECTABLE / INJECTION AB RLD, RS 1998-11-25 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021008-001 SANDOSTATIN LAR EQ 10MG BASE/VIAL INJECTABLE / INJECTION AB RLD 1998-11-25 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021008-002 SANDOSTATIN LAR EQ 20MG BASE/VIAL INJECTABLE / INJECTION AB RLD 1998-11-25 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021008-003 SANDOSTATIN LAR EQ 30MG BASE/VIAL INJECTABLE / INJECTION AB RLD, RS 1998-11-25 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021008-001 SANDOSTATIN LAR EQ 10MG BASE/VIAL INJECTABLE / INJECTION AB RLD 1998-11-25 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021008-002 SANDOSTATIN LAR EQ 20MG BASE/VIAL INJECTABLE / INJECTION AB RLD 1998-11-25 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021008-003 SANDOSTATIN LAR EQ 30MG BASE/VIAL INJECTABLE / INJECTION AB RLD, RS 1998-11-25 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021008-001 SANDOSTATIN LAR EQ 10MG BASE/VIAL INJECTABLE / INJECTION AB RLD 1998-11-25 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021008-002 SANDOSTATIN LAR EQ 20MG BASE/VIAL INJECTABLE / INJECTION AB RLD 1998-11-25 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021008-003 SANDOSTATIN LAR EQ 30MG BASE/VIAL INJECTABLE / INJECTION AB RLD, RS 1998-11-25 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021008-001 SANDOSTATIN LAR EQ 10MG BASE/VIAL INJECTABLE / INJECTION AB RLD 1998-11-25 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021008-002 SANDOSTATIN LAR EQ 20MG BASE/VIAL INJECTABLE / INJECTION AB RLD 1998-11-25 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021008-003 SANDOSTATIN LAR EQ 30MG BASE/VIAL INJECTABLE / INJECTION AB RLD, RS 1998-11-25 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N021008-001 SANDOSTATIN LAR EQ 10MG BASE/VIAL INJECTABLE / INJECTION AB RLD 1998-11-25 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N021008-002 SANDOSTATIN LAR EQ 20MG BASE/VIAL INJECTABLE / INJECTION AB RLD 1998-11-25 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N021008-003 SANDOSTATIN LAR EQ 30MG BASE/VIAL INJECTABLE / INJECTION AB RLD, RS 1998-11-25 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021008-001 SANDOSTATIN LAR EQ 10MG BASE/VIAL INJECTABLE / INJECTION AB RLD 1998-11-25 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021008-002 SANDOSTATIN LAR EQ 20MG BASE/VIAL INJECTABLE / INJECTION AB RLD 1998-11-25 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021008-003 SANDOSTATIN LAR EQ 30MG BASE/VIAL INJECTABLE / INJECTION AB RLD, RS 1998-11-25 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021008-001 SANDOSTATIN LAR EQ 10MG BASE/VIAL INJECTABLE / INJECTION AB RLD 1998-11-25 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021008-002 SANDOSTATIN LAR EQ 20MG BASE/VIAL INJECTABLE / INJECTION AB RLD 1998-11-25 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021008-003 SANDOSTATIN LAR EQ 30MG BASE/VIAL INJECTABLE / INJECTION AB RLD, RS 1998-11-25 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021008-001 SANDOSTATIN LAR EQ 10MG BASE/VIAL INJECTABLE / INJECTION AB RLD 1998-11-25 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021008-002 SANDOSTATIN LAR EQ 20MG BASE/VIAL INJECTABLE / INJECTION AB RLD 1998-11-25 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021008-003 SANDOSTATIN LAR EQ 30MG BASE/VIAL INJECTABLE / INJECTION AB RLD, RS 1998-11-25 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N021008-001 SANDOSTATIN LAR EQ 10MG BASE/VIAL INJECTABLE / INJECTION AB RLD 1998-11-25 8072bd15b7f6…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 54 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Sandostatin LAR Depot
Listing expiration 2026-12-31 Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 6 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 898589 Internal RxNorm lookup 898591 Internal RxNorm lookup 898601 Internal RxNorm lookup 898603 Internal RxNorm lookup 898605 Internal RxNorm lookup 898607 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 0078-0825-81 Sandostatin LAR Depot 1 in 1 KIT KIT 1 29
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0078-0825 SANDOSTATIN LAR DEPOT (OCTREOTIDE ACETATE) KIT [NOVARTIS PHARMACEUTICALS CORPORATION] 25 Current NDC, Legacy NDC, 1 package rows 20240723_d0b7fe9e-7000-4b79-ba3b-291ce92c14f9.zip
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 Marketing end Sample Exclude flag Status 0078-0825-81 00078082581 1 KIT in 1 KIT (0078-0825-81) * 2 mL in 1 SYRINGE * 6 mL in 1 VIAL (0078-0804-61) 1 kit 2016-07-22 0000-00-00 No No Current