SOMATULINE DEPOT

Product NDC: 15054-1060
11-digit product format: 150541060
Labeler code: 15054
Product ID: 15054-1060_1cafe88a-b7a2-42ff-bb99-3dd17538c58b
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: lanreotide acetate
Dosage form: INJECTION
Route: SUBCUTANEOUS
Labeler: Ipsen Biopharmaceuticals, Inc.
Application: NDA022074
Marketing category: NDA
Marketing start: 2007-11-14
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 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
N022074-001	SOMATULINE DEPOT	LANREOTIDE ACETATE	EQ 60MG BASE/0.2ML (EQ 60MG BASE/0.2ML)	SOLUTION / SUBCUTANEOUS		RLD, RS	2007-08-30
N022074-002	SOMATULINE DEPOT	LANREOTIDE ACETATE	EQ 90MG BASE/0.3ML (EQ 90MG BASE/0.3ML)	SOLUTION / SUBCUTANEOUS		RLD, RS	2007-08-30
N022074-003	SOMATULINE DEPOT	LANREOTIDE ACETATE	EQ 120MG BASE/0.5ML (EQ 120MG BASE/0.5ML)	SOLUTION / SUBCUTANEOUS	AB	RLD, RS	2007-08-30

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N022074-003	AB

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	N022074-001	SOMATULINE DEPOT	EQ 60MG BASE/0.2ML (EQ 60MG BASE/0.2ML)	SOLUTION / SUBCUTANEOUS		RLD, RS	2007-08-30	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N022074-002	SOMATULINE DEPOT	EQ 90MG BASE/0.3ML (EQ 90MG BASE/0.3ML)	SOLUTION / SUBCUTANEOUS		RLD, RS	2007-08-30	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N022074-003	SOMATULINE DEPOT	EQ 120MG BASE/0.5ML (EQ 120MG BASE/0.5ML)	SOLUTION / SUBCUTANEOUS	AB	RLD, RS	2007-08-30	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N022074-001	SOMATULINE DEPOT	EQ 60MG BASE/0.2ML (EQ 60MG BASE/0.2ML)	SOLUTION / SUBCUTANEOUS	AB	RLD, RS	2007-08-30	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022074-002	SOMATULINE DEPOT	EQ 90MG BASE/0.3ML (EQ 90MG BASE/0.3ML)	SOLUTION / SUBCUTANEOUS	AB	RLD, RS	2007-08-30	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022074-003	SOMATULINE DEPOT	EQ 120MG BASE/0.5ML (EQ 120MG BASE/0.5ML)	SOLUTION / SUBCUTANEOUS	AB	RLD, RS	2007-08-30	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N022074-001	SOMATULINE DEPOT	EQ 60MG BASE/0.2ML (EQ 60MG BASE/0.2ML)	SOLUTION / SUBCUTANEOUS	AB	RLD, RS	2007-08-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022074-002	SOMATULINE DEPOT	EQ 90MG BASE/0.3ML (EQ 90MG BASE/0.3ML)	SOLUTION / SUBCUTANEOUS	AB	RLD, RS	2007-08-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022074-003	SOMATULINE DEPOT	EQ 120MG BASE/0.5ML (EQ 120MG BASE/0.5ML)	SOLUTION / SUBCUTANEOUS	AB	RLD, RS	2007-08-30	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N022074-001	SOMATULINE DEPOT	EQ 60MG BASE/0.2ML (EQ 60MG BASE/0.2ML)	SOLUTION / SUBCUTANEOUS	AB	RLD, RS	2007-08-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022074-002	SOMATULINE DEPOT	EQ 90MG BASE/0.3ML (EQ 90MG BASE/0.3ML)	SOLUTION / SUBCUTANEOUS	AB	RLD, RS	2007-08-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022074-003	SOMATULINE DEPOT	EQ 120MG BASE/0.5ML (EQ 120MG BASE/0.5ML)	SOLUTION / SUBCUTANEOUS	AB	RLD, RS	2007-08-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022074-001	SOMATULINE DEPOT	EQ 60MG BASE/0.2ML (EQ 60MG BASE/0.2ML)	SOLUTION / SUBCUTANEOUS	AB	RLD, RS	2007-08-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022074-002	SOMATULINE DEPOT	EQ 90MG BASE/0.3ML (EQ 90MG BASE/0.3ML)	SOLUTION / SUBCUTANEOUS	AB	RLD, RS	2007-08-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022074-003	SOMATULINE DEPOT	EQ 120MG BASE/0.5ML (EQ 120MG BASE/0.5ML)	SOLUTION / SUBCUTANEOUS	AB	RLD, RS	2007-08-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022074-001	SOMATULINE DEPOT	EQ 60MG BASE/0.2ML (EQ 60MG BASE/0.2ML)	SOLUTION / SUBCUTANEOUS	AB	RLD, RS	2007-08-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022074-002	SOMATULINE DEPOT	EQ 90MG BASE/0.3ML (EQ 90MG BASE/0.3ML)	SOLUTION / SUBCUTANEOUS	AB	RLD, RS	