Octreotide Acetate

Product NDC: 0641-6174
11-digit product format: 006416174
Labeler code: 0641
Product ID: 0641-6174_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: 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 44.

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.

Application-product, TE code table
Application-product	TE code
A076313-001	AP
A076313-002	AP
A076313-003	AP

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 · 132 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	A076313-001	OCTREOTIDE ACETATE (PRESERVATIVE FREE)	EQ 0.05MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2005-03-28	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A076313-002	OCTREOTIDE ACETATE (PRESERVATIVE FREE)	EQ 0.5MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2005-03-28	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A076313-003	OCTREOTIDE ACETATE (PRESERVATIVE FREE)	EQ 0.1MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2005-03-28	`c2088c7a36db…`
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…`

Observed Orange Book normalized TE history#

Normalized TE history page 3 of 4 · 132 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2020-11-12 02:37 UTC	2020-11	A076313-003	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076313-001	AP	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A076313-002	AP	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A076313-003	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076313-001	AP	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A076313-002	AP	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A076313-003	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076313-001	AP	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A076313-002	AP	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A076313-003	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076313-001	AP	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076313-002	AP	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076313-003	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A076313-001	AP	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A076313-002	AP	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A076313-003	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A076313-001	AP	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A076313-002	AP	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A076313-003	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076313-001	AP	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076313-002	AP	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076313-003	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076313-001	AP	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076313-002	AP	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076313-003	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076313-001	AP	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076313-002	AP	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076313-003	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076313-001	AP	1	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076313-002	AP	1	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076313-003	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A076313-001	AP	1	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A076313-002	AP	1	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A076313-003	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A076313-001	AP	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A076313-002	AP	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A076313-003	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076313-001	AP	1	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076313-002	AP	1	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076313-003	AP	1	`3a93d1ddd44b…`

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
813db1d8-6534-4d2d-be9e-8d2c20a55eda	Product name	1	20241217
a6ddfef5-d553-2919-73fa-8aede2a8ab27	Product name	5	20240823
8f3fde6c-976e-4e4c-8ed4-542294fcc0ef	Product name	1	20210115
467fba3a-c020-419e-8102-aeb9c0ea15ec	Product name	1	20200616

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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0641-6174-01	ML - Milliliter	0641-6174	dcde1d97-f379-413a-9ebe-59e8b9d53d7d	1	2017-11-06
0641-6174-10	ML - Milliliter	0641-6174	5e677fb4-7c12-42af-90d7-de4dc9fedd5d	1	2017-11-06

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.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Octreotide Acetate	OCTREOTIDE ACETATE	Hikma Pharmaceuticals USA Inc.	9502860d-0261-4d69-a4be-827a5376d356	2024-03-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076313 application number: ANDA076313 ndc (product): 0641-6174

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
75R0U2568I	OCTREOTIDE ACETATE	79517-01-4	OCTREOTIDE ACETATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
312069	octreotide 100 MCG in 1 ML Injection	PSN	9502860d-0261-4d69-a4be-827a5376d356	11
312071	octreotide 1000 MCG/ML Injectable Solution	PSN	9502860d-0261-4d69-a4be-827a5376d356	11
314152	octreotide 200 MCG/ML Injectable Solution	PSN	9502860d-0261-4d69-a4be-827a5376d356	11
312068	octreotide 50 MCG in 1 ML Injection	PSN	9502860d-0261-4d69-a4be-827a5376d356	11
312070	octreotide 500 MCG in 1 ML Injection	PSN	9502860d-0261-4d69-a4be-827a5376d356	11
312068	1 ML octreotide 0.05 MG/ML Injection	SCD	9502860d-0261-4d69-a4be-827a5376d356	11
312069	1 ML octreotide 0.1 MG/ML Injection	SCD	9502860d-0261-4d69-a4be-827a5376d356	11
312070	1 ML octreotide 0.5 MG/ML Injection	SCD	9502860d-0261-4d69-a4be-827a5376d356	11
314152	octreotide 0.2 MG/ML Injectable Solution	SCD	9502860d-0261-4d69-a4be-827a5376d356	11
312071	octreotide 1 MG/ML Injectable Solution	SCD	9502860d-0261-4d69-a4be-827a5376d356	11
312069	1 ML octreotide 100 MCG/ML Injection	SY	9502860d-0261-4d69-a4be-827a5376d356	11
312070	1 ML octreotide 500 MCG/ML Injection	SY	9502860d-0261-4d69-a4be-827a5376d356	11
312071	octreotide (as octreotide acetate) 1000 MCG/ML Injectable Solution	SY	9502860d-0261-4d69-a4be-827a5376d356	11
314152	octreotide (as octreotide acetate) 200 MCG/ML Injectable Solution	SY	9502860d-0261-4d69-a4be-827a5376d356	11
312069	octreotide 100 MCG per 1 ML Injection	SY	9502860d-0261-4d69-a4be-827a5376d356	11
312068	octreotide 50 MCG per 1 ML Injection	SY	9502860d-0261-4d69-a4be-827a5376d356	11
312070	octreotide 500 MCG per 1 ML Injection	SY	9502860d-0261-4d69-a4be-827a5376d356	11

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