Octreotide Acetate

Product NDC: 25021-467
11-digit product format: 250210467
Labeler code: 25021
Product ID: 25021-467_5e508c59-4170-441a-a94a-70b0bf28b8e4
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: octreotide acetate
Dosage form: INJECTION, SOLUTION
Route: INTRAVENOUS; SUBCUTANEOUS
Labeler: Sagent Pharmaceuticals
Application: ANDA091041
Marketing category: ANDA
Marketing start: 2023-06-15
Substance: OCTREOTIDE ACETATE
Active strength: 1000 ug/mL
Pharmacologic classes: Somatostatin Analog [EPC], Somatostatin Receptor Agonists [MoA]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	25021-467		I	Inactivated by FDA		2026-08-03
excluded package	package	25021-467	25021-467-05	I	Inactivated by FDA		2026-08-03

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
A091041-001	OCTREOTIDE ACETATE	OCTREOTIDE ACETATE	EQ 0.2MG BASE/ML	INJECTABLE / INJECTION	AP		2013-11-12
A091041-002	OCTREOTIDE ACETATE	OCTREOTIDE ACETATE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP		2013-11-12

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A091041-001	AP
A091041-002	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 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A091041-001	OCTREOTIDE ACETATE	EQ 0.2MG BASE/ML	INJECTABLE / INJECTION	AP	2013-11-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091041-002	OCTREOTIDE ACETATE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	2013-11-12	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091041-001	OCTREOTIDE ACETATE	EQ 0.2MG BASE/ML	INJECTABLE / INJECTION	AP	2013-11-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091041-002	OCTREOTIDE ACETATE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	2013-11-12	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091041-001	OCTREOTIDE ACETATE	EQ 0.2MG BASE/ML	INJECTABLE / INJECTION	AP	2013-11-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091041-002	OCTREOTIDE ACETATE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	2013-11-12	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091041-001	OCTREOTIDE ACETATE	EQ 0.2MG BASE/ML	INJECTABLE / INJECTION	AP	2013-11-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091041-002	OCTREOTIDE ACETATE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	2013-11-12	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091041-001	OCTREOTIDE ACETATE	EQ 0.2MG BASE/ML	INJECTABLE / INJECTION	AP	2013-11-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091041-002	OCTREOTIDE ACETATE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	2013-11-12	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091041-001	OCTREOTIDE ACETATE	EQ 0.2MG BASE/ML	INJECTABLE / INJECTION	AP	2013-11-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091041-002	OCTREOTIDE ACETATE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	2013-11-12	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091041-001	OCTREOTIDE ACETATE	EQ 0.2MG BASE/ML	INJECTABLE / INJECTION	AP	2013-11-12	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091041-002	OCTREOTIDE ACETATE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	2013-11-12	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091041-001	OCTREOTIDE ACETATE	EQ 0.2MG BASE/ML	INJECTABLE / INJECTION	AP	2013-11-12	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091041-002	OCTREOTIDE ACETATE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	2013-11-12	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091041-001	OCTREOTIDE ACETATE	EQ 0.2MG BASE/ML	INJECTABLE / INJECTION	AP	2013-11-12	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091041-002	OCTREOTIDE ACETATE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	2013-11-12	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091041-001	OCTREOTIDE ACETATE	EQ 0.2MG BASE/ML	INJECTABLE / INJECTION	AP	2013-11-12	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091041-002	OCTREOTIDE ACETATE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	2013-11-12	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091041-001	OCTREOTIDE ACETATE	EQ 0.2MG BASE/ML	INJECTABLE / INJECTION	AP	2013-11-12	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091041-002	OCTREOTIDE ACETATE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	2013-11-12	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091041-001	OCTREOTIDE ACETATE	EQ 0.2MG BASE/ML	INJECTABLE / INJECTION	AP	2013-11-12	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091041-002	OCTREOTIDE ACETATE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	2013-11-12	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091041-001	OCTREOTIDE ACETATE	EQ 0.2MG BASE/ML	INJECTABLE / INJECTION	AP	2013-11-12	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091041-002	OCTREOTIDE ACETATE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	2013-11-12	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091041-001	OCTREOTIDE ACETATE	EQ 0.2MG BASE/ML	INJECTABLE / INJECTION	AP	2013-11-12	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A091041-002	OCTREOTIDE ACETATE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	2013-11-12	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091041-001	OCTREOTIDE ACETATE	EQ 0.2MG BASE/ML	INJECTABLE / INJECTION	AP	2013-11-12	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091041-002	OCTREOTIDE ACETATE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	2013-11-12	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091041-001	OCTREOTIDE ACETATE	EQ 0.2MG BASE/ML	INJECTABLE / INJECTION	AP	2013-11-12	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A091041-002	OCTREOTIDE ACETATE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	2013-11-12	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091041-001	OCTREOTIDE ACETATE	EQ 0.2MG BASE/ML	INJECTABLE / INJECTION	AP	2013-11-12	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A091041-002	OCTREOTIDE ACETATE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	2013-11-12	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091041-001	OCTREOTIDE ACETATE	EQ 0.2MG BASE/ML	INJECTABLE / INJECTION	AP	2013-11-12	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A091041-002	OCTREOTIDE ACETATE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	2013-11-12	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091041-001	OCTREOTIDE ACETATE	EQ 0.2MG BASE/ML	INJECTABLE / INJECTION	AP	2013-11-12	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A091041-002	OCTREOTIDE ACETATE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	2013-11-12	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A091041-001	OCTREOTIDE ACETATE	EQ 0.2MG BASE/ML	INJECTABLE / INJECTION	AP	2013-11-12	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A091041-002	OCTREOTIDE ACETATE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	2013-11-12	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A091041-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091041-002	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091041-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091041-002	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091041-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091041-002	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091041-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091041-002	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091041-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091041-002	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091041-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091041-002	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091041-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091041-002	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091041-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091041-002	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091041-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091041-002	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091041-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091041-002	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091041-001	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091041-002	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091041-001	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091041-002	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091041-001	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091041-002	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091041-001	AP	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A091041-002	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091041-001	AP	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091041-002	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091041-001	AP	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A091041-002	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091041-001	AP	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A091041-002	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091041-001	AP	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A091041-002	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091041-001	AP	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A091041-002	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A091041-001	AP	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A091041-002	AP	1	`782e0a99824c…`

