VIVITROL

Product NDC: 65757-300
11-digit product format: 657570300
Labeler code: 65757
Product ID: 65757-300_0f2da087-0d96-4978-9291-4ddf836fb7e5
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: naltrexone
Dosage form: KIT
Labeler: Alkermes, Inc.
Application: NDA021897
Marketing category: NDA
Marketing start: 2006-06-13
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 42.

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
N021897-001	VIVITROL	NALTREXONE	380MG/VIAL	FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR		RLD, RS	2006-04-13

Orange Book patents#

Current patent rows page 1 of 1 · 2 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N021897-001	7919499	2029-10-15	U-1123		2011-05-16
N021897-001	7919499	2029-10-15	U-1124		2011-05-16

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 · 42 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
2026-08-18 06:07:40	2026-07	N021897-001	VIVITROL	380MG/VIAL	FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR		RLD, RS	2006-04-13	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021897-001	VIVITROL	380MG/VIAL	FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR		RLD, RS	2006-04-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021897-001	VIVITROL	380MG/VIAL	FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR		RLD, RS	2006-04-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021897-001	VIVITROL	380MG/VIAL	FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR		RLD, RS	2006-04-13	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021897-001	VIVITROL	380MG/VIAL	FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR		RLD, RS	2006-04-13	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021897-001	VIVITROL	380MG/VIAL	FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR		RLD, RS	2006-04-13	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021897-001	VIVITROL	380MG/VIAL	FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR		RLD, RS	2006-04-13	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021897-001	VIVITROL	380MG/VIAL	FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR		RLD, RS	2006-04-13	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021897-001	VIVITROL	380MG/VIAL	FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR		RLD, RS	2006-04-13	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021897-001	VIVITROL	380MG/VIAL	FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR		RLD, RS	2006-04-13	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021897-001	VIVITROL	380MG/VIAL	FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR		RLD, RS	2006-04-13	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021897-001	VIVITROL	380MG/VIAL	FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR		RLD, RS	2006-04-13	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021897-001	VIVITROL	380MG/VIAL	FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR		RLD, RS	2006-04-13	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021897-001	VIVITROL	380MG/VIAL	FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR		RLD, RS	2006-04-13	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021897-001	VIVITROL	380MG/VIAL	FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR		RLD, RS	2006-04-13	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021897-001	VIVITROL	380MG/VIAL	FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR		RLD, RS	2006-04-13	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021897-001	VIVITROL	380MG/VIAL	FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR		RLD, RS	2006-04-13	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021897-001	VIVITROL	380MG/VIAL	FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR		RLD, RS	2006-04-13	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021897-001	VIVITROL	380MG/VIAL	FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR		RLD, RS	2006-04-13	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021897-001	VIVITROL	380MG/VIAL	FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR		RLD, RS	2006-04-13	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021897-001	VIVITROL	380MG/VIAL	FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR		RLD, RS	2006-04-13	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021897-001	VIVITROL	380MG/VIAL	FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR		RLD, RS	2006-04-13	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021897-001	VIVITROL	380MG/VIAL	FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR		RLD, RS	2006-04-13	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021897-001	VIVITROL	380MG/VIAL	FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR		RLD, RS	2006-04-13	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021897-001	VIVITROL	380MG/VIAL	FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR		RLD, RS	2006-04-13	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021897-001	VIVITROL	380MG/VIAL	FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR		RLD, RS	2006-04-13	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021897-001	VIVITROL	380MG/VIAL	FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR		RLD, RS	2006-04-13	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021897-001	VIVITROL	380MG/VIAL	FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR		RLD, RS	2006-04-13	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021897-001	VIVITROL	380MG/VIAL	FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR		RLD, RS	2006-04-13	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N021897-001	VIVITROL	380MG/VIAL	FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR		RLD, RS	2006-04-13	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N021897-001	VIVITROL	380MG/VIAL	FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	AP	RLD, RS	2006-04-13	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021897-001	VIVITROL	380MG/VIAL	FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	AP	RLD, RS	2006-04-13	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021897-001	VIVITROL	380MG/VIAL	FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	AP	RLD, RS	2006-04-13	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021897-001	VIVITROL	380MG/VIAL	FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	AP	RLD, RS	2006-04-13	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021897-001	VIVITROL	380MG/VIAL	FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR		RLD, RS	2006-04-13	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N021897-001	VIVITROL	380MG/VIAL	FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR		RLD, RS	2006-04-13	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N021897-001	VIVITROL	380MG/VIAL	FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR		RLD, RS	2006-04-13	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021897-001	VIVITROL	380MG/VIAL	FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR		RLD, RS	2006-04-13	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N021897-001	VIVITROL	380MG/VIAL	FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR		RLD, RS	2006-04-13	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N021897-001	VIVITROL	380MG/VIAL	FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR		RLD, RS	2006-04-13	`e64feba35796…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2023-12-20 04:57 UTC	2023-12	N021897-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021897-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021897-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021897-001	AP	1	`a67488948f0b…`

