Sandostatin LAR Depot

Product NDC
0078-0647
11-digit product format
000780647
Labeler code
0078
Product ID
0078-0647_09c39d97-0b90-4a50-b3f7-ba58cc175186
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
octreotide acetate
Dosage form
KIT
Labeler
Novartis Pharmaceuticals Corporation
Application
NDA021008
Marketing category
NDA
Marketing start
2015-02-01
Marketing end
2019-06-30
Active strength
0
NDC exclude flag
No
Listing certified through
0000-00-00
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct0078-0647DDiscontinued by firm2026-08-03
excluded packagepackage0078-06470078-0647-81DDiscontinued by firm2026-08-03

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 24 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0078-0647-81d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0078-0647-81f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0078-0647-812ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0078-0647-81a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0078-0647-81cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0078-0647-81cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0078-0647-81302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0078-0647-81ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0078-0647-810efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0078-0647-81ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0078-0647-81367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0078-0647-81557ba5c1ecfa…9c80585c8c6e…

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N021008-001SANDOSTATIN LAROCTREOTIDE ACETATEEQ 10MG BASE/VIALINJECTABLE / INJECTIONABRLD1998-11-25
N021008-002SANDOSTATIN LAROCTREOTIDE ACETATEEQ 20MG BASE/VIALINJECTABLE / INJECTIONABRLD1998-11-25
N021008-003SANDOSTATIN LAROCTREOTIDE ACETATEEQ 30MG BASE/VIALINJECTABLE / INJECTIONABRLD, RS1998-11-25

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
N021008-001AB
N021008-002AB
N021008-003AB

