Octreotide Acetate

Product NDC: 0641-6175
11-digit product format: 006416175
Labeler code: 0641
Product ID: 0641-6175_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: 100 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 1 of 4 · 132 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-10-15 13:18:30	2026-09	A076313-001	AP	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A076313-002	AP	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A076313-003	AP	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A076313-001	AP	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076313-002	AP	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076313-003	AP	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A076313-001	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076313-002	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076313-003	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076313-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076313-002	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076313-003	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076313-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076313-002	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076313-003	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076313-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076313-002	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076313-003	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076313-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076313-002	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076313-003	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076313-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076313-002	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076313-003	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076313-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076313-002	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076313-003	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076313-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076313-002	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076313-003	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076313-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076313-002	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076313-003	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076313-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076313-002	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076313-003	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076313-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076313-002	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076313-003	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076313-001	AP	1	`79d66fd596c7…`

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	100 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
0641-6175-01	Octreotide Acetate	1 mL in 1 VIAL, SINGLE-DOSE	INJECTION, SOLUTION	1		11
0641-6175-10	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
0641-6175-01	ML - Milliliter	0641-6175	af4fa342-986c-468f-9037-597bbb43a429	1	2017-11-06
0641-6175-10	ML - Milliliter	0641-6175	be053844-b2ea-4a68-9977-b6cbb78b6809	1	2017-11-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0641-6175	OCTREOTIDE ACETATE INJECTION, SOLUTION [HIKMA PHARMACEUTICALS USA INC.]	10	Current NDC, Legacy NDC, 2 package rows	20250515_9502860d-0261-4d69-a4be-827a5376d356.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	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
0641-6175-01	00641617501	1 mL in 1 VIAL, SINGLE-DOSE	1 ml					Historical
0641-6175-10	00641617510	10 VIAL, SINGLE-DOSE in 1 CARTON (0641-6175-10) / 1 mL in 1 VIAL, SINGLE-DOSE (0641-6175-01)		2005-04-04	0000-00-00	No	No	Current