Home NDC 63629-8831 Octreotide Acetate
Product NDC 63629-8831
11-digit product format 636298831
Labeler code 63629
Product ID 63629-8831_5c964434-57fe-4491-8153-969aae896174
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Octreotide Acetate
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS; SUBCUTANEOUS
Labeler Bryant Ranch Prepack
Application ANDA075957
Marketing category ANDA
Marketing start 2005-11-14
Marketing end 0000-00-00
Substance OCTREOTIDE ACETATE
Active strength 100 ug/mL
Pharmacologic classes Somatostatin Analog [EPC], Somatostatin Receptor Agonists [MoA]
NDC exclude flag No
Listing certified through 2023-12-31
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 · 30 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 63629-8831-1 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 63629-8831-1 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 63629-8831-1 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 63629-8831-1 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 63629-8831-1 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 63629-8831-1 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 63629-8831-1 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 63629-8831-1 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 63629-8831-1 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 63629-8831-1 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 63629-8831-1 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 63629-8831-1 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 excluded product product 8af77b9d5b6f…d9bbb34c5368…2024-05-28 21:12 UTC · source 2024-05-28 excluded package package 63629-8831-1 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 excluded product product 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 63629-8831-1 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 excluded product product 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 63629-8831-1 1332a3947898…d4bfe170f9cd…
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 A075957-001 OCTREOTIDE ACETATE OCTREOTIDE ACETATE EQ 0.05MG BASE/ML INJECTABLE / INJECTION AP 2005-10-03 A075957-002 OCTREOTIDE ACETATE OCTREOTIDE ACETATE EQ 0.1MG BASE/ML INJECTABLE / INJECTION AP 2005-10-03 A075957-003 OCTREOTIDE ACETATE OCTREOTIDE ACETATE EQ 0.5MG BASE/ML INJECTABLE / INJECTION AP 2005-10-03
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 A075957-001 OCTREOTIDE ACETATE EQ 0.05MG BASE/ML INJECTABLE / INJECTION AP 2005-10-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A075957-002 OCTREOTIDE ACETATE EQ 0.1MG BASE/ML INJECTABLE / INJECTION AP 2005-10-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A075957-003 OCTREOTIDE ACETATE EQ 0.5MG BASE/ML INJECTABLE / INJECTION AP 2005-10-03 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075957-001 OCTREOTIDE ACETATE EQ 0.05MG BASE/ML INJECTABLE / INJECTION AP 2005-10-03 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075957-002 OCTREOTIDE ACETATE EQ 0.1MG BASE/ML INJECTABLE / INJECTION AP 2005-10-03 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075957-003 OCTREOTIDE ACETATE EQ 0.5MG BASE/ML INJECTABLE / INJECTION AP 2005-10-03 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A075957-001 OCTREOTIDE ACETATE EQ 0.05MG BASE/ML INJECTABLE / INJECTION AP 2005-10-03 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A075957-002 OCTREOTIDE ACETATE EQ 0.1MG BASE/ML INJECTABLE / INJECTION AP 2005-10-03 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A075957-003 OCTREOTIDE ACETATE EQ 0.5MG BASE/ML INJECTABLE / INJECTION AP 2005-10-03 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075957-001 OCTREOTIDE ACETATE EQ 0.05MG BASE/ML INJECTABLE / INJECTION AP 2005-10-03 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075957-002 OCTREOTIDE ACETATE EQ 0.1MG BASE/ML INJECTABLE / INJECTION AP 2005-10-03 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075957-003 OCTREOTIDE ACETATE EQ 0.5MG BASE/ML INJECTABLE / INJECTION AP 2005-10-03 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075957-001 OCTREOTIDE ACETATE EQ 0.05MG BASE/ML INJECTABLE / INJECTION AP 2005-10-03 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075957-002 OCTREOTIDE ACETATE EQ 0.1MG BASE/ML INJECTABLE / INJECTION AP 2005-10-03 