Observed Orange Book patent history#

Patent history page 1 of 4 · 144 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-08-18 06:07:40	2026-07	N021897-001	7919499	2029-10-15	U-1124		2011-05-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021897-001	7919499	2029-10-15	U-1123		2011-05-16	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021897-001	7919499	2029-10-15	U-1124		2011-05-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021897-001	7919499	2029-10-15	U-1123		2011-05-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021897-001	7919499	2029-10-15	U-1124		2011-05-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021897-001	7919499	2029-10-15	U-1123		2011-05-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021897-001	7919499	2029-10-15	U-1124		2011-05-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021897-001	7919499	2029-10-15	U-1123		2011-05-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021897-001	7919499	2029-10-15	U-1124		2011-05-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021897-001	7919499	2029-10-15	U-1123		2011-05-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021897-001	7919499	2029-10-15	U-1124		2011-05-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021897-001	7919499	2029-10-15	U-1123		2011-05-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021897-001	7919499	2029-10-15	U-1124		2011-05-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021897-001	7919499	2029-10-15	U-1123		2011-05-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021897-001	7919499	2029-10-15	U-1124		2011-05-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021897-001	7919499	2029-10-15	U-1123		2011-05-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021897-001	7919499	2029-10-15	U-1124		2011-05-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021897-001	7919499	2029-10-15	U-1123		2011-05-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021897-001	7919499	2029-10-15	U-1124		2011-05-16	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021897-001	7919499	2029-10-15	U-1123		2011-05-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021897-001	7919499	2029-10-15	U-1124		2011-05-16	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021897-001	7919499	2029-10-15	U-1123		2011-05-16	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021897-001	7919499	2029-10-15	U-1124		2011-05-16	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021897-001	7919499	2029-10-15	U-1123		2011-05-16	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021897-001	7919499	2029-10-15	U-1124		2011-05-16	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021897-001	7919499	2029-10-15	U-1123		2011-05-16	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021897-001	7919499	2029-10-15	U-1124		2011-05-16	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021897-001	7919499	2029-10-15	U-1123		2011-05-16	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021897-001	7919499	2029-10-15	U-1124		2011-05-16	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N021897-001	7919499	2029-10-15	U-1123		2011-05-16	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021897-001	7919499	2029-10-15	U-1124		2011-05-16	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021897-001	7919499	2029-10-15	U-1123		2011-05-16	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021897-001	7919499	2029-10-15	U-1124		2011-05-16	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021897-001	7919499	2029-10-15	U-1123		2011-05-16	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021897-001	7919499	2029-10-15	U-1124		2011-05-16	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021897-001	7919499	2029-10-15	U-1123		2011-05-16	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021897-001	6331317	2019-11-12		Drug product		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021897-001	6395304	2019-11-12		Drug product		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021897-001	6495166	2019-11-12		Drug product		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021897-001	6537586	2019-11-12		Drug product		`74a2ff9319b5…`

Additional Listing Data#

Finished product: Yes
Brand name base: VIVITROL
Listing expiration: 2027-12-31

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
637213	Internal RxNorm lookup
637216	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
cd11c435-b0f0-4bb9-ae78-60f101f3703f	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
31849934-38d8-47fe-b84a-4d392838c14b	Product name	1	20170823
8e48b6b8-3a2f-4e0d-b7c9-38d70393b778	Product name	1	20161103
e4d463bc-c674-43cb-be06-82786f310d01	Product name	1	20150326
7a537f54-d322-5e54-a3a2-035d3e21c3c6	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
65757-300-01	VIVITROL	1 in 1 CARTON	KIT	1		38
65757-302-02	VIVITROL	4 mL in 1 VIAL, GLASS	INJECTION, POWDER, FOR SUSPENSIO	4 mL	380 mg in 4mL	38

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
65757-300-01	EA - Each	65757-300	542a7737-8e23-43dc-80d1-534a594bde23	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version	Uploaded
naltrexone	ACTIVE INGREDIENT	5S6W795CQM	VIVITROL (NALTREXONE) KIT [ALKERMES, INC.]	14
naltrexone	ACTIVE MOIETY	5S6W795CQM	VIVITROL (NALTREXONE) KIT [ALKERMES, INC.]	14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
65757-300	VIVITROL (NALTREXONE) KIT [ALKERMES, INC.]	36	Current NDC, Legacy NDC, 2 package rows	20240608_cd11c435-b0f0-4bb9-ae78-60f101f3703f.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
VIVITROL	NALTREXONE	Alkermes, Inc.	cd11c435-b0f0-4bb9-ae78-60f101f3703f	2026-05-31	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021897 application number: NDA021897 ndc (product): 65757-300
Naltrexone	NALTREXONE	Amneal Pharmaceuticals NY LLC	6de5637f-d527-4228-af1a-3aae71155cb5	2026-01-30	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021897 application number: NDA021897

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
5S6W795CQM	NALTREXONE	16590-41-3	naltrexone

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
637213	naltrexone 380 MG Injection	PSN	cd11c435-b0f0-4bb9-ae78-60f101f3703f	38
637216	Vivitrol 380 MG Injection	PSN	cd11c435-b0f0-4bb9-ae78-60f101f3703f	38
637216	naltrexone 380 MG Injection [Vivitrol]	SBD	cd11c435-b0f0-4bb9-ae78-60f101f3703f	38
637213	naltrexone 380 MG Injection	SCD	cd11c435-b0f0-4bb9-ae78-60f101f3703f	38
637216	Vivitrol 380 MG Injection	SY	cd11c435-b0f0-4bb9-ae78-60f101f3703f	38

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
65757-300-01	65757030001	1 KIT in 1 CARTON (65757-300-01) * 4 mL in 1 VIAL, GLASS (65757-302-02) * 4 mL in 1 VIAL, GLASS (65757-304-03)	1 kit	2006-06-13	0000-00-00	No	No	Current
65757-302-02	65757030202	4 mL in 1 VIAL, GLASS	4 ml					Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
VIVITROL	Alkermes, Inc. \| Packaging Coordinators, LLC \| Sharp Corporation	2026-05-31	HUMAN PRESCRIPTION DRUG LABEL	39