2007-08-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022074-003	SOMATULINE DEPOT	EQ 120MG BASE/0.5ML (EQ 120MG BASE/0.5ML)	SOLUTION / SUBCUTANEOUS	AB	RLD, RS	2007-08-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022074-001	SOMATULINE DEPOT	EQ 60MG BASE/0.2ML (EQ 60MG BASE/0.2ML)	SOLUTION / SUBCUTANEOUS	AB	RLD, RS	2007-08-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022074-002	SOMATULINE DEPOT	EQ 90MG BASE/0.3ML (EQ 90MG BASE/0.3ML)	SOLUTION / SUBCUTANEOUS	AB	RLD, RS	2007-08-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022074-003	SOMATULINE DEPOT	EQ 120MG BASE/0.5ML (EQ 120MG BASE/0.5ML)	SOLUTION / SUBCUTANEOUS	AB	RLD, RS	2007-08-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022074-001	SOMATULINE DEPOT	EQ 60MG BASE/0.2ML (EQ 60MG BASE/0.2ML)	SOLUTION / SUBCUTANEOUS	AB	RLD, RS	2007-08-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022074-002	SOMATULINE DEPOT	EQ 90MG BASE/0.3ML (EQ 90MG BASE/0.3ML)	SOLUTION / SUBCUTANEOUS	AB	RLD, RS	2007-08-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022074-003	SOMATULINE DEPOT	EQ 120MG BASE/0.5ML (EQ 120MG BASE/0.5ML)	SOLUTION / SUBCUTANEOUS	AB	RLD, RS	2007-08-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022074-001	SOMATULINE DEPOT	EQ 60MG BASE/0.2ML (EQ 60MG BASE/0.2ML)	SOLUTION / SUBCUTANEOUS	AB	RLD, RS	2007-08-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022074-002	SOMATULINE DEPOT	EQ 90MG BASE/0.3ML (EQ 90MG BASE/0.3ML)	SOLUTION / SUBCUTANEOUS	AB	RLD, RS	2007-08-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022074-003	SOMATULINE DEPOT	EQ 120MG BASE/0.5ML (EQ 120MG BASE/0.5ML)	SOLUTION / SUBCUTANEOUS	AB	RLD, RS	2007-08-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022074-001	SOMATULINE DEPOT	EQ 60MG BASE/0.2ML (EQ 60MG BASE/0.2ML)	SOLUTION / SUBCUTANEOUS	AB	RLD, RS	2007-08-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022074-002	SOMATULINE DEPOT	EQ 90MG BASE/0.3ML (EQ 90MG BASE/0.3ML)	SOLUTION / SUBCUTANEOUS	AB	RLD, RS	2007-08-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022074-003	SOMATULINE DEPOT	EQ 120MG BASE/0.5ML (EQ 120MG BASE/0.5ML)	SOLUTION / SUBCUTANEOUS	AB	RLD, RS	2007-08-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022074-001	SOMATULINE DEPOT	EQ 60MG BASE/0.2ML (EQ 60MG BASE/0.2ML)	SOLUTION / SUBCUTANEOUS	AB	RLD, RS	2007-08-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022074-002	SOMATULINE DEPOT	EQ 90MG BASE/0.3ML (EQ 90MG BASE/0.3ML)	SOLUTION / SUBCUTANEOUS	AB	RLD, RS	2007-08-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022074-003	SOMATULINE DEPOT	EQ 120MG BASE/0.5ML (EQ 120MG BASE/0.5ML)	SOLUTION / SUBCUTANEOUS	AB	RLD, RS	2007-08-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022074-001	SOMATULINE DEPOT	EQ 60MG BASE/0.2ML (EQ 60MG BASE/0.2ML)	SOLUTION / SUBCUTANEOUS	AB	RLD, RS	2007-08-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022074-002	SOMATULINE DEPOT	EQ 90MG BASE/0.3ML (EQ 90MG BASE/0.3ML)	SOLUTION / SUBCUTANEOUS	AB	RLD, RS	2007-08-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022074-003	SOMATULINE DEPOT	EQ 120MG BASE/0.5ML (EQ 120MG BASE/0.5ML)	SOLUTION / SUBCUTANEOUS	AB	RLD, RS	2007-08-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022074-001	SOMATULINE DEPOT	EQ 60MG BASE/0.2ML (EQ 60MG BASE/0.2ML)	SOLUTION / SUBCUTANEOUS	AB	RLD, RS	2007-08-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022074-002	SOMATULINE DEPOT	EQ 90MG BASE/0.3ML (EQ 90MG BASE/0.3ML)	SOLUTION / SUBCUTANEOUS	AB	RLD, RS	2007-08-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022074-003	SOMATULINE DEPOT	EQ 120MG BASE/0.5ML (EQ 120MG BASE/0.5ML)	SOLUTION / SUBCUTANEOUS	AB	RLD, RS	2007-08-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022074-001	SOMATULINE DEPOT	EQ 60MG BASE/0.2ML (EQ 60MG BASE/0.2ML)	SOLUTION / SUBCUTANEOUS	AB	RLD, RS	2007-08-30	`79d66fd596c7…`

