Home NDC 0641-6177 Octreotide Acetate
Product NDC 0641-6177
11-digit product format 006416177
Labeler code 0641
Product ID 0641-6177_efa5d8e8-57ab-4b56-b8d7-f856ea97404c
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Octreotide Acetate
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS; SUBCUTANEOUS
Labeler Hikma Pharmaceuticals USA Inc.
Application ANDA076330
Marketing category ANDA
Marketing start 2005-04-08
Substance OCTREOTIDE ACETATE
Active strength 200 ug/mL
Pharmacologic classes Somatostatin Analog [EPC], Somatostatin Receptor Agonists [MoA]
NDC exclude flag No
Listing certified through 2027-12-31
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 A076330-001 OCTREOTIDE ACETATE OCTREOTIDE ACETATE EQ 0.2MG BASE/ML INJECTABLE / INJECTION AP RS 2005-04-08 A076330-002 OCTREOTIDE ACETATE OCTREOTIDE ACETATE EQ 1MG BASE/ML INJECTABLE / INJECTION AP RS 2005-04-08
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 3 · 82 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 A076330-001 OCTREOTIDE ACETATE EQ 0.2MG BASE/ML INJECTABLE / INJECTION AP RS 2005-04-08 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A076330-002 OCTREOTIDE ACETATE EQ 1MG BASE/ML INJECTABLE / INJECTION AP RS 2005-04-08 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076330-001 OCTREOTIDE ACETATE EQ 0.2MG BASE/ML INJECTABLE / INJECTION AP RS 2005-04-08 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076330-002 OCTREOTIDE ACETATE EQ 1MG BASE/ML INJECTABLE / INJECTION AP RS 2005-04-08 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A076330-001 OCTREOTIDE ACETATE EQ 0.2MG BASE/ML INJECTABLE / INJECTION AP RS 2005-04-08 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A076330-002 OCTREOTIDE ACETATE EQ 1MG BASE/ML INJECTABLE / INJECTION AP RS 2005-04-08 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076330-001 OCTREOTIDE ACETATE EQ 0.2MG BASE/ML INJECTABLE / INJECTION AP RS 2005-04-08 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076330-002 OCTREOTIDE ACETATE EQ 1MG BASE/ML INJECTABLE / INJECTION AP RS 2005-04-08 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076330-001 OCTREOTIDE ACETATE EQ 0.2MG BASE/ML INJECTABLE / INJECTION AP RS 2005-04-08 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076330-002 OCTREOTIDE ACETATE EQ 1MG BASE/ML INJECTABLE / INJECTION AP RS 2005-04-08 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076330-001 OCTREOTIDE ACETATE EQ 0.2MG BASE/ML INJECTABLE / INJECTION AP RS 2005-04-08 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076330-002 OCTREOTIDE ACETATE EQ 1MG BASE/ML INJECTABLE / INJECTION AP RS 2005-04-08 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076330-001 OCTREOTIDE ACETATE EQ 0.2MG BASE/ML INJECTABLE / INJECTION AP RS 2005-04-08 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076330-002 OCTREOTIDE ACETATE EQ 1MG BASE/ML INJECTABLE / INJECTION AP RS 2005-04-08 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076330-001 OCTREOTIDE ACETATE EQ 0.2MG BASE/ML INJECTABLE / INJECTION AP RS 2005-04-08 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076330-002 OCTREOTIDE ACETATE EQ 1MG BASE/ML INJECTABLE / INJECTION AP RS 2005-04-08 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076330-001 OCTREOTIDE ACETATE EQ 0.2MG BASE/ML INJECTABLE / INJECTION AP RS 2005-04-08 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076330-002 OCTREOTIDE ACETATE EQ 1MG BASE/ML INJECTABLE / INJECTION AP RS 2005-04-08 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A076330-001 OCTREOTIDE ACETATE EQ 0.2MG BASE/ML INJECTABLE / INJECTION AP RS 2005-04-08 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A076330-002 OCTREOTIDE ACETATE EQ 1MG BASE/ML INJECTABLE / INJECTION AP RS 2005-04-08 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A076330-001 OCTREOTIDE