NALTREXONE HYDROCHLORIDE

Product NDC: 0406-1170
11-digit product format: 004061170
Labeler code: 0406
Product ID: 0406-1170_9ed13551-325e-4b82-a266-72fc89ed27dc
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: naltrexone hydrochloride
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: SpecGx LLC
Application: ANDA076264
Marketing category: ANDA
Marketing start: 2002-03-22
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 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A076264-001	NALTREXONE HYDROCHLORIDE	NALTREXONE HYDROCHLORIDE	25MG	TABLET / ORAL			2002-03-22
A076264-002	NALTREXONE HYDROCHLORIDE	NALTREXONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	RS	2002-03-22
A076264-003	NALTREXONE HYDROCHLORIDE	NALTREXONE HYDROCHLORIDE	100MG	TABLET / ORAL			2002-03-22

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A076264-002	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.

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
2026-08-01 22:54:32	2026-06	A076264-001	NALTREXONE HYDROCHLORIDE	25MG	TABLET / ORAL			2002-03-22	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A076264-002	NALTREXONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	RS	2002-03-22	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A076264-003	NALTREXONE HYDROCHLORIDE	100MG	TABLET / ORAL			2002-03-22	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-01 22:54:32	2026-06	A076264-002	AB	1	`a50c72e98297…`

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 1 · 8 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
NALTREXONE HYDROCHLORIDE	NALTREXONE HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	43cd6961-4793-85ee-e063-6294a90ad772	2025-11-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076264 application number: ANDA076264
NALTREXONE HYDROCHLORIDE	NALTREXONE HYDROCHLORIDE	A-S Medication Solutions	0103a32b-14a9-48a8-8952-b2b12ef09649	2025-11-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076264 application number: ANDA076264
NALTREXONE HYDROCHLORIDE	NALTREXONE HYDROCHLORIDE	Golden State Medical Supply, Inc.	3cbd0cad-7c56-ac0a-e063-6294a90a80e4	2025-08-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076264 application number: ANDA076264
NALTREXONE HYDROCHLORIDE	NALTREXONE HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	390bff41-7bab-b72a-e063-6294a90ad35d	2025-07-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076264 application number: ANDA076264
NALTREXONE HYDROCHLORIDE	NALTREXONE HYDROCHLORIDE	American Health Packaging	81e25c6a-81b6-4cfb-91bf-be20c3ae546b	2024-08-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076264 application number: ANDA076264
NALTREXONE HYDROCHLORIDE	NALTREXONE HYDROCHLORIDE	Bryant Ranch Prepack	838a1e88-1179-4a2a-a737-8ce008bb96a7	2024-05-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076264 application number: ANDA076264
NALTREXONE HYDROCHLORIDE	NALTREXONE HYDROCHLORIDE	SpecGx LLC	06ff2d5a-e62b-4fa4-bbdb-01938535bc65	2023-12-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076264 application number: ANDA076264 ndc (product): 0406-1170
NALTREXONE HYDROCHLORIDE	NALTREXONE HYDROCHLORIDE	Bryant Ranch Prepack	10261f2f-e4c1-415c-b722-edeaab97a112	2023-12-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076264 application number: ANDA076264

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
06ff2d5a-e62b-4fa4-bbdb-01938535bc65	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
0406-1170-01	NALTREXONE HYDROCHLORIDE	100 in 1 BOTTLE	TABLET, FILM COATED	100		14
0406-1170-03	NALTREXONE HYDROCHLORIDE	30 in 1 BOTTLE	TABLET, FILM COATED	30		14