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075957-003 OCTREOTIDE ACETATE EQ 0.5MG BASE/ML INJECTABLE / INJECTION AP 2005-10-03 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075957-001 OCTREOTIDE ACETATE EQ 0.05MG BASE/ML INJECTABLE / INJECTION AP 2005-10-03 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075957-002 OCTREOTIDE ACETATE EQ 0.1MG BASE/ML INJECTABLE / INJECTION AP 2005-10-03 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075957-003 OCTREOTIDE ACETATE EQ 0.5MG BASE/ML INJECTABLE / INJECTION AP 2005-10-03 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075957-001 OCTREOTIDE ACETATE EQ 0.05MG BASE/ML INJECTABLE / INJECTION AP 2005-10-03 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075957-002 OCTREOTIDE ACETATE EQ 0.1MG BASE/ML INJECTABLE / INJECTION AP 2005-10-03 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075957-003 OCTREOTIDE ACETATE EQ 0.5MG BASE/ML INJECTABLE / INJECTION AP 2005-10-03 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075957-001 OCTREOTIDE ACETATE EQ 0.05MG BASE/ML INJECTABLE / INJECTION AP 2005-10-03 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075957-002 OCTREOTIDE ACETATE EQ 0.1MG BASE/ML INJECTABLE / INJECTION AP 2005-10-03 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075957-003 OCTREOTIDE ACETATE EQ 0.5MG BASE/ML INJECTABLE / INJECTION AP 2005-10-03 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075957-001 OCTREOTIDE ACETATE EQ 0.05MG BASE/ML INJECTABLE / INJECTION AP 2005-10-03 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075957-002 OCTREOTIDE ACETATE EQ 0.1MG BASE/ML INJECTABLE / INJECTION AP 2005-10-03 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075957-003 OCTREOTIDE ACETATE EQ 0.5MG BASE/ML INJECTABLE / INJECTION AP 2005-10-03 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A075957-001 OCTREOTIDE ACETATE EQ 0.05MG BASE/ML INJECTABLE / INJECTION AP 2005-10-03 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A075957-002 OCTREOTIDE ACETATE EQ 0.1MG BASE/ML INJECTABLE / INJECTION AP 2005-10-03 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A075957-003 OCTREOTIDE ACETATE EQ 0.5MG BASE/ML INJECTABLE / INJECTION AP 2005-10-03 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A075957-001 OCTREOTIDE ACETATE EQ 0.05MG BASE/ML INJECTABLE / INJECTION AP 2005-10-03 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A075957-002 OCTREOTIDE ACETATE EQ 0.1MG BASE/ML INJECTABLE / INJECTION AP 2005-10-03 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A075957-003 OCTREOTIDE ACETATE EQ 0.5MG BASE/ML INJECTABLE / INJECTION AP 2005-10-03 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A075957-001 OCTREOTIDE ACETATE EQ 0.05MG BASE/ML INJECTABLE / INJECTION AP 2005-10-03 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A075957-002 OCTREOTIDE ACETATE EQ 0.1MG BASE/ML INJECTABLE / INJECTION AP 2005-10-03 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A075957-003 OCTREOTIDE ACETATE EQ 0.5MG BASE/ML INJECTABLE / INJECTION AP 2005-10-03 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A075957-001 OCTREOTIDE ACETATE EQ 0.05MG BASE/ML INJECTABLE / INJECTION AP 2005-10-03 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A075957-002 OCTREOTIDE ACETATE EQ 0.1MG BASE/ML INJECTABLE / INJECTION AP 2005-10-03 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A075957-003 OCTREOTIDE ACETATE EQ 0.5MG BASE/ML INJECTABLE / INJECTION AP 2005-10-03 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A075957-001 OCTREOTIDE ACETATE EQ 0.05MG BASE/ML INJECTABLE / INJECTION AP 2005-10-03 8072bd15b7f6…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 123 observed states.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 63629-8831-1 Octreotide Acetate 1 mL in 1 VIAL, SINGLE-USE INJECTION, SOLUTION 1 101 63629-8831-1 Octreotide Acetate 25 in 1 TRAY INJECTION, SOLUTION 25 101
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63629-8831 OCTREOTIDE ACETATE INJECTION, SOLUTION [BRYANT RANCH PREPACK] 101 Legacy NDC, 2 package rows 20220428_dc66e7f9-5879-49b6-b093-e31fd2afbe8c.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 Marketing start Marketing end Sample Exclude flag Status 63629-8831-1 63629883101 25 VIAL, SINGLE-USE in 1 TRAY (63629-8831-1) > 1 mL in 1 VIAL, SINGLE-USE 2021-09-10 0000-00-00 No No Current