Home NDC 0641-6174 Octreotide Acetate
Product NDC 0641-6174
11-digit product format 006416174
Labeler code 0641
Product ID 0641-6174_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 ANDA076313
Marketing category ANDA
Marketing start 2005-04-04
Substance OCTREOTIDE ACETATE
Active strength 50 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 43 .
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 A076313-001 OCTREOTIDE ACETATE (PRESERVATIVE FREE) OCTREOTIDE ACETATE EQ 0.05MG BASE/ML INJECTABLE / INJECTION AP RS 2005-03-28 A076313-002 OCTREOTIDE ACETATE (PRESERVATIVE FREE) OCTREOTIDE ACETATE EQ 0.5MG BASE/ML INJECTABLE / INJECTION AP RS 2005-03-28 A076313-003 OCTREOTIDE ACETATE (PRESERVATIVE FREE) OCTREOTIDE ACETATE EQ 0.1MG BASE/ML INJECTABLE / INJECTION AP RS 2005-03-28
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 · 129 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 2026-09-14 22:38:34 2026-08 A076313-001 OCTREOTIDE ACETATE (PRESERVATIVE FREE) EQ 0.05MG BASE/ML INJECTABLE / INJECTION AP RS 2005-03-28 84e616aacf4f…2026-09-14 22:38:34 2026-08 A076313-002 OCTREOTIDE ACETATE (PRESERVATIVE FREE) EQ 0.5MG BASE/ML INJECTABLE / INJECTION AP RS 2005-03-28 84e616aacf4f…2026-09-14 22:38:34 2026-08 A076313-003 OCTREOTIDE ACETATE (PRESERVATIVE FREE) EQ 0.1MG BASE/ML INJECTABLE / INJECTION AP RS 2005-03-28 84e616aacf4f…2026-08-18 06:07:40 2026-07 A076313-001 OCTREOTIDE ACETATE (PRESERVATIVE FREE) EQ 0.05MG BASE/ML INJECTABLE / INJECTION AP RS 2005-03-28 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A076313-002 OCTREOTIDE ACETATE (PRESERVATIVE FREE) EQ 0.5MG BASE/ML INJECTABLE / INJECTION AP RS 2005-03-28 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A076313-003 OCTREOTIDE ACETATE (PRESERVATIVE FREE) EQ 0.1MG BASE/ML INJECTABLE / INJECTION AP RS 2005-03-28 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A076313-001 OCTREOTIDE ACETATE (PRESERVATIVE FREE) EQ 0.05MG BASE/ML INJECTABLE / INJECTION AP RS 2005-03-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A076313-002 OCTREOTIDE ACETATE (PRESERVATIVE FREE) EQ 0.5MG BASE/ML INJECTABLE / INJECTION AP RS 2005-03-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A076313-003 OCTREOTIDE ACETATE (PRESERVATIVE FREE) EQ 0.1MG BASE/ML INJECTABLE / INJECTION AP RS 2005-03-28 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076313-001 OCTREOTIDE ACETATE (PRESERVATIVE FREE) EQ 0.05MG BASE/ML INJECTABLE / INJECTION AP RS 2005-03-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076313-002 OCTREOTIDE ACETATE (PRESERVATIVE FREE) EQ 0.5MG BASE/ML INJECTABLE / INJECTION AP RS 2005-03-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076313-003 OCTREOTIDE ACETATE (PRESERVATIVE FREE) EQ 0.1MG BASE/ML INJECTABLE / INJECTION AP RS 2005-03-28 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A076313-001 OCTREOTIDE ACETATE (PRESERVATIVE FREE) EQ 0.05MG BASE/ML INJECTABLE / INJECTION AP RS 2005-03-28 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A076313-002 OCTREOTIDE ACETATE (PRESERVATIVE FREE) EQ 0.5MG BASE/ML INJECTABLE / INJECTION AP RS 2005-03-28 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A076313-003 OCTREOTIDE ACETATE (PRESERVATIVE FREE) EQ 0.1MG BASE/ML INJECTABLE / INJECTION AP RS 2005-03-28 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076313-001 OCTREOTIDE ACETATE (PRESERVATIVE FREE) EQ 0.05MG BASE/ML INJECTABLE / INJECTION AP RS 2005-03-28 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076313-002 OCTREOTIDE ACETATE (PRESERVATIVE FREE) EQ 0.5MG BASE/ML INJECTABLE / INJECTION AP RS 2005-03-28 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076313-003 OCTREOTIDE ACETATE (PRESERVATIVE FREE) EQ 0.1MG BASE/ML INJECTABLE / INJECTION AP RS 2005-03-28 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076313-001 OCTREOTIDE ACETATE (PRESERVATIVE FREE) EQ 0.05MG BASE/ML INJECTABLE / INJECTION AP RS 2005-03-28 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076313-002 OCTREOTIDE ACETATE (PRESERVATIVE FREE) EQ 0.5MG BASE/ML INJECTABLE / INJECTION AP RS 