Home NDC 63629-8831-1 Octreotide Acetate
Product NDC 63629-8831
Requested package NDC 63629-8831-1
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 · 15 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 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