Lanreotide Acetate

Product NDC: 76282-709
Requested package NDC: 76282-709-67
11-digit product format: 762820709
Labeler code: 76282
Product ID: 76282-709_1eaf1cf6-23b6-4c54-8cbf-a96d1f74c4cc
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: lanreotide acetate
Dosage form: INJECTION
Route: SUBCUTANEOUS
Labeler: Exelan Pharmaceuticals, Inc.
Application: NDA215395
Marketing category: NDA
Marketing start: 2022-06-01
Marketing end: 0000-00-00
Substance: LANREOTIDE ACETATE
Active strength: 60 mg/.2mL
Pharmacologic classes: Somatostatin Analog [EPC], Somatostatin Receptor Agonists [MoA]
NDC exclude flag: No
Listing certified through: 2023-12-31
Current FDA listing: Historical FDA.report record

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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	76282-709	76282-709-67	D	Discontinued by firm		2026-08-17

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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	RLD / RS	Approval date
N215395-001	LANREOTIDE ACETATE	LANREOTIDE ACETATE	EQ 60MG BASE/0.2ML (EQ 60MG BASE/0.2ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2021-12-17
N215395-002	LANREOTIDE ACETATE	LANREOTIDE ACETATE	EQ 90MG BASE/0.3ML (EQ 90MG BASE/0.3ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2021-12-17
N215395-003	LANREOTIDE ACETATE	LANREOTIDE ACETATE	EQ 120MG BASE/0.5ML (EQ 120MG BASE/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2021-12-17

