Naltrexone Hydrochloride

Product NDC: 68071-3654
Requested package NDC: 68071-3654-3
11-digit product format: 680713654
Labeler code: 68071
Product ID: 68071-3654_2a2ff668-e2bb-5308-e063-6294a90a832d
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Naltrexone Hydrochloride
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: NuCare Pharmaceuticals Inc.
Application: ANDA075274
Marketing category: ANDA
Marketing start: 2024-02-15
Substance: NALTREXONE HYDROCHLORIDE
Active strength: 50 mg/1
Pharmacologic classes: Opioid Antagonist [EPC], Opioid Antagonists [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 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
A075274-001	NALTREXONE HYDROCHLORIDE	NALTREXONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB		1999-05-26

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A075274-001	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 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A075274-001	NALTREXONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1999-05-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075274-001	NALTREXONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1999-05-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075274-001	NALTREXONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1999-05-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075274-001	NALTREXONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1999-05-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075274-001	NALTREXONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1999-05-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075274-001	NALTREXONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1999-05-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075274-001	NALTREXONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1999-05-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075274-001	NALTREXONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1999-05-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075274-001	NALTREXONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1999-05-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075274-001	NALTREXONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1999-05-26	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075274-001	NALTREXONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1999-05-26	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075274-001	NALTREXONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1999-05-26	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075274-001	NALTREXONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1999-05-26	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075274-001	NALTREXONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1999-05-26	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075274-001	NALTREXONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1999-05-26	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075274-001	NALTREXONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1999-05-26	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075274-001	NALTREXONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1999-05-26	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075274-001	NALTREXONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1999-05-26	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075274-001	NALTREXONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1999-05-26	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075274-001	NALTREXONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1999-05-26	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075274-001	NALTREXONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1999-05-26	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A075274-001	NALTREXONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1999-05-26	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A075274-001	NALTREXONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1999-05-26	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A075274-001	NALTREXONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1999-05-26	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A075274-001	NALTREXONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1999-05-26	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075274-001	NALTREXONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1999-05-26	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075274-001	NALTREXONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1999-05-26	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A075274-001	NALTREXONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1999-05-26	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A075274-001	NALTREXONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1999-05-26	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A075274-001	NALTREXONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1999-05-26	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A075274-001	NALTREXONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1999-05-26	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A075274-001	NALTREXONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1999-05-26	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A075274-001	NALTREXONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1999-05-26	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A075274-001	NALTREXONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1999-05-26	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A075274-001	NALTREXONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1999-05-26	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A075274-001	NALTREXONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1999-05-26	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A075274-001	NALTREXONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1999-05-26	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A075274-001	NALTREXONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1999-05-26	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A075274-001	NALTREXONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1999-05-26	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A075274-001	NALTREXONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1999-05-26	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A075274-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075274-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075274-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075274-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075274-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075274-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075274-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075274-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075274-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075274-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075274-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075274-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075274-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075274-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075274-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075274-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075274-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075274-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075274-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075274-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075274-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A075274-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A075274-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A075274-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A075274-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075274-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075274-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A075274-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A075274-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A075274-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A075274-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A075274-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A075274-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A075274-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A075274-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A075274-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A075274-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A075274-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A075274-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A075274-001	AB	1	`cb3db0bc1861…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 2 · 23 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Naltrexone Hydrochloride	NALTREXONE HYDROCHLORIDE	Coupler LLC	56055980-d23b-ec7d-e063-6394a90a9cc2	2026-05-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075274 application number: ANDA075274
Naltrexone Hydrochloride	NALTREXONE HYDROCHLORIDE	Elite Laboratories, Inc.	5f188bdc-2009-43aa-ad32-f06dbfac2642	2026-05-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075274 application number: ANDA075274
Naltrexone Hydrochloride	NALTREXONE HYDROCHLORIDE	Bryant Ranch Prepack	ab5b3829-96e5-4123-967a-29b41f13a4f7	2026-04-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075274 application number: ANDA075274
Naltrexone Hydrochloride	NALTREXONE HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	4f720879-1772-e734-e063-6394a90a0cf4	2026-04-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075274 application number: ANDA075274
Naltrexone Hydrochloride	NALTREXONE HYDROCHLORIDE	Bryant Ranch Prepack	d8433c5e-deb3-4f20-aaf6-9fed6bc44974	2026-03-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075274 application number: ANDA075274
Naltrexone Hydrochloride	NALTREXONE HYDROCHLORIDE	Bryant Ranch Prepack	7976b328-ad8e-4208-9f61-19cd5ab5f36b	2026-03-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075274 application number: ANDA075274
Naltrexone Hydrochloride	NALTREXONE HYDROCHLORIDE	Bryant Ranch Prepack	b773726e-1dc9-415a-81f3-32b43b61b9b1	2026-03-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075274 application number: ANDA075274
Naltrexone Hydrochloride	NALTREXONE HYDROCHLORIDE	AvKARE	21b43dab-015c-c82f-ba6e-27da0ec12fc5	2026-02-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075274 application number: ANDA075274
Naltrexone Hydrochloride	NALTREXONE HYDROCHLORIDE	Bryant Ranch Prepack	a328c3e1-9132-491d-ae5b-45fd27ca4993	2025-12-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075274 application number: ANDA075274
Naltrexone Hydrochloride	NALTREXONE HYDROCHLORIDE	Bryant Ranch Prepack	d4d0537b-113a-4e49-bb50-bf5ddafe6b7d	2025-12-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075274 application number: ANDA075274
Naltrexone Hydrochloride	NALTREXONE HYDROCHLORIDE	Bryant Ranch Prepack	8f019ac1-13a8-42f2-bdb2-8aaef5896d96	2025-11-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075274 application number: ANDA075274
Naltrexone Hydrochloride	NALTREXONE HYDROCHLORIDE	Bryant Ranch Prepack	b5d0b9d2-8d98-4800-855e-7e8054eadf68	2025-11-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075274 application number: ANDA075274
Naltrexone Hydrochloride	NALTREXONE HYDROCHLORIDE	TAGI Pharma Inc.	60276f5c-657a-4b60-bcd0-44234903d7e0	2025-11-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075274 application number: ANDA075274
Naltrexone Hydrochloride	NALTREXONE HYDROCHLORIDE	Precision Dose Inc.	b09b4b5e-795a-48e7-b7cc-2e29f41c5660	2025-11-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075274 application number: ANDA075274
Naltrexone Hydrochloride	NALTREXONE HYDROCHLORIDE	REMEDYREPACK INC.	db911559-26f5-43a0-b61f-3425176c936f	2025-10-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075274 application number: ANDA075274
Naltrexone Hydrochloride	NALTREXONE HYDROCHLORIDE	Bryant Ranch Prepack	637ed3da-476d-4f95-8bbc-f93eaa0aa57e	2025-09-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075274 application number: ANDA075274
Naltrexone Hydrochloride	NALTREXONE HYDROCHLORIDE	Bryant Ranch Prepack	68cb0399-ca56-4310-8531-6b5552b71b25	2025-07-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075274 application number: ANDA075274
Naltrexone Hydrochloride	NALTREXONE HYDROCHLORIDE	Bryant Ranch Prepack	d7ba0156-6222-4619-a043-b5a1342d5375	2025-07-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075274 application number: ANDA075274
Naltrexone Hydrochloride	NALTREXONE HYDROCHLORIDE	Precision Dose Inc.	74087d2f-468d-4de1-a2fc-a489d0f2abef	2025-07-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075274 application number: ANDA075274
Naltrexone Hydrochloride	NALTREXONE HYDROCHLORIDE	NuCare Pharmaceuticals Inc.	1e059495-5e64-0cb0-e063-6394a90a3ffc	2024-12-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075274 application number: ANDA075274 ndc (package): 68071-3654-3 ndc (product): 68071-3654 ndc11 (package): 68071365403

