Home NDC 0781-3164 Octreotide Acetate
Product NDC 0781-3164
11-digit product format 007813164
Labeler code 0781
Product ID 0781-3164_b02b276f-9007-4ec7-8bcd-40f14213d7f5
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Octreotide Acetate
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS; SUBCUTANEOUS
Labeler Sandoz Inc
Application NDA019667
Marketing category NDA
Marketing start 1988-10-21
Marketing end 0000-00-00
Substance OCTREOTIDE ACETATE
Active strength 1000 ug/mL
Pharmacologic classes Somatostatin Analog [EPC],Somatostatin Receptor Agonists [MoA]
NDC exclude flag E
Listing certified through 2018-12-31
Current FDA listing Historical FDA.report record 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 date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 0781-3164-75 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 0781-3164-75 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 0781-3164-75 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 0781-3164-75 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 0781-3164-75 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 0781-3164-75 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 0781-3164-75 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 0781-3164-75 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 0781-3164-75 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 0781-3164-75 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 0781-3164-75 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 0781-3164-75 557ba5c1ecfa…9c80585c8c6e…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 5 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N019667-001 SANDOSTATIN OCTREOTIDE ACETATE EQ 0.05MG BASE/ML INJECTABLE / INJECTION AP RLD, RS 1988-10-21 N019667-002 SANDOSTATIN OCTREOTIDE ACETATE EQ 0.1MG BASE/ML INJECTABLE / INJECTION AP RLD, RS 1988-10-21 N019667-003 SANDOSTATIN OCTREOTIDE ACETATE EQ 0.5MG BASE/ML INJECTABLE / INJECTION AP RLD, RS 1988-10-21 N019667-004 SANDOSTATIN OCTREOTIDE ACETATE EQ 0.2MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION RLD 1991-06-12 N019667-005 SANDOSTATIN OCTREOTIDE ACETATE EQ 1MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION RLD 1991-06-12
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 6 · 205 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 N019667-001 SANDOSTATIN EQ 0.05MG BASE/ML INJECTABLE / INJECTION AP RLD, RS 1988-10-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N019667-002 SANDOSTATIN EQ 0.1MG BASE/ML INJECTABLE / INJECTION AP RLD, RS 1988-10-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N019667-003 SANDOSTATIN EQ 0.5MG BASE/ML INJECTABLE / INJECTION AP RLD, RS 1988-10-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N019667-004 SANDOSTATIN EQ 0.2MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION RLD 1991-06-12 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N019667-005 SANDOSTATIN EQ 1MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION RLD 1991-06-12 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N019667-001 SANDOSTATIN EQ 0.05MG BASE/ML INJECTABLE / INJECTION AP RLD, RS 1988-10-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N019667-002 SANDOSTATIN EQ 0.1MG BASE/ML INJECTABLE / INJECTION AP RLD, RS 1988-10-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N019667-003 SANDOSTATIN EQ 0.5MG BASE/ML INJECTABLE / INJECTION AP RLD, RS 1988-10-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N019667-004 SANDOSTATIN EQ 0.2MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION RLD 1991-06-12 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N019667-005 SANDOSTATIN EQ 1MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION RLD 1991-06-12 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N019667-001 SANDOSTATIN EQ 0.05MG BASE/ML INJECTABLE / INJECTION AP RLD, RS 1988-10-21 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N019667-002 SANDOSTATIN EQ 0.1MG BASE/ML INJECTABLE / INJECTION AP RLD, RS 1988-10-21 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N019667-003 SANDOSTATIN EQ 0.5MG BASE/ML INJECTABLE / INJECTION AP RLD, RS 1988-10-21 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N019667-004 SANDOSTATIN EQ 0.2MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION RLD 1991-06-12 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N019667-005 SANDOSTATIN EQ 1MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION RLD 1991-06-12 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N019667-001 SANDOSTATIN EQ 0.05MG BASE/ML INJECTABLE / INJECTION AP RLD, RS 1988-10-21 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N019667-002 SANDOSTATIN EQ 0.1MG BASE/ML INJECTABLE / INJECTION AP RLD, RS 1988-10-21 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N019667-003 SANDOSTATIN EQ 0.5MG BASE/ML INJECTABLE / INJECTION AP RLD, RS 1988-10-21 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N019667-004 SANDOSTATIN EQ 0.2MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION RLD 1991-06-12 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N019667-005 SANDOSTATIN EQ 1MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION RLD 1991-06-12 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N019667-001 SANDOSTATIN EQ 0.05MG BASE/ML INJECTABLE / INJECTION AP RLD, RS 1988-10-21 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N019667-002 SANDOSTATIN EQ 0.1MG BASE/ML INJECTABLE / INJECTION AP RLD, RS 1988-10-21 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N019667-003 SANDOSTATIN EQ 0.5MG BASE/ML INJECTABLE / INJECTION AP RLD, RS 1988-10-21 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N019667-004 SANDOSTATIN EQ 0.2MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION RLD 1991-06-12 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N019667-005 SANDOSTATIN EQ 1MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION RLD 1991-06-12 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N019667-001 SANDOSTATIN EQ 0.05MG BASE/ML INJECTABLE / INJECTION AP RLD, RS 1988-10-21 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N019667-002 SANDOSTATIN EQ 0.1MG BASE/ML INJECTABLE / INJECTION AP RLD, RS 1988-10-21 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N019667-003 SANDOSTATIN EQ 0.5MG BASE/ML INJECTABLE / INJECTION AP RLD, RS 1988-10-21 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N019667-004 SANDOSTATIN EQ 0.2MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION RLD 1991-06-12 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N019667-005 SANDOSTATIN EQ 1MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION RLD 1991-06-12 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N019667-001 SANDOSTATIN EQ 0.05MG BASE/ML INJECTABLE / INJECTION AP RLD, RS 1988-10-21 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N019667-002 SANDOSTATIN EQ 0.1MG BASE/ML INJECTABLE / INJECTION AP RLD, RS 1988-10-21 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N019667-003 SANDOSTATIN EQ 0.5MG BASE/ML INJECTABLE / INJECTION AP RLD, RS 1988-10-21 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N019667-004 SANDOSTATIN EQ 0.2MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION RLD 1991-06-12 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N019667-005 SANDOSTATIN EQ 1MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION RLD 1991-06-12 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N019667-001 SANDOSTATIN EQ 0.05MG BASE/ML INJECTABLE / INJECTION AP RLD, RS 1988-10-21 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N019667-002 SANDOSTATIN EQ 0.1MG BASE/ML INJECTABLE / INJECTION AP RLD, RS 1988-10-21 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N019667-003 SANDOSTATIN EQ 0.5MG BASE/ML INJECTABLE / INJECTION AP RLD, RS 1988-10-21 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N019667-004 SANDOSTATIN EQ 0.2MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION RLD 1991-06-12 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N019667-005 SANDOSTATIN EQ 1MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION RLD 1991-06-12 5bbf6a4d5a75…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 131 observed states.
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 Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Sandostatin OCTREOTIDE ACETATE Novartis Pharmaceuticals Corporation 4e2c9856-1836-49f0-9472-4dbeeb408f39 2026-07-22 Warnings, Adverse reactions Exact identifier application applno (NDA): 019667 application number: NDA019667