LUTRATE DEPOT

Product NDC: 83831-134
11-digit product format: 838310134
Labeler code: 83831
Product ID: 83831-134_d4332d30-8a83-4118-88bb-3c49851837b6
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: leuprolide acetate
Dosage form: KIT
Labeler: Avyxa Pharma, LLC
Application: NDA205054
Marketing category: NDA
Marketing start: 2025-03-26
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 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N205054-001	LEUPROLIDE ACETATE FOR DEPOT SUSPENSION	LEUPROLIDE ACETATE	22.5MG/VIAL	FOR SUSPENSION / INTRAMUSCULAR		RLD, RS	2018-08-28

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 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N205054-001	LEUPROLIDE ACETATE FOR DEPOT SUSPENSION	22.5MG/VIAL	FOR SUSPENSION / INTRAMUSCULAR	RLD, RS	2018-08-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205054-001	LEUPROLIDE ACETATE FOR DEPOT SUSPENSION	22.5MG/VIAL	FOR SUSPENSION / INTRAMUSCULAR	RLD, RS	2018-08-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N205054-001	LEUPROLIDE ACETATE FOR DEPOT SUSPENSION	22.5MG/VIAL	FOR SUSPENSION / INTRAMUSCULAR	RLD, RS	2018-08-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N205054-001	LEUPROLIDE ACETATE FOR DEPOT SUSPENSION	22.5MG/VIAL	FOR SUSPENSION / INTRAMUSCULAR	RLD, RS	2018-08-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N205054-001	LEUPROLIDE ACETATE FOR DEPOT SUSPENSION	22.5MG/VIAL	FOR SUSPENSION / INTRAMUSCULAR	RLD, RS	2018-08-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N205054-001	LEUPROLIDE ACETATE FOR DEPOT SUSPENSION	22.5MG/VIAL	FOR SUSPENSION / INTRAMUSCULAR	RLD, RS	2018-08-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N205054-001	LEUPROLIDE ACETATE FOR DEPOT SUSPENSION	22.5MG/VIAL	FOR SUSPENSION / INTRAMUSCULAR	RLD, RS	2018-08-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N205054-001	LEUPROLIDE ACETATE FOR DEPOT SUSPENSION	22.5MG/VIAL	FOR SUSPENSION / INTRAMUSCULAR	RLD, RS	2018-08-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N205054-001	LEUPROLIDE ACETATE FOR DEPOT SUSPENSION	22.5MG/VIAL	FOR SUSPENSION / INTRAMUSCULAR	RLD, RS	2018-08-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N205054-001	LEUPROLIDE ACETATE FOR DEPOT SUSPENSION	22.5MG/VIAL	FOR SUSPENSION / INTRAMUSCULAR	RLD, RS	2018-08-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N205054-001	LEUPROLIDE ACETATE FOR DEPOT SUSPENSION	22.5MG/VIAL	FOR SUSPENSION / INTRAMUSCULAR	RLD, RS	2018-08-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N205054-001	LEUPROLIDE ACETATE FOR DEPOT SUSPENSION	22.5MG/VIAL	FOR SUSPENSION / INTRAMUSCULAR	RLD, RS	2018-08-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N205054-001	LEUPROLIDE ACETATE FOR DEPOT SUSPENSION	22.5MG/VIAL	FOR SUSPENSION / INTRAMUSCULAR	RLD, RS	2018-08-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N205054-001	LEUPROLIDE ACETATE FOR DEPOT SUSPENSION	22.5MG/VIAL	FOR SUSPENSION / INTRAMUSCULAR	RLD, RS	2018-08-28	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N205054-001	LUTRATE DEPOT KIT	22.5MG/VIAL	FOR SUSPENSION / INTRAMUSCULAR	RLD, RS	2018-08-28	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N205054-001	LUTRATE DEPOT KIT	22.5MG/VIAL	FOR SUSPENSION / INTRAMUSCULAR	RLD	2018-08-28	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N205054-001	LUTRATE DEPOT KIT	22.5MG/VIAL	FOR SUSPENSION / INTRAMUSCULAR	RLD	2018-08-28	