Observed Orange Book normalized TE history#

Normalized TE history page 2 of 2 · 49 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022074-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022074-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022074-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022074-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022074-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022074-003	AB	1	`1e350fbaab3a…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N022074-001	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N022074-002	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N022074-003	AB	1	`a50c72e98297…`

Observed Orange Book patent history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N022074-001	5595760	2020-03-08	U-831	Drug product	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022074-002	5595760	2020-03-08	U-831	Drug product	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022074-003	5595760	2020-03-08	U-831	Drug product	`74a2ff9319b5…`
2020-12-22 03:56 UTC	2020-12	N022074-001	5595760	2020-03-08	U-831	Drug product	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N022074-002	5595760	2020-03-08	U-831	Drug product	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N022074-003	5595760	2020-03-08	U-831	Drug product	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N022074-001	5595760	2020-03-08	U-831	Drug product	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N022074-002	5595760	2020-03-08	U-831	Drug product	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N022074-003	5595760	2020-03-08	U-831	Drug product	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N022074-001	5595760	2020-03-08	U-831	Drug product	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N022074-002	5595760	2020-03-08	U-831	Drug product	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N022074-003	5595760	2020-03-08	U-831	Drug product	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N022074-001	5595760	2020-03-08	U-831	Drug product	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N022074-002	5595760	2020-03-08	U-831	Drug product	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N022074-003	5595760	2020-03-08	U-831	Drug product	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N022074-001	5595760	2020-03-08	U-831	Drug product	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N022074-002	5595760	2020-03-08	U-831	Drug product	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N022074-003	5595760	2020-03-08	U-831	Drug product	`ea99ee380514…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 4 · 150 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022074-001	ODE-156	2024-09-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022074-002	ODE-156	2024-09-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022074-003	ODE-156	2024-09-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022074-001	ODE-156	2024-09-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022074-002	ODE-156	2024-09-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022074-003	ODE-156	2024-09-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022074-001	ODE-156	2024-09-15	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022074-002	ODE-156	2024-09-15	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022074-003	ODE-156	2024-09-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022074-001	ODE-156	2024-09-15	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022074-002	ODE-156	2024-09-15	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022074-003	ODE-156	2024-09-15	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022074-001	ODE-156	2024-09-15	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022074-002	ODE-156	2024-09-15	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022074-003	ODE-156	2024-09-15	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022074-001	ODE-156	2024-09-15	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022074-002	ODE-156	2024-09-15	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022074-003	ODE-156	2024-09-15	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022074-001	ODE-156	2024-09-15	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022074-002	ODE-156	2024-09-15	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022074-003	ODE-156	2024-09-15	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022074-001	ODE-156	2024-09-15	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022074-002	ODE-156	2024-09-15	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022074-003	ODE-156	2024-09-15	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022074-001	ODE-156	2024-09-15	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N022074-002	ODE-156	2024-09-15	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N022074-003	ODE-156	2024-09-15	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022074-001	ODE-156	2024-09-15	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022074-002	ODE-156	2024-09-15	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022074-003	ODE-156	2024-09-15	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022074-001	ODE-156	2024-09-15	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N022074-002	ODE-156	2024-09-15	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N022074-003	ODE-156	2024-09-15	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022074-001	ODE-156	2024-09-15	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N022074-002	ODE-156	2024-09-15	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N022074-003	ODE-156	2024-09-15	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N022074-001	I-754	2020-09-15	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022074-001	ODE-82	2021-12-16	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022074-001	ODE-156	2024-09-15	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022074-002	I-754	2020-09-15	`74a2ff9319b5…`

