NALTREXONE HYDROCHLORIDE

Product NDC: 47335-326
11-digit product format: 473350326
Labeler code: 47335
Product ID: 47335-326_b0c2b60a-dc96-483b-933e-2fed58b64372
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: NALTREXONE HYDROCHLORIDE
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Sun Pharmaceutical Industries, Inc.
Application: ANDA090356
Marketing category: ANDA
Marketing start: 2012-02-29
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 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
A090356-001	NALTREXONE HYDROCHLORIDE	NALTREXONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB		2012-02-24

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A090356-001	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 · 42 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
2026-08-18 06:07:40	2026-07	A090356-001	NALTREXONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2012-02-24	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090356-001	NALTREXONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2012-02-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090356-001	NALTREXONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2012-02-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090356-001	NALTREXONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2012-02-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090356-001	NALTREXONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2012-02-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090356-001	NALTREXONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2012-02-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090356-001	NALTREXONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2012-02-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090356-001	NALTREXONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2012-02-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090356-001	NALTREXONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2012-02-24	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090356-001	NALTREXONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2012-02-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090356-001	NALTREXONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2012-02-24	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090356-001	NALTREXONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2012-02-24	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090356-001	NALTREXONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2012-02-24	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090356-001	NALTREXONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2012-02-24	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090356-001	NALTREXONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2012-02-24	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090356-001	NALTREXONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2012-02-24	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090356-001	NALTREXONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2012-02-24	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090356-001	NALTREXONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2012-02-24	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090356-001	NALTREXONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2012-02-24	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090356-001	NALTREXONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2012-02-24	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090356-001	NALTREXONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2012-02-24	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090356-001	NALTREXONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2012-02-24	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A090356-001	NALTREXONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2012-02-24	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A090356-001	NALTREXONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2012-02-24	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A090356-001	NALTREXONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2012-02-24	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A090356-001	NALTREXONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2012-02-24	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A090356-001	NALTREXONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2012-02-24	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A090356-001	NALTREXONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2012-02-24	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A090356-001	NALTREXONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2012-02-24	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A090356-001	NALTREXONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2012-02-24	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A090356-001	NALTREXONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2012-02-24	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A090356-001	NALTREXONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2012-02-24	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A090356-001	NALTREXONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2012-02-24	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A090356-001	NALTREXONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2012-02-24	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A090356-001	NALTREXONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2012-02-24	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A090356-001	NALTREXONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2012-02-24	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A090356-001	NALTREXONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2012-02-24	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A090356-001	NALTREXONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2012-02-24	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A090356-001	NALTREXONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2012-02-24	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A090356-001	NALTREXONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2012-02-24	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A090356-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090356-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090356-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090356-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090356-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090356-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090356-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090356-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090356-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090356-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090356-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090356-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090356-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090356-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090356-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090356-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090356-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090356-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090356-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090356-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090356-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090356-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A090356-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A090356-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A090356-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A090356-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A090356-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A090356-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A090356-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A090356-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A090356-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A090356-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A090356-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A090356-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A090356-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A090356-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A090356-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A090356-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A090356-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A090356-001	AB	1	`e64feba35796…`

Additional Listing Data#

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

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
0f30f885-d0cd-4fa6-a8e0-142f08a56792	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	SPL version
47335-326-08	NALTREXONE HYDROCHLORIDE	100 in 1 BOTTLE	TABLET, FILM COATED	100	7
47335-326-18	NALTREXONE HYDROCHLORIDE	1000 in 1 BOTTLE	TABLET, FILM COATED	1000	7
47335-326-83	NALTREXONE HYDROCHLORIDE	30 in 1 BOTTLE	TABLET, FILM COATED	30	7
47335-326-88	NALTREXONE HYDROCHLORIDE	100 in 1 BOTTLE	TABLET, FILM COATED	100	7