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
6bd95106-a412-1dad-b9cc-4cb74bfb27ce	Product name	2	20230315
8f3fde6c-976e-4e4c-8ed4-542294fcc0ef	Product name	1	20210115
467fba3a-c020-419e-8102-aeb9c0ea15ec	Product name	1	20200616
48747306-602a-42cc-957b-5b0c69158eee	Product name	1	20180604
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
290f523a-f9db-9774-b5a9-e1f908ac1782	Product name	1	20150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6a	Product name	1	20150324
fc363c46-397b-4476-ac0f-70e43e8e4592	Product name	1	20150324
c6b65c52-69c7-df49-550a-a50c137f6218	Product name	1	20140508
db5ebcdb-b6ae-21cd-4dc5-76cd84b5578b	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
25021-467-05	Octreotide Acetate	5 mL in 1 VIAL	INJECTION, SOLUTION	5		10
25021-467-05	Octreotide Acetate	1 in 1 CARTON	INJECTION, SOLUTION	1		10

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
25021-467-05	ML - Milliliter	25021-467	8a2997dd-9fbc-43f4-8331-e1ee9b3450c6	1	2024-05-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
25021-467	OCTREOTIDE ACETATE INJECTION, SOLUTION [SAGENT PHARMACEUTICALS]	9	Current NDC, Legacy NDC, 2 package rows	20250221_7ce2fc1e-7520-4d04-be45-2baba32ca24a.zip

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	7ce2fc1e-7520-4d04-be45-2baba32ca24a	10
312071	octreotide 1000 MCG/ML Injectable Solution	PSN	7ce2fc1e-7520-4d04-be45-2baba32ca24a	10
314152	octreotide 200 MCG/ML Injectable Solution	PSN	7ce2fc1e-7520-4d04-be45-2baba32ca24a	10
312068	octreotide 50 MCG in 1 ML Injection	PSN	7ce2fc1e-7520-4d04-be45-2baba32ca24a	10
312070	octreotide 500 MCG in 1 ML Injection	PSN	7ce2fc1e-7520-4d04-be45-2baba32ca24a	10
312068	1 ML octreotide 0.05 MG/ML Injection	SCD	7ce2fc1e-7520-4d04-be45-2baba32ca24a	10
312069	1 ML octreotide 0.1 MG/ML Injection	SCD	7ce2fc1e-7520-4d04-be45-2baba32ca24a	10
312070	1 ML octreotide 0.5 MG/ML Injection	SCD	7ce2fc1e-7520-4d04-be45-2baba32ca24a	10
314152	octreotide 0.2 MG/ML Injectable Solution	SCD	7ce2fc1e-7520-4d04-be45-2baba32ca24a	10
312071	octreotide 1 MG/ML Injectable Solution	SCD	7ce2fc1e-7520-4d04-be45-2baba32ca24a	10
312069	1 ML octreotide 100 MCG/ML Injection	SY	7ce2fc1e-7520-4d04-be45-2baba32ca24a	10
312070	1 ML octreotide 500 MCG/ML Injection	SY	7ce2fc1e-7520-4d04-be45-2baba32ca24a	10
312071	octreotide (as octreotide acetate) 1000 MCG/ML Injectable Solution	SY	7ce2fc1e-7520-4d04-be45-2baba32ca24a	10
314152	octreotide (as octreotide acetate) 200 MCG/ML Injectable Solution	SY	7ce2fc1e-7520-4d04-be45-2baba32ca24a	10
312069	octreotide 100 MCG per 1 ML Injection	SY	7ce2fc1e-7520-4d04-be45-2baba32ca24a	10
312068	octreotide 50 MCG per 1 ML Injection	SY	7ce2fc1e-7520-4d04-be45-2baba32ca24a	10
312070	octreotide 500 MCG per 1 ML Injection	SY	7ce2fc1e-7520-4d04-be45-2baba32ca24a	10

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
25021-467-05	25021046705	1 VIAL in 1 CARTON (25021-467-05) / 5 mL in 1 VIAL	1 vial	2023-06-15	0000-00-00	No	No	Current