Additional Listing Data#

Finished product: Yes
Brand name base: Naltrexone Hydrochloride
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
NALTREXONE HYDROCHLORIDE	50 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
Z6375YW9SF	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1483744	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
1e059495-5e64-0cb0-e063-6394a90a3ffc	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
68071-3654-3	Naltrexone Hydrochloride	30 in 1 BOTTLE	TABLET, FILM COATED	30		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68071-3654	NALTREXONE HYDROCHLORIDE TABLET, FILM COATED [NUCARE PHARMACEUTICALS INC.]	2	Current NDC, 1 package rows	20241228_1e059495-5e64-0cb0-e063-6394a90a3ffc.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
Z6375YW9SF	NALTREXONE HYDROCHLORIDE	16676-29-2	NALTREXONE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1483744	naltrexone HCl 50 MG Oral Tablet	PSN	1e059495-5e64-0cb0-e063-6394a90a3ffc	2
1483744	naltrexone hydrochloride 50 MG Oral Tablet	SCD	1e059495-5e64-0cb0-e063-6394a90a3ffc	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
68071-3654-3	68071365403	30 TABLET, FILM COATED in 1 BOTTLE (68071-3654-3)	2024-07-24	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Naltrexone Hydrochloride Tablets, USP	NuCare Pharmaceuticals Inc.	2024-12-26	HUMAN PRESCRIPTION DRUG LABEL	2