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: SOMATULINE DEPOT
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 · 6 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
749811	Internal RxNorm lookup
749813	Internal RxNorm lookup
749814	Internal RxNorm lookup
749816	Internal RxNorm lookup
749817	Internal RxNorm lookup
749818	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
6e4a41fd-a753-4362-87ee-8cc56ed3660d	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
48747306-602a-42cc-957b-5b0c69158eee	Product name	1	20180604
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
15054-1060-4	SOMATULINE DEPOT	1 in 1 POUCH	INJECTION	1		16
15054-1060-4	SOMATULINE DEPOT	1 in 1 CARTON	INJECTION	1		16

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
15054-1060-3	ML - Milliliter	15054-1060	099aae71-411c-4414-8c88-f5b7b4d2247a	1	2015-01-05
15054-1060-4	ML - Milliliter	15054-1060	60afe3bb-9286-4770-893f-f31746bf164d	1	2019-10-07

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
lanreotide acetate	ACTIVE INGREDIENT	IEU56G3J9C	SOMATULINE DEPOT (LANREOTIDE ACETATE) INJECTION [IPSEN BIOPHARMACEUTICALS, INC.]	2
lanreotide	ACTIVE MOIETY	0G3DE8943Y	SOMATULINE DEPOT (LANREOTIDE ACETATE) INJECTION [IPSEN BIOPHARMACEUTICALS, INC.]	2
Water	INACTIVE INGREDIENT	059QF0KO0R	SOMATULINE DEPOT (LANREOTIDE ACETATE) INJECTION [IPSEN BIOPHARMACEUTICALS, INC.]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
15054-1060	SOMATULINE DEPOT (LANREOTIDE ACETATE) INJECTION [IPSEN BIOPHARMACEUTICALS, INC.]	16	Current NDC, Legacy NDC, 2 package rows	20241017_6e4a41fd-a753-4362-87ee-8cc56ed3660d.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
SOMATULINE DEPOT	LANREOTIDE ACETATE	Ipsen Biopharmaceuticals, Inc.	6e4a41fd-a753-4362-87ee-8cc56ed3660d	2024-10-11	Warnings, Adverse reactions	Exact identifier application applno (NDA): 022074 application number: NDA022074 ndc (product): 15054-1060

