Lanreotide Acetate

Product NDC: 69097-880
11-digit product format: 690970880
Labeler code: 69097
Product ID: 69097-880_fd205110-15eb-4707-82b2-185e5bbf616b
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: lanreotide acetate
Dosage form: INJECTION
Route: SUBCUTANEOUS
Labeler: Cipla USA Inc.
Application: NDA215395
Marketing category: NDA
Marketing start: 2021-12-24
Substance: LANREOTIDE ACETATE
Active strength: 60 mg/.2mL
Pharmacologic classes: Somatostatin Analog [EPC], Somatostatin Receptor Agonists [MoA]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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…`

Additional Listing Data#

Finished product: Yes
Brand name base: Lanreotide Acetate
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
LANREOTIDE ACETATE	60 mg/.2mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
IEU56G3J9C	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
749811	Internal RxNorm lookup
749814	Internal RxNorm lookup
749817	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
11da176a-99bc-4ada-8b3f-6bd2b37a6313	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
3340e9ad-5e0e-4ddc-aa91-4357df39a30f	Product name	2	20250221
e9869da2-9f36-4263-93de-4156429775d7	Product name	1	20220720

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
69097-880-67	Lanreotide Acetate	1 in 1 CARTON	INJECTION	1		7
69097-880-67	Lanreotide Acetate	0.2 mL in 1 SYRINGE	INJECTION	0.2		7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69097-880	LANREOTIDE ACETATE INJECTION [CIPLA USA INC.]	7	Current NDC, Legacy NDC, 2 package rows	20240925_11da176a-99bc-4ada-8b3f-6bd2b37a6313.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
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 ndc (product): 69097-880

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
749814	lanreotide 120 MG in 0.5 ML Prefilled Syringe	PSN	11da176a-99bc-4ada-8b3f-6bd2b37a6313	7
749811	lanreotide 60 MG in 0.2 ML Prefilled Syringe	PSN	11da176a-99bc-4ada-8b3f-6bd2b37a6313	7
749817	lanreotide 90 MG in 0.3 ML Prefilled Syringe	PSN	11da176a-99bc-4ada-8b3f-6bd2b37a6313	7
749811	0.2 ML lanreotide 300 MG/ML Prefilled Syringe	SCD	11da176a-99bc-4ada-8b3f-6bd2b37a6313	7
749817	0.3 ML lanreotide 300 MG/ML Prefilled Syringe	SCD	11da176a-99bc-4ada-8b3f-6bd2b37a6313	7
749814	0.5 ML lanreotide 240 MG/ML Prefilled Syringe	SCD	11da176a-99bc-4ada-8b3f-6bd2b37a6313	7
749814	0.5 ML lanreotide 240 MG/ML (as lanreotide acetate) Prefilled Syringe	SY	11da176a-99bc-4ada-8b3f-6bd2b37a6313	7
749814	lanreotide 120 MG per 0.5 ML Prefilled Syringe	SY	11da176a-99bc-4ada-8b3f-6bd2b37a6313	7
749811	lanreotide 60 MG per 0.2 ML (as lanreotide acetate) Prefilled Syringe	SY	11da176a-99bc-4ada-8b3f-6bd2b37a6313	7
749817	lanreotide 90 MG per 0.3 ML (as lanreotide acetate) Prefilled Syringe	SY	11da176a-99bc-4ada-8b3f-6bd2b37a6313	7

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
69097-880-67	69097088067	1 SYRINGE in 1 CARTON (69097-880-67) / .2 mL in 1 SYRINGE	1 syringe	2021-12-24	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Lanreotide Acetate	Cipla USA Inc. \| InvaGen Pharmaceuticals, Inc. \| Pharmathen International S.A.	2024-09-01	HUMAN PRESCRIPTION DRUG LABEL	7