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N205054-001	LUTRATE DEPOT KIT	22.5MG/VIAL	FOR SUSPENSION / INTRAMUSCULAR	RLD	2018-08-28	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N205054-001	LUTRATE DEPOT KIT	22.5MG/VIAL	FOR SUSPENSION / INTRAMUSCULAR	RLD	2018-08-28	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N205054-001	LUTRATE DEPOT KIT	22.5MG/VIAL	FOR SUSPENSION / INTRAMUSCULAR	RLD	2018-08-28	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N205054-001	LUTRATE DEPOT KIT	22.5MG/VIAL	FOR SUSPENSION / INTRAMUSCULAR	RLD	2018-08-28	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N205054-001	LUTRATE DEPOT KIT	22.5MG/VIAL	FOR SUSPENSION / INTRAMUSCULAR	RLD	2018-08-28	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N205054-001	LUTRATE DEPOT KIT	22.5MG/VIAL	FOR SUSPENSION / INTRAMUSCULAR	RLD	2018-08-28	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N205054-001	LUTRATE DEPOT KIT	22.5MG/VIAL	FOR SUSPENSION / INTRAMUSCULAR	RLD	2018-08-28	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N205054-001	LUTRATE DEPOT KIT	22.5MG/VIAL	FOR SUSPENSION / INTRAMUSCULAR	RLD	2018-08-28	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N205054-001	LUTRATE DEPOT KIT	22.5MG/VIAL	FOR SUSPENSION / INTRAMUSCULAR	RLD	2018-08-28	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N205054-001	LUTRATE DEPOT KIT	22.5MG/VIAL	FOR SUSPENSION / INTRAMUSCULAR	RLD	2018-08-28	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N205054-001	LEUPROLIDE ACETATE FOR DEPOT SUSPENSION	22.5MG/VIAL	FOR SUSPENSION / INTRAMUSCULAR	RLD, RS	2018-08-28	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N205054-001	LEUPROLIDE ACETATE FOR DEPOT SUSPENSION	22.5MG/VIAL	FOR SUSPENSION / INTRAMUSCULAR	RLD, RS	2018-08-28	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N205054-001	LUTRATE DEPOT KIT	22.5MG/VIAL	FOR SUSPENSION / INTRAMUSCULAR	RLD, RS	2018-08-28	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N205054-001	LUTRATE DEPOT KIT	22.5MG/VIAL	FOR SUSPENSION / INTRAMUSCULAR	RLD, RS	2018-08-28	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N205054-001	LUTRATE DEPOT KIT	22.5MG/VIAL	FOR SUSPENSION / INTRAMUSCULAR	RLD, RS	2018-08-28	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N205054-001	LUTRATE DEPOT KIT	22.5MG/VIAL	FOR SUSPENSION / INTRAMUSCULAR	RLD, RS	2018-08-28	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N205054-001	LUTRATE DEPOT KIT	22.5MG/VIAL	FOR SUSPENSION / INTRAMUSCULAR	RLD, RS	2018-08-28	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N205054-001	LUTRATE DEPOT KIT	22.5MG/VIAL	FOR SUSPENSION / INTRAMUSCULAR	RLD, RS	2018-08-28	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N205054-001	LUTRATE DEPOT KIT	22.5MG/VIAL	FOR SUSPENSION / INTRAMUSCULAR	RLD, RS	2018-08-28	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N205054-001	LUTRATE DEPOT KIT	22.5MG/VIAL	FOR SUSPENSION / INTRAMUSCULAR	RLD, RS	2018-08-28	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N205054-001	LUTRATE DEPOT KIT	22.5MG/VIAL	FOR SUSPENSION / INTRAMUSCULAR	RLD, RS	2018-08-28	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N205054-001	LUTRATE DEPOT KIT	22.5MG/VIAL	FOR SUSPENSION / INTRAMUSCULAR	RLD, RS	2018-08-28	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N205054-001	LUTRATE DEPOT KIT	22.5MG/VIAL	FOR SUSPENSION / INTRAMUSCULAR	RLD, RS	2018-08-28	`cb3db0bc1861…`