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 · 99 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N215395-001	LANREOTIDE ACETATE	EQ 60MG BASE/0.2ML (EQ 60MG BASE/0.2ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2021-12-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215395-002	LANREOTIDE ACETATE	EQ 90MG BASE/0.3ML (EQ 90MG BASE/0.3ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2021-12-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215395-003	LANREOTIDE ACETATE	EQ 120MG BASE/0.5ML (EQ 120MG BASE/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2021-12-17	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N215395-001	LANREOTIDE ACETATE	EQ 60MG BASE/0.2ML (EQ 60MG BASE/0.2ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2021-12-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215395-002	LANREOTIDE ACETATE	EQ 90MG BASE/0.3ML (EQ 90MG BASE/0.3ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2021-12-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215395-003	LANREOTIDE ACETATE	EQ 120MG BASE/0.5ML (EQ 120MG BASE/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2021-12-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215395-001	LANREOTIDE ACETATE	EQ 60MG BASE/0.2ML (EQ 60MG BASE/0.2ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2021-12-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215395-002	LANREOTIDE ACETATE	EQ 90MG BASE/0.3ML (EQ 90MG BASE/0.3ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2021-12-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215395-003	LANREOTIDE ACETATE	EQ 120MG BASE/0.5ML (EQ 120MG BASE/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2021-12-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N215395-001	LANREOTIDE ACETATE	EQ 60MG BASE/0.2ML (EQ 60MG BASE/0.2ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2021-12-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N215395-002	LANREOTIDE ACETATE	EQ 90MG BASE/0.3ML (EQ 90MG BASE/0.3ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2021-12-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N215395-003	LANREOTIDE ACETATE	EQ 120MG BASE/0.5ML (EQ 120MG BASE/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2021-12-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N215395-001	LANREOTIDE ACETATE	EQ 60MG BASE/0.2ML (EQ 60MG BASE/0.2ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2021-12-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N215395-002	LANREOTIDE ACETATE	EQ 90MG BASE/0.3ML (EQ 90MG BASE/0.3ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2021-12-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N215395-003	LANREOTIDE ACETATE	EQ 120MG BASE/0.5ML (EQ 120MG BASE/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2021-12-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N215395-001	LANREOTIDE ACETATE	EQ 60MG BASE/0.2ML (EQ 60MG BASE/0.2ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2021-12-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N215395-002	LANREOTIDE ACETATE	EQ 90MG BASE/0.3ML (EQ 90MG BASE/0.3ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2021-12-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N215395-003	LANREOTIDE ACETATE	EQ 120MG BASE/0.5ML (EQ 120MG BASE/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2021-12-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N215395-001	LANREOTIDE ACETATE	EQ 60MG BASE/0.2ML (EQ 60MG BASE/0.2ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2021-12-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N215395-002	LANREOTIDE ACETATE	EQ 90MG BASE/0.3ML (EQ 90MG BASE/0.3ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2021-12-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N215395-003	LANREOTIDE ACETATE	EQ 120MG BASE/0.5ML (EQ 120MG BASE/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2021-12-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N215395-001	LANREOTIDE ACETATE	EQ 60MG BASE/0.2ML (EQ 60MG BASE/0.2ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2021-12-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N215395-002	LANREOTIDE ACETATE	EQ 90MG BASE/0.3ML (EQ 90MG BASE/0.3ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2021-12-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N215395-003	LANREOTIDE ACETATE	EQ 120MG BASE/0.5ML (EQ 120MG BASE/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2021-12-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N215395-001	LANREOTIDE ACETATE	EQ 60MG BASE/0.2ML (EQ 60MG BASE/0.2ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2021-12-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N215395-002	LANREOTIDE ACETATE	EQ 90MG BASE/0.3ML (EQ 90MG BASE/0.3ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2021-12-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N215395-003	LANREOTIDE ACETATE	EQ 120MG BASE/0.5ML (EQ 120MG BASE/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2021-12-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N215395-001	LANREOTIDE ACETATE	EQ 60MG BASE/0.2ML (EQ 60MG BASE/0.2ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2021-12-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N215395-002	LANREOTIDE ACETATE	EQ 90MG BASE/0.3ML (EQ 90MG BASE/0.3ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2021-12-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N215395-003	LANREOTIDE ACETATE	EQ 120MG BASE/0.5ML (EQ 120MG BASE/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2021-12-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N215395-001	LANREOTIDE ACETATE	EQ 60MG BASE/0.2ML (EQ 60MG BASE/0.2ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2021-12-17	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N215395-002	LANREOTIDE ACETATE	EQ 90MG BASE/0.3ML (EQ 90MG BASE/0.3ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2021-12-17	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N215395-003	LANREOTIDE ACETATE	EQ 120MG BASE/0.5ML (EQ 120MG BASE/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2021-12-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N215395-001	LANREOTIDE ACETATE	EQ 60MG BASE/0.2ML (EQ 60MG BASE/0.2ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2021-12-17	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N215395-002	LANREOTIDE ACETATE	EQ 90MG BASE/0.3ML (EQ 90MG BASE/0.3ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2021-12-17	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N215395-003	LANREOTIDE ACETATE	EQ 120MG BASE/0.5ML (EQ 120MG BASE/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2021-12-17	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N215395-001	LANREOTIDE ACETATE	EQ 60MG BASE/0.2ML (EQ 60MG BASE/0.2ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2021-12-17	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N215395-002	LANREOTIDE ACETATE	EQ 90MG BASE/0.3ML (EQ 90MG BASE/0.3ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2021-12-17	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N215395-003	LANREOTIDE ACETATE	EQ 120MG BASE/0.5ML (EQ 120MG BASE/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2021-12-17	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N215395-001	LANREOTIDE ACETATE	EQ 60MG BASE/0.2ML (EQ 60MG BASE/0.2ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2021-12-17	`1e350fbaab3a…`

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
Lanreotide Acetate	LANREOTIDE ACETATE	Cipla USA Inc.	11da176a-99bc-4ada-8b3f-6bd2b37a6313	2024-09-01	Warnings, Adverse reactions	Exact identifier application applno (NDA): 215395 application number: NDA215395

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
IEU56G3J9C	LANREOTIDE ACETATE	127984-74-1	LANREOTIDE ACETATE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
76282-709-67	76282070967	1 SYRINGE in 1 CARTON (76282-709-67) > .2 mL in 1 SYRINGE	1 syringe	2022-06-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Lanreotide Acetate	Exelan Pharmaceuticals, Inc. \| Pharmathen International S.A.	2022-06-21	HUMAN PRESCRIPTION DRUG LABEL	1