Home NDC 0078-0180 Sandostatin
Product NDC 0078-0180
11-digit product format 000780180
Labeler code 0078
Product ID 0078-0180_ad42b59d-8ad5-4855-96a9-f40c7ef4a7e3
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name octreotide acetate
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS; SUBCUTANEOUS
Labeler Novartis Pharmaceuticals Corporation
Application NDA019667
Marketing category NDA
Marketing start 1988-10-21
Substance OCTREOTIDE ACETATE
Active strength 50 ug/mL
Pharmacologic classes Somatostatin Analog [EPC], Somatostatin Receptor Agonists [MoA]
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 · 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SANDOSTATIN OCTREOTIDE ACETATE EQ 0.2MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION RLD 1991-06-12 N019667-005 SANDOSTATIN OCTREOTIDE ACETATE EQ 1MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION RLD 1991-06-12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.
Additional Listing Data#
Finished product Yes
Brand name base Sandostatin
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength OCTREOTIDE ACETATE 50 ug/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 75R0U2568I Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 6 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 207194 Internal RxNorm lookup 207198 Internal RxNorm lookup 207200 Internal RxNorm lookup 312068 Internal RxNorm lookup 312069 Internal RxNorm lookup 312070 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 0078-0180-01 Sandostatin 10 in 1 PACKAGE INJECTION, SOLUTION 10 22 0078-0180-61 Sandostatin 1 mL in 1 AMPULE INJECTION, SOLUTION 1 22
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0078-0180 SANDOSTATIN (OCTREOTIDE ACETATE) INJECTION, SOLUTION [NOVARTIS PHARMACEUTICALS CORPORATION] 21 Current NDC, Legacy NDC, 2 package rows 20250122_4e2c9856-1836-49f0-9472-4dbeeb408f39.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 0078-0180-01 00078018001 10 AMPULE in 1 PACKAGE (0078-0180-01) / 1 mL in 1 AMPULE (0078-0180-61) 10 ampule 1988-10-21 0000-00-00 No No Current 0078-0180-61 00078018061 1 mL in 1 AMPULE 1 ml Historical