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N021008-001SANDOSTATIN LAREQ 10MG BASE/VIALINJECTABLE / INJECTIONABRLD1998-11-25011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021008-002SANDOSTATIN LAREQ 20MG BASE/VIALINJECTABLE / INJECTIONABRLD1998-11-25011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021008-003SANDOSTATIN LAREQ 30MG BASE/VIALINJECTABLE / INJECTIONABRLD, RS1998-11-25011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021008-001SANDOSTATIN LAREQ 10MG BASE/VIALINJECTABLE / INJECTIONABRLD1998-11-2531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021008-002SANDOSTATIN LAREQ 20MG BASE/VIALINJECTABLE / INJECTIONABRLD1998-11-2531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021008-003SANDOSTATIN LAREQ 30MG BASE/VIALINJECTABLE / INJECTIONABRLD, RS1998-11-2531067a03dcf5…
2025-08-23 18:47 UTC2025-08N021008-001SANDOSTATIN LAREQ 10MG BASE/VIALINJECTABLE / INJECTIONABRLD1998-11-256a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021008-002SANDOSTATIN LAREQ 20MG BASE/VIALINJECTABLE / INJECTIONABRLD1998-11-256a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021008-003SANDOSTATIN LAREQ 30MG BASE/VIALINJECTABLE / INJECTIONABRLD, RS1998-11-256a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021008-001SANDOSTATIN LAREQ 10MG BASE/VIALINJECTABLE / INJECTIONABRLD1998-11-25fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021008-002SANDOSTATIN LAREQ 20MG BASE/VIALINJECTABLE / INJECTIONABRLD1998-11-25fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021008-003SANDOSTATIN LAREQ 30MG BASE/VIALINJECTABLE / INJECTIONABRLD, RS1998-11-25fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021008-001SANDOSTATIN LAREQ 10MG BASE/VIALINJECTABLE / INJECTIONABRLD1998-11-25b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021008-002SANDOSTATIN LAREQ 20MG BASE/VIALINJECTABLE / INJECTIONABRLD1998-11-25b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021008-003SANDOSTATIN LAREQ 30MG BASE/VIALINJECTABLE / INJECTIONABRLD, RS1998-11-25b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021008-001SANDOSTATIN LAREQ 10MG BASE/VIALINJECTABLE / INJECTIONABRLD1998-11-2503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021008-002SANDOSTATIN LAREQ 20MG BASE/VIALINJECTABLE / INJECTIONABRLD1998-11-2503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021008-003SANDOSTATIN LAREQ 30MG BASE/VIALINJECTABLE / INJECTIONABRLD, RS1998-11-2503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021008-001SANDOSTATIN LAREQ 10MG BASE/VIALINJECTABLE / INJECTIONABRLD1998-11-252680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021008-002SANDOSTATIN LAREQ 20MG BASE/VIALINJECTABLE / INJECTIONABRLD1998-11-252680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021008-003SANDOSTATIN LAREQ 30MG BASE/VIALINJECTABLE / INJECTIONABRLD, RS1998-11-252680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021008-001SANDOSTATIN LAREQ 10MG BASE/VIALINJECTABLE / INJECTIONABRLD1998-11-255bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021008-002SANDOSTATIN LAREQ 20MG BASE/VIALINJECTABLE / INJECTIONABRLD1998-11-255bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021008-003SANDOSTATIN LAREQ 30MG BASE/VIALINJECTABLE / INJECTIONABRLD, RS1998-11-255bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021008-001SANDOSTATIN LAREQ 10MG BASE/VIALINJECTABLE / INJECTIONABRLD1998-11-25d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021008-002SANDOSTATIN LAREQ 20MG BASE/VIALINJECTABLE / INJECTIONABRLD1998-11-25d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021008-003SANDOSTATIN LAREQ 30MG BASE/VIALINJECTABLE / INJECTIONABRLD, RS1998-11-25d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N021008-001SANDOSTATIN LAREQ 10MG BASE/VIALINJECTABLE / INJECTIONABRLD1998-11-25d06236e962d9…
2024-10-29 15:01 UTC2024-10N021008-002SANDOSTATIN LAREQ 20MG BASE/VIALINJECTABLE / INJECTIONABRLD1998-11-25d06236e962d9…
2024-10-29 15:01 UTC2024-10N021008-003SANDOSTATIN LAREQ 30MG BASE/VIALINJECTABLE / INJECTIONABRLD, RS1998-11-25d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021008-001SANDOSTATIN LAREQ 10MG BASE/VIALINJECTABLE / INJECTIONABRLD1998-11-2579d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021008-002SANDOSTATIN LAREQ 20MG BASE/VIALINJECTABLE / INJECTIONABRLD1998-11-2579d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021008-003SANDOSTATIN LAREQ 30MG BASE/VIALINJECTABLE / INJECTIONABRLD, RS1998-11-2579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021008-001SANDOSTATIN LAREQ 10MG BASE/VIALINJECTABLE / INJECTIONABRLD1998-11-25301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021008-002SANDOSTATIN LAREQ 20MG BASE/VIALINJECTABLE / INJECTIONABRLD1998-11-25301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021008-003SANDOSTATIN LAREQ 30MG BASE/VIALINJECTABLE / INJECTIONABRLD, RS1998-11-25301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021008-001SANDOSTATIN LAREQ 10MG BASE/VIALINJECTABLE / INJECTIONABRLD1998-11-251e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021008-002SANDOSTATIN LAREQ 20MG BASE/VIALINJECTABLE / INJECTIONABRLD1998-11-251e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021008-003SANDOSTATIN LAREQ 30MG BASE/VIALINJECTABLE / INJECTIONABRLD, RS1998-11-251e350fbaab3a…
2024-05-31 18:47 UTC2024-05N021008-001SANDOSTATIN LAREQ 10MG BASE/VIALINJECTABLE / INJECTIONABRLD1998-11-258072bd15b7f6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 54 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02N021008-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021008-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021008-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021008-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021008-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021008-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08N021008-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021008-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021008-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021008-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021008-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021008-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021008-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021008-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021008-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021008-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021008-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021008-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021008-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021008-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021008-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021008-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021008-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021008-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021008-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021008-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021008-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N021008-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10N021008-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10N021008-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021008-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021008-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021008-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021008-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021008-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021008-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021008-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021008-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021008-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05N021008-001AB18072bd15b7f6…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0078-0647-61EA - Each0078-0647aaa36793-32b0-47d7-854a-85d5a0f3a08612015-05-05
0078-0647-81EA - Each0078-0647f50106cb-e017-46d7-92fc-83145563c00612015-05-05

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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sandostatin LAR DepotOCTREOTIDE ACETATENovartis Pharmaceuticals Corporationd0b7fe9e-7000-4b79-ba3b-291ce92c14f92025-12-22Warnings, Adverse reactionsExact identifier
application applno (NDA): 021008
application number: NDA021008