Home NDC 68083-517 Octreotide Acetate
Product NDC 68083-517
11-digit product format 680830517
Labeler code 68083
Product ID 68083-517_723308d0-ea28-4f3f-b993-0bc5cfe33cfe
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Octreotide Acetate
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS; SUBCUTANEOUS
Labeler Gland Pharma Limited
Application ANDA216839
Marketing category ANDA
Marketing start 2023-06-22
Substance OCTREOTIDE ACETATE
Active strength 100 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 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A216839-001 OCTREOTIDE ACETATE OCTREOTIDE ACETATE EQ 0.5MG BASE/ML INJECTABLE / INJECTION AP 2023-06-22 A216839-002 OCTREOTIDE ACETATE OCTREOTIDE ACETATE EQ 0.1MG BASE/ML INJECTABLE / INJECTION AP 2023-06-22
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 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 2 · 42 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 A216839-001 OCTREOTIDE ACETATE EQ 0.5MG BASE/ML INJECTABLE / INJECTION AP 2023-06-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A216839-002 OCTREOTIDE ACETATE EQ 0.1MG BASE/ML INJECTABLE / INJECTION AP 2023-06-22 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A216839-001 OCTREOTIDE ACETATE EQ 0.5MG BASE/ML INJECTABLE / INJECTION AP 2023-06-22 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A216839-002 OCTREOTIDE ACETATE EQ 0.1MG BASE/ML INJECTABLE / INJECTION AP 2023-06-22 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A216839-001 OCTREOTIDE ACETATE EQ 0.5MG BASE/ML INJECTABLE / INJECTION AP 2023-06-22 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A216839-002 OCTREOTIDE ACETATE EQ 0.1MG BASE/ML INJECTABLE / INJECTION AP 2023-06-22 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A216839-001 OCTREOTIDE ACETATE EQ 0.5MG BASE/ML INJECTABLE / INJECTION AP 2023-06-22 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A216839-002 OCTREOTIDE ACETATE EQ 0.1MG BASE/ML INJECTABLE / INJECTION AP 2023-06-22 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A216839-001 OCTREOTIDE ACETATE EQ 0.5MG BASE/ML INJECTABLE / INJECTION AP 2023-06-22 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A216839-002 OCTREOTIDE ACETATE EQ 0.1MG BASE/ML INJECTABLE / INJECTION AP 2023-06-22 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A216839-001 OCTREOTIDE ACETATE EQ 0.5MG BASE/ML INJECTABLE / INJECTION AP 2023-06-22 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A216839-002 OCTREOTIDE ACETATE EQ 0.1MG BASE/ML INJECTABLE / INJECTION AP 2023-06-22 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A216839-001 OCTREOTIDE ACETATE EQ 0.5MG BASE/ML INJECTABLE / INJECTION AP 2023-06-22 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A216839-002 OCTREOTIDE ACETATE EQ 0.1MG BASE/ML INJECTABLE / INJECTION AP 2023-06-22 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A216839-001 OCTREOTIDE ACETATE EQ 0.5MG BASE/ML INJECTABLE / INJECTION AP 2023-06-22 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A216839-002 OCTREOTIDE ACETATE EQ 0.1MG BASE/ML INJECTABLE / INJECTION AP 2023-06-22 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A216839-001 OCTREOTIDE ACETATE EQ 0.5MG BASE/ML INJECTABLE / INJECTION AP 2023-06-22 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A216839-002 OCTREOTIDE ACETATE EQ 0.1MG BASE/ML INJECTABLE / INJECTION AP 2023-06-22 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A216839-001 OCTREOTIDE ACETATE EQ 0.5MG BASE/ML INJECTABLE / INJECTION AP 2023-06-22 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A216839-002 OCTREOTIDE ACETATE EQ 0.1MG BASE/ML INJECTABLE / INJECTION AP 2023-06-22 