Home NDC 0703-3301-04 Octreotide Acetate
Product NDC 0703-3301
Requested package NDC 0703-3301-04
11-digit product format 007033301
Labeler code 0703
Product ID 0703-3301_2f5b5421-18fe-47d0-8807-b1478eb82b37
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Octreotide Acetate
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS; SUBCUTANEOUS
Labeler Teva Parenteral Medicines, Inc.
Application ANDA075957
Marketing category ANDA
Marketing start 2005-11-14
Marketing end 0000-00-00
Substance OCTREOTIDE ACETATE
Active strength 50 ug/mL
Pharmacologic classes Somatostatin Analog [EPC],Somatostatin Receptor Agonists [MoA]
NDC exclude flag No
Listing certified through 2022-12-31
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 · 12 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…
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 Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded OCTREOTIDE ACETATE ACTIVE INGREDIENT 75R0U2568I OCTREOTIDE ACETATE INJECTION, SOLUTION [TEVA PARENTERAL MEDICINES, INC.] 3 OCTREOTIDE ACTIVE MOIETY RWM8CCW8GP OCTREOTIDE ACETATE INJECTION, SOLUTION [TEVA PARENTERAL MEDICINES, INC.] 3 ACETIC ACID INACTIVE INGREDIENT Q40Q9N063P OCTREOTIDE ACETATE INJECTION, SOLUTION [TEVA PARENTERAL MEDICINES, INC.] 3 MANNITOL INACTIVE INGREDIENT 3OWL53L36A OCTREOTIDE ACETATE INJECTION, SOLUTION [TEVA PARENTERAL MEDICINES, INC.] 3 PHENOL INACTIVE INGREDIENT 339NCG44TV OCTREOTIDE ACETATE INJECTION, SOLUTION [TEVA PARENTERAL MEDICINES, INC.] 3 SODIUM ACETATE INACTIVE INGREDIENT 4550K0SC9B OCTREOTIDE ACETATE INJECTION, SOLUTION [TEVA PARENTERAL MEDICINES, INC.] 3 WATER INACTIVE INGREDIENT 059QF0KO0R OCTREOTIDE ACETATE INJECTION, SOLUTION [TEVA PARENTERAL MEDICINES, INC.] 3
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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 0703-3301-04 00703330104 25 VIAL, SINGLE-USE in 1 TRAY (0703-3301-04) > 1 mL in 1 VIAL, SINGLE-USE (0703-3301-01) 2005-11-14 0000-00-00 No No Current