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0406-1170-01	EA - Each	0406-1170	b5537e46-f342-4375-b96e-7a39d82bca57	1	2012-07-24
0406-1170-03	EA - Each	0406-1170	f0d4689e-46fb-43e1-8bff-3253c5b0819a	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 [MALLINCKRODT, INC.]	7
NALTREXONE	ACTIVE MOIETY	5S6W795CQM	NALTREXONE HYDROCHLORIDE TABLET, FILM COATED [MALLINCKRODT, INC.]	7
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	NALTREXONE HYDROCHLORIDE TABLET, FILM COATED [MALLINCKRODT, INC.]	7
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	NALTREXONE HYDROCHLORIDE TABLET, FILM COATED [MALLINCKRODT, INC.]	7
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	NALTREXONE HYDROCHLORIDE TABLET, FILM COATED [MALLINCKRODT, INC.]	7
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	NALTREXONE HYDROCHLORIDE TABLET, FILM COATED [MALLINCKRODT, INC.]	7
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	NALTREXONE HYDROCHLORIDE TABLET, FILM COATED [MALLINCKRODT, INC.]	7
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	NALTREXONE HYDROCHLORIDE TABLET, FILM COATED [MALLINCKRODT, INC.]	7
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	NALTREXONE HYDROCHLORIDE TABLET, FILM COATED [MALLINCKRODT, INC.]	7
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	NALTREXONE HYDROCHLORIDE TABLET, FILM COATED [MALLINCKRODT, INC.]	7
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	NALTREXONE HYDROCHLORIDE TABLET, FILM COATED [MALLINCKRODT, INC.]	7
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	NALTREXONE HYDROCHLORIDE TABLET, FILM COATED [MALLINCKRODT, INC.]	7
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	NALTREXONE HYDROCHLORIDE TABLET, FILM COATED [MALLINCKRODT, INC.]	7
NALTREXONE HYDROCHLORIDE	ACTIVE INGREDIENT	Z6375YW9SF	NALTREXONE HYDROCHLORIDE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]	3
NALTREXONE	ACTIVE MOIETY	5S6W795CQM	NALTREXONE HYDROCHLORIDE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]	3
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	NALTREXONE HYDROCHLORIDE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]	3
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	NALTREXONE HYDROCHLORIDE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]	3
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	NALTREXONE HYDROCHLORIDE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]	3
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	NALTREXONE HYDROCHLORIDE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]	3
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	NALTREXONE HYDROCHLORIDE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]	3
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	NALTREXONE HYDROCHLORIDE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]	3
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	NALTREXONE HYDROCHLORIDE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]	3
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	NALTREXONE HYDROCHLORIDE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]	3
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	NALTREXONE HYDROCHLORIDE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]	3
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	NALTREXONE HYDROCHLORIDE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]	3
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	NALTREXONE HYDROCHLORIDE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0406-1170	NALTREXONE HYDROCHLORIDE TABLET, FILM COATED [SPECGX LLC]	14	Current NDC, Legacy NDC, 2 package rows	20240503_06ff2d5a-e62b-4fa4-bbdb-01938535bc65.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	10261f2f-e4c1-415c-b722-edeaab97a112	100
1483744	naltrexone hydrochloride 50 MG Oral Tablet	SCD	10261f2f-e4c1-415c-b722-edeaab97a112	100
1483744	naltrexone HCl 50 MG Oral Tablet	PSN	06ff2d5a-e62b-4fa4-bbdb-01938535bc65	14
1483744	naltrexone hydrochloride 50 MG Oral Tablet	SCD	06ff2d5a-e62b-4fa4-bbdb-01938535bc65	14
1483744	naltrexone HCl 50 MG Oral Tablet	PSN	81e25c6a-81b6-4cfb-91bf-be20c3ae546b	10
1483744	naltrexone hydrochloride 50 MG Oral Tablet	SCD	81e25c6a-81b6-4cfb-91bf-be20c3ae546b	10
1483744	naltrexone HCl 50 MG Oral Tablet	PSN	838a1e88-1179-4a2a-a737-8ce008bb96a7	4
1483744	naltrexone hydrochloride 50 MG Oral Tablet	SCD	838a1e88-1179-4a2a-a737-8ce008bb96a7	4
1483744	naltrexone HCl 50 MG Oral Tablet	PSN	0103a32b-14a9-48a8-8952-b2b12ef09649	3
1483744	naltrexone hydrochloride 50 MG Oral Tablet	SCD	0