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A216839-001 OCTREOTIDE ACETATE EQ 0.5MG BASE/ML INJECTABLE / INJECTION AP 2023-06-22 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A216839-002 OCTREOTIDE ACETATE EQ 0.1MG BASE/ML INJECTABLE / INJECTION AP 2023-06-22 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A216839-001 OCTREOTIDE ACETATE EQ 0.5MG BASE/ML INJECTABLE / INJECTION AP 2023-06-22 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A216839-002 OCTREOTIDE ACETATE EQ 0.1MG BASE/ML INJECTABLE / INJECTION AP 2023-06-22 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A216839-001 OCTREOTIDE ACETATE EQ 0.5MG BASE/ML INJECTABLE / INJECTION AP 2023-06-22 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A216839-002 OCTREOTIDE ACETATE EQ 0.1MG BASE/ML INJECTABLE / INJECTION AP 2023-06-22 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A216839-001 OCTREOTIDE ACETATE EQ 0.5MG BASE/ML INJECTABLE / INJECTION AP 2023-06-22 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A216839-002 OCTREOTIDE ACETATE EQ 0.1MG BASE/ML INJECTABLE / INJECTION AP 2023-06-22 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A216839-001 OCTREOTIDE ACETATE EQ 0.5MG BASE/ML INJECTABLE / INJECTION AP 2023-06-22 6a51e52b5d6a…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A216839-002 OCTREOTIDE ACETATE EQ 0.1MG BASE/ML INJECTABLE / INJECTION AP 2023-06-22 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A216839-001 OCTREOTIDE ACETATE EQ 0.5MG BASE/ML INJECTABLE / INJECTION AP 2023-06-22 1c564ffb4f44…2024-02-18 07:12 UTC 2024-02 A216839-002 OCTREOTIDE ACETATE EQ 0.1MG BASE/ML INJECTABLE / INJECTION AP 2023-06-22 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A216839-001 OCTREOTIDE ACETATE EQ 0.5MG BASE/ML INJECTABLE / INJECTION AP 2023-06-22 ea1830bbd6c7…2023-12-20 04:57 UTC 2023-12 A216839-002 OCTREOTIDE ACETATE EQ 0.1MG BASE/ML INJECTABLE / INJECTION AP 2023-06-22 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A216839-001 OCTREOTIDE ACETATE EQ 0.5MG BASE/ML INJECTABLE / INJECTION AP 2023-06-22 a72a2bbeb626…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A216839-002 OCTREOTIDE ACETATE EQ 0.1MG BASE/ML INJECTABLE / INJECTION AP 2023-06-22 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A216839-001 OCTREOTIDE ACETATE EQ 0.5MG BASE/ML INJECTABLE / INJECTION AP 2023-06-22 9b2671bbb829…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A216839-002 OCTREOTIDE ACETATE EQ 0.1MG BASE/ML INJECTABLE / INJECTION AP 2023-06-22 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A216839-001 OCTREOTIDE ACETATE EQ 0.5MG BASE/ML INJECTABLE / INJECTION AP 2023-06-22 a67488948f0b…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A216839-002 OCTREOTIDE ACETATE EQ 0.1MG BASE/ML INJECTABLE / INJECTION AP 2023-06-22 a67488948f0b…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Octreotide Acetate
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength OCTREOTIDE ACETATE 100 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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 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 68083-517-10 Octreotide Acetate 1 mL in 1 VIAL INJECTION, SOLUTION 1 7 68083-517-10 Octreotide Acetate 10 in 1 CARTON INJECTION, SOLUTION 10 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68083-517 OCTREOTIDE ACETATE INJECTION, SOLUTION [GLAND PHARMA LIMITED] 7 Current NDC, 2 package rows 20240805_884e4287-a4d8-4a6e-8d99-dbe5e88875b9.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 · 2 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 68083-517-10 68083051710 10 VIAL in 1 CARTON (68083-517-10) / 1 mL in 1 VIAL 10 vial 2023-06-22 No No Current