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	6e4a41fd-a753-4362-87ee-8cc56ed3660d	16
749811	lanreotide 60 MG in 0.2 ML Prefilled Syringe	PSN	6e4a41fd-a753-4362-87ee-8cc56ed3660d	16
749817	lanreotide 90 MG in 0.3 ML Prefilled Syringe	PSN	6e4a41fd-a753-4362-87ee-8cc56ed3660d	16
749816	Somatuline Depot 120 MG in 0.5 ML Prefilled Syringe	PSN	6e4a41fd-a753-4362-87ee-8cc56ed3660d	16
749813	Somatuline Depot 60 MG in 0.2 ML Prefilled Syringe	PSN	6e4a41fd-a753-4362-87ee-8cc56ed3660d	16
749818	Somatuline Depot 90 MG in 0.3 ML Prefilled Syringe	PSN	6e4a41fd-a753-4362-87ee-8cc56ed3660d	16
749813	0.2 ML lanreotide 300 MG/ML Prefilled Syringe [Somatuline]	SBD	6e4a41fd-a753-4362-87ee-8cc56ed3660d	16
749818	0.3 ML lanreotide 300 MG/ML Prefilled Syringe [Somatuline]	SBD	6e4a41fd-a753-4362-87ee-8cc56ed3660d	16
749816	0.5 ML lanreotide 240 MG/ML Prefilled Syringe [Somatuline]	SBD	6e4a41fd-a753-4362-87ee-8cc56ed3660d	16
749811	0.2 ML lanreotide 300 MG/ML Prefilled Syringe	SCD	6e4a41fd-a753-4362-87ee-8cc56ed3660d	16
749817	0.3 ML lanreotide 300 MG/ML Prefilled Syringe	SCD	6e4a41fd-a753-4362-87ee-8cc56ed3660d	16
749814	0.5 ML lanreotide 240 MG/ML Prefilled Syringe	SCD	6e4a41fd-a753-4362-87ee-8cc56ed3660d	16
749813	0.2 ML Somatuline 300 MG/ML (as lanreotide acetate) Prefilled Syringe	SY	6e4a41fd-a753-4362-87ee-8cc56ed3660d	16
749813	0.2 ML Somatuline 300 MG/ML Prefilled Syringe	SY	6e4a41fd-a753-4362-87ee-8cc56ed3660d	16
749818	0.3 ML Somatuline 300 MG/ML (as lanreotide acetate) Prefilled Syringe	SY	6e4a41fd-a753-4362-87ee-8cc56ed3660d	16
749818	0.3 ML Somatuline 300 MG/ML Prefilled Syringe	SY	6e4a41fd-a753-4362-87ee-8cc56ed3660d	16
749816	0.5 ML lanreotide 240 MG/ML ( as lanreotide acetate) Prefilled Syringe [Somatuline]	SY	6e4a41fd-a753-4362-87ee-8cc56ed3660d	16
749814	0.5 ML lanreotide 240 MG/ML (as lanreotide acetate) Prefilled Syringe	SY	6e4a41fd-a753-4362-87ee-8cc56ed3660d	16
749814	lanreotide 120 MG per 0.5 ML Prefilled Syringe	SY	6e4a41fd-a753-4362-87ee-8cc56ed3660d	16
749811	lanreotide 60 MG per 0.2 ML (as lanreotide acetate) Prefilled Syringe	SY	6e4a41fd-a753-4362-87ee-8cc56ed3660d	16
749817	lanreotide 90 MG per 0.3 ML (as lanreotide acetate) Prefilled Syringe	SY	6e4a41fd-a753-4362-87ee-8cc56ed3660d	16
749816	Somatuline Depot 120 MG per 0.5 ML Prefilled Syringe	SY	6e4a41fd-a753-4362-87ee-8cc56ed3660d	16
749813	Somatuline Depot 60 MG per 0.2 ML Prefilled Syringe	SY	6e4a41fd-a753-4362-87ee-8cc56ed3660d	16
749818	Somatuline Depot 90 MG per 0.3 ML Prefilled Syringe	SY	6e4a41fd-a753-4362-87ee-8cc56ed3660d	16

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
15054-1060-3	15054106003	1 POUCH in 1 CARTON (15054-1060-3) > 1 SYRINGE in 1 POUCH > .2 mL in 1 SYRINGE	1 pouch	2007-11-14	2022-06-30	No	No	Current
15054-1060-4	15054106004	1 POUCH in 1 CARTON (15054-1060-4) / 1 SYRINGE in 1 POUCH / .2 mL in 1 SYRINGE	1 pouch	2019-09-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
SOMATULINE DEPOT	Ipsen Biopharmaceuticals, Inc. \| IPSEN PHARMA BIOTECH	2024-10-11	HUMAN PRESCRIPTION DRUG LABEL	16