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
47335-326-83	EA - Each	47335-326	7603c646-e6c1-4137-b42d-2eac9c1b68db	1	2012-07-24
47335-326-88	EA - Each	47335-326	69d3cb95-b00b-4cd7-9483-948069af4c96	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
NALTREXONE HYDROCHLORIDE	ACTIVE INGREDIENT	Z6375YW9SF	NALTREXONE HYDROCHLORIDE TABLET, FILM COATED [SUN PHARMA GLOBAL FZE]	5
NALTREXONE	ACTIVE MOIETY	5S6W795CQM	NALTREXONE HYDROCHLORIDE TABLET, FILM COATED [SUN PHARMA GLOBAL FZE]	5
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	NALTREXONE HYDROCHLORIDE TABLET, FILM COATED [SUN PHARMA GLOBAL FZE]	5
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	NALTREXONE HYDROCHLORIDE TABLET, FILM COATED [SUN PHARMA GLOBAL FZE]	5
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	NALTREXONE HYDROCHLORIDE TABLET, FILM COATED [SUN PHARMA GLOBAL FZE]	5
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	NALTREXONE HYDROCHLORIDE TABLET, FILM COATED [SUN PHARMA GLOBAL FZE]	5
HYPROMELLOSE 2910 (6 MPA.S)	INACTIVE INGREDIENT	0WZ8WG20P6	NALTREXONE HYDROCHLORIDE TABLET, FILM COATED [SUN PHARMA GLOBAL FZE]	5
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	NALTREXONE HYDROCHLORIDE TABLET, FILM COATED [SUN PHARMA GLOBAL FZE]	5
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	NALTREXONE HYDROCHLORIDE TABLET, FILM COATED [SUN PHARMA GLOBAL FZE]	5
POLYETHYLENE GLYCOL 400	INACTIVE INGREDIENT	B697894SGQ	NALTREXONE HYDROCHLORIDE TABLET, FILM COATED [SUN PHARMA GLOBAL FZE]	5
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	NALTREXONE HYDROCHLORIDE TABLET, FILM COATED [SUN PHARMA GLOBAL FZE]	5
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	NALTREXONE HYDROCHLORIDE TABLET, FILM COATED [SUN PHARMA GLOBAL FZE]	5
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	NALTREXONE HYDROCHLORIDE TABLET, FILM COATED [SUN PHARMA GLOBAL FZE]	5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
47335-326	NALTREXONE HYDROCHLORIDE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES, INC.]	7	Current NDC, Legacy NDC, 4 package rows	20231026_0f30f885-d0cd-4fa6-a8e0-142f08a56792.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 · 7 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
NALTREXONE HYDROCHLORIDE	NALTREXONE HYDROCHLORIDE	REMEDYREPACK INC.	f821dd49-3fa7-4d33-99de-19023ff1ae65	2026-07-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090356 application number: ANDA090356
NALTREXONE HYDROCHLORIDE	NALTREXONE HYDROCHLORIDE	Bryant Ranch Prepack	f9807ec0-3504-4c66-8efe-ea25f84c782b	2026-07-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090356 application number: ANDA090356
NALTREXONE HYDROCHLORIDE	NALTREXONE HYDROCHLORIDE	Major Pharmaceuticals	69cb8573-08c1-4957-a768-6cd383f6a3f4	2026-06-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090356 application number: ANDA090356
NALTREXONE HYDROCHLORIDE	NALTREXONE HYDROCHLORIDE	Coupler LLC	544f79a7-ca89-795d-e063-6294a90a8a97	2026-06-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090356 application number: ANDA090356
NALTREXONE HYDROCHLORIDE	NALTREXONE HYDROCHLORIDE	Sun Pharmaceutical Industries, Inc.	0f30f885-d0cd-4fa6-a8e0-142f08a56792	2026-06-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090356 application number: ANDA090356 ndc (product): 47335-326
NALTREXONE HYDROCHLORIDE	NALTREXONE HYDROCHLORIDE	NCS HealthCare of KY, LLC dba Vangard Labs	fa2f842f-001a-4f1e-8748-c7852579109c	2025-09-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090356 application number: ANDA090356
NALTREXONE HYDROCHLORIDE	NALTREXONE HYDROCHLORIDE	Proficient Rx LP	f3305f0b-fb9e-4009-b28f-47fe9b1b618b	2025-02-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090356 application number: ANDA090356