2005-03-28 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076313-003 OCTREOTIDE ACETATE (PRESERVATIVE FREE) EQ 0.1MG BASE/ML INJECTABLE / INJECTION AP RS 2005-03-28 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076313-001 OCTREOTIDE ACETATE (PRESERVATIVE FREE) EQ 0.05MG BASE/ML INJECTABLE / INJECTION AP RS 2005-03-28 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076313-002 OCTREOTIDE ACETATE (PRESERVATIVE FREE) EQ 0.5MG BASE/ML INJECTABLE / INJECTION AP RS 2005-03-28 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076313-003 OCTREOTIDE ACETATE (PRESERVATIVE FREE) EQ 0.1MG BASE/ML INJECTABLE / INJECTION AP RS 2005-03-28 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076313-001 OCTREOTIDE ACETATE (PRESERVATIVE FREE) EQ 0.05MG BASE/ML INJECTABLE / INJECTION AP RS 2005-03-28 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076313-002 OCTREOTIDE ACETATE (PRESERVATIVE FREE) EQ 0.5MG BASE/ML INJECTABLE / INJECTION AP RS 2005-03-28 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076313-003 OCTREOTIDE ACETATE (PRESERVATIVE FREE) EQ 0.1MG BASE/ML INJECTABLE / INJECTION AP RS 2005-03-28 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076313-001 OCTREOTIDE ACETATE (PRESERVATIVE FREE) EQ 0.05MG BASE/ML INJECTABLE / INJECTION AP RS 2005-03-28 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076313-002 OCTREOTIDE ACETATE (PRESERVATIVE FREE) EQ 0.5MG BASE/ML INJECTABLE / INJECTION AP RS 2005-03-28 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076313-003 OCTREOTIDE ACETATE (PRESERVATIVE FREE) EQ 0.1MG BASE/ML INJECTABLE / INJECTION AP RS 2005-03-28 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076313-001 OCTREOTIDE ACETATE (PRESERVATIVE FREE) EQ 0.05MG BASE/ML INJECTABLE / INJECTION AP RS 2005-03-28 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076313-002 OCTREOTIDE ACETATE (PRESERVATIVE FREE) EQ 0.5MG BASE/ML INJECTABLE / INJECTION AP RS 2005-03-28 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076313-003 OCTREOTIDE ACETATE (PRESERVATIVE FREE) EQ 0.1MG BASE/ML INJECTABLE / INJECTION AP RS 2005-03-28 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A076313-001 OCTREOTIDE ACETATE (PRESERVATIVE FREE) EQ 0.05MG BASE/ML INJECTABLE / INJECTION AP RS 2005-03-28 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A076313-002 OCTREOTIDE ACETATE (PRESERVATIVE FREE) EQ 0.5MG BASE/ML INJECTABLE / INJECTION AP RS 2005-03-28 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A076313-003 OCTREOTIDE ACETATE (PRESERVATIVE FREE) EQ 0.1MG BASE/ML INJECTABLE / INJECTION AP RS 2005-03-28 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A076313-001 OCTREOTIDE ACETATE (PRESERVATIVE FREE) EQ 0.05MG BASE/ML INJECTABLE / INJECTION AP RS 2005-03-28 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A076313-002 OCTREOTIDE ACETATE (PRESERVATIVE FREE) EQ 0.5MG BASE/ML INJECTABLE / INJECTION AP RS 2005-03-28 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A076313-003 OCTREOTIDE ACETATE (PRESERVATIVE FREE) EQ 0.1MG BASE/ML INJECTABLE / INJECTION AP RS 2005-03-28 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A076313-001 OCTREOTIDE ACETATE (PRESERVATIVE FREE) EQ 0.05MG BASE/ML INJECTABLE / INJECTION AP RS 2005-03-28 301d65b070ca…
Observed Orange Book normalized TE history# Normalized TE history page 4 of 4 · 129 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
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 50 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 0641-6174-01 Octreotide Acetate 1 mL in 1 VIAL, SINGLE-DOSE INJECTION, SOLUTION 1 11 0641-6174-10 Octreotide Acetate 10 in 1 CARTON INJECTION, SOLUTION 10 11
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0641-6174 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 Units Marketing start Marketing end Sample Exclude flag Status 0641-6174-01 00641617401 1 mL in 1 VIAL, SINGLE-DOSE 1 ml Historical 0641-6174-10 00641617410 10 VIAL, SINGLE-DOSE in 1 CARTON (0641-6174-10) / 1 mL in 1 VIAL, SINGLE-DOSE (0641-6174-01) 2005-04-04 0000-00-00 No No Current