Observed Orange Book patent history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Coverage / status	Submission date	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N205054-001	9789064	2020-12-15	Drug product	2018-09-26	`74a2ff9319b5…`
2020-12-22 03:56 UTC	2020-12	N205054-001	9789064	2020-12-15	Drug product	2018-09-26	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N205054-001	9789064	2020-12-15	Drug product	2018-09-26	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N205054-001	9789064	2020-12-15	Drug product	2018-09-26	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N205054-001	9789064	2020-12-15	Drug product	2018-09-26	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N205054-001	9789064	2020-12-15	Drug product	2018-09-26	`ea99ee380514…`

Additional Listing Data#

Finished product: Yes
Brand name base: LUTRATE DEPOT
Listing expiration: 2026-12-31

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
2606516	Internal RxNorm lookup
2709448	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
3a6d1373-17d9-4289-b62f-d299ffe55831	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
9e666f57-491f-16e0-fc75-cc1c9f2fe06f	Product name	4	20250515
43944b95-6cc2-4eca-846a-a5e0ed070616	Product name	1	20240501
f3ff4518-37fe-47a0-8a1e-6ce032a3efd5	Product name	1	20230829
2ed2d111-4d16-4e2a-9b09-7d196056f6c9	Product name	1	20211214
a62a50ac-1535-4461-9768-8ae703e2e9fb	Product name	1	20210525
ce98e98f-fa6b-48a6-8ad2-9ef8e8098f26	Product name	1	20200925
23ede539-308f-46e5-817b-41ef23af8d40	Product name	1	20150930
425e3610-bbe8-4d70-9c46-8cf09afc4e4d	Product name	1	20150930
ae18ed71-8057-40ec-987f-83624e50b906	Product name	1	20150122
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877	Product name	1	20140508
bc07ef78-e82d-0c19-31f4-31f263780582	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
83831-134-01	LUTRATE DEPOT	1 in 1 CARTON	KIT	1		2
83831-150-22	LUTRATE DEPOT	2 mL in 1 VIAL, SINGLE-DOSE	INJECTION, POWDER, LYOPHILIZED,	2 mL	22.5 mg in 2mL	2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
83831-134-01	EA - Each	83831-134	dac658a3-b240-4830-af77-1d8237a3839b	1	2025-05-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
83831-134	LUTRATE DEPOT (LEUPROLIDE ACETATE) KIT [AVYXA PHARMA, LLC]	1	Current NDC, 2 package rows	20250330_3a6d1373-17d9-4289-b62f-d299ffe55831.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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
LUTRATE DEPOT	LEUPROLIDE ACETATE	Avyxa Pharma, LLC	3a6d1373-17d9-4289-b62f-d299ffe55831	2025-06-03	Warnings, Adverse reactions	Exact identifier application applno (NDA): 205054 application number: NDA205054 ndc (product): 83831-134
LEUPROLIDE ACETATE DEPOT	LEUPROLIDE ACETATE	CIPLA USA INC.	1563a30b-66e0-445d-ba3e-1ccd5218133f	2024-08-27	Warnings, Adverse reactions	Exact identifier application applno (NDA): 205054 application number: NDA205054

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
37JNS02E7V	LEUPROLIDE ACETATE	74381-53-6	leuprolide acetate

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2606516	leuprolide acetate 22.5 MG Injection	PSN	3a6d1373-17d9-4289-b62f-d299ffe55831	2
2709448	Lutrate Depot 22.5 MG Injection	PSN	3a6d1373-17d9-4289-b62f-d299ffe55831	2
2709448	leuprolide acetate 22.5 MG Injection [Lutrate]	SBD	3a6d1373-17d9-4289-b62f-d299ffe55831	2
2606516	leuprolide acetate 22.5 MG Injection	SCD	3a6d1373-17d9-4289-b62f-d299ffe55831	2
2709448	Lutrate Depot 22.5 MG Injection	SY	3a6d1373-17d9-4289-b62f-d299ffe55831	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
83831-134-01	83831013401	1 KIT in 1 CARTON (83831-134-01) * 2 mL in 1 VIAL, SINGLE-DOSE (83831-150-22) * 2 mL in 1 SYRINGE (83831-135-02)	1 kit	2025-03-26	No	No	Current
83831-150-22	83831015022	2 mL in 1 VIAL, SINGLE-DOSE	2 ml				Historical