Home NDC 0641-6177 Octreotide Acetate
Product NDC 0641-6177
11-digit product format 006416177
Labeler code 0641
Product ID 0641-6177_5beeec13-6cd6-4db5-8e84-f87ada780e6c
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 44 .
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 · 88 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 2026-10-15 13:18:30 2026-09 A076330-001 OCTREOTIDE ACETATE EQ 0.2MG BASE/ML INJECTABLE / INJECTION AP RS 2005-04-08 c2088c7a36db…2026-10-15 13:18:30 2026-09 A076330-002 OCTREOTIDE ACETATE EQ 1MG BASE/ML INJECTABLE / INJECTION AP RS 2005-04-08 c2088c7a36db…2026-09-14 22:38:34 2026-08 A076330-001 OCTREOTIDE ACETATE EQ 0.2MG BASE/ML INJECTABLE / INJECTION AP RS 2005-04-08 84e616aacf4f…2026-09-14 22:38:34 2026-08 A076330-002 OCTREOTIDE ACETATE EQ 1MG BASE/ML INJECTABLE / INJECTION AP RS 2005-04-08 84e616aacf4f…2026-08-18 06:07:40 2026-07 A076330-001 OCTREOTIDE ACETATE EQ 0.2MG BASE/ML INJECTABLE / INJECTION AP RS 2005-04-08 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A076330-002 OCTREOTIDE ACETATE EQ 1MG BASE/ML INJECTABLE / INJECTION AP RS 2005-04-08 caaa826d4ba7…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…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 88 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 200 ug/mL
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
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