ACETATE EQ 0.2MG BASE/ML INJECTABLE / INJECTION AP RS 2005-04-08 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A076330-002 OCTREOTIDE ACETATE EQ 1MG BASE/ML INJECTABLE / INJECTION AP RS 2005-04-08 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A076330-001 OCTREOTIDE ACETATE EQ 0.2MG BASE/ML INJECTABLE / INJECTION AP RS 2005-04-08 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A076330-002 OCTREOTIDE ACETATE EQ 1MG BASE/ML INJECTABLE / INJECTION AP RS 2005-04-08 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A076330-001 OCTREOTIDE ACETATE EQ 0.2MG BASE/ML INJECTABLE / INJECTION AP RS 2005-04-08 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A076330-002 OCTREOTIDE ACETATE EQ 1MG BASE/ML INJECTABLE / INJECTION AP RS 2005-04-08 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A076330-001 OCTREOTIDE ACETATE EQ 0.2MG BASE/ML INJECTABLE / INJECTION AP RS 2005-04-08 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A076330-002 OCTREOTIDE ACETATE EQ 1MG BASE/ML INJECTABLE / INJECTION AP RS 2005-04-08 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A076330-001 OCTREOTIDE ACETATE EQ 0.2MG BASE/ML INJECTABLE / INJECTION AP RS 2005-04-08 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A076330-002 OCTREOTIDE ACETATE EQ 1MG BASE/ML INJECTABLE / INJECTION AP RS 2005-04-08 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A076330-001 OCTREOTIDE ACETATE EQ 0.2MG BASE/ML INJECTABLE / INJECTION AP RS 2005-04-08 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A076330-002 OCTREOTIDE ACETATE EQ 1MG BASE/ML INJECTABLE / INJECTION AP RS 2005-04-08 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A076330-001 OCTREOTIDE ACETATE EQ 0.2MG BASE/ML INJECTABLE / INJECTION AP RS 2005-04-08 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A076330-002 OCTREOTIDE ACETATE EQ 1MG BASE/ML INJECTABLE / INJECTION AP RS 2005-04-08 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A076330-001 OCTREOTIDE ACETATE EQ 0.2MG BASE/ML INJECTABLE / INJECTION AP RS 2005-04-08 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A076330-002 OCTREOTIDE ACETATE EQ 1MG BASE/ML INJECTABLE / INJECTION AP RS 2005-04-08 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A076330-001 OCTREOTIDE ACETATE EQ 0.2MG BASE/ML INJECTABLE / INJECTION AP RS 2005-04-08 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A076330-002 OCTREOTIDE ACETATE EQ 1MG BASE/ML INJECTABLE / INJECTION AP RS 2005-04-08 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A076330-001 OCTREOTIDE ACETATE EQ 0.2MG BASE/ML INJECTABLE / INJECTION AP RS 2005-04-08 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A076330-002 OCTREOTIDE ACETATE EQ 1MG BASE/ML INJECTABLE / INJECTION AP RS 2005-04-08 782e0a99824c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 82 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Octreotide Acetate
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength OCTREOTIDE ACETATE 200 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 · 5 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 312068 Internal RxNorm lookup 312069 Internal RxNorm lookup 312070 Internal RxNorm lookup 312071 Internal RxNorm lookup 314152 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 0641-6177-01 Octreotide Acetate 5 mL in 1 VIAL, MULTI-DOSE INJECTION, SOLUTION 5 11 0641-6177-01 Octreotide Acetate 1 in 1 CARTON INJECTION, SOLUTION 1 11
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0641-6177 OCTREOTIDE ACETATE INJECTION, SOLUTION [HIKMA PHARMACEUTICALS USA INC.] 10 Current NDC, Legacy NDC, 2 package rows 20250515_9502860d-0261-4d69-a4be-827a5376d356.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 0641-6177-01 00641617701 1 VIAL, MULTI-DOSE in 1 CARTON (0641-6177-01) / 5 mL in 1 VIAL, MULTI-DOSE 2005-04-08 0000-00-00 No No Current