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	f9807ec0-3504-4c66-8efe-ea25f84c782b	101
1483744	naltrexone hydrochloride 50 MG Oral Tablet	SCD	f9807ec0-3504-4c66-8efe-ea25f84c782b	101
1483744	naltrexone HCl 50 MG Oral Tablet	PSN	f821dd49-3fa7-4d33-99de-19023ff1ae65	8
1483744	naltrexone hydrochloride 50 MG Oral Tablet	SCD	f821dd49-3fa7-4d33-99de-19023ff1ae65	8
1483744	naltrexone HCl 50 MG Oral Tablet	PSN	0f30f885-d0cd-4fa6-a8e0-142f08a56792	7
1483744	naltrexone hydrochloride 50 MG Oral Tablet	SCD	0f30f885-d0cd-4fa6-a8e0-142f08a56792	7
1483744	naltrexone HCl 50 MG Oral Tablet	PSN	69cb8573-08c1-4957-a768-6cd383f6a3f4	5
1483744	naltrexone hydrochloride 50 MG Oral Tablet	SCD	69cb8573-08c1-4957-a768-6cd383f6a3f4	5
1483744	naltrexone HCl 50 MG Oral Tablet	PSN	e71de213-5250-4a63-9ef7-9ef2f9954d8b	4
1483744	naltrexone hydrochloride 50 MG Oral Tablet	SCD	e71de213-5250-4a63-9ef7-9ef2f9954d8b	4
1483744	naltrexone HCl 50 MG Oral Tablet	PSN	f3305f0b-fb9e-4009-b28f-47fe9b1b618b	1
1483744	naltrexone HCl 50 MG Oral Tablet	PSN	fa2f842f-001a-4f1e-8748-c7852579109c	1
1483744	naltrexone hydrochloride 50 MG Oral Tablet	SCD	f3305f0b-fb9e-4009-b28f-47fe9b1b618b	1
1483744	naltrexone hydrochloride 50 MG Oral Tablet	SCD	fa2f842f-001a-4f1e-8748-c7852579109c	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
47335-326-08	47335032608	100 TABLET, FILM COATED in 1 BOTTLE (47335-326-08)	2012-02-29	0000-00-00	No	No	Current
47335-326-18	47335032618	1000 TABLET, FILM COATED in 1 BOTTLE (47335-326-18)	2012-02-29	0000-00-00	No	No	Current
47335-326-83	47335032683	30 TABLET, FILM COATED in 1 BOTTLE (47335-326-83)	2012-02-29	0000-00-00	No	No	Current
47335-326-88	47335032688	100 TABLET, FILM COATED in 1 BOTTLE (47335-326-88)	2012-02-29	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Naltrexone Hydrochloride Tablets, USP Opioid Antagonist	REMEDYREPACK INC.	2026-07-28	HUMAN PRESCRIPTION DRUG LABEL	9
Naltrexone Hydrochloride Tablets, USP Opioid Antagonist	Bryant Ranch Prepack	2026-07-15	HUMAN PRESCRIPTION DRUG LABEL	102
Naltrexone Hydrochloride Tablets, USP Opioid Antagonist	Major Pharmaceuticals	2026-06-24	HUMAN PRESCRIPTION DRUG LABEL	6
Naltrexone Hydrochloride Tablets, USP Opioid Antagonist	Coupler LLC	2026-06-15	HUMAN PRESCRIPTION DRUG LABEL	1
Naltrexone Hydrochloride Tablets, USP Opioid Antagonist	Sun Pharmaceutical Industries, Inc. \| Sun Pharmaceutical Industries Limited	2026-06-04	HUMAN PRESCRIPTION DRUG LABEL	8
Naltrexone Hydrochloride Tablets, USP Opioid Antagonist	NCS HealthCare of KY, LLC dba Vangard Labs	2025-09-03	HUMAN PRESCRIPTION DRUG LABEL	1
Naltrexone Hydrochloride Tablets, USP Opioid Antagonist	Proficient Rx LP	2025-02-01	HUMAN PRESCRIPTION DRUG LABEL	1
Naltrexone Hydrochloride Tablets, USP Opioid Antagonist	A-S Medication Solutions	2020-01-18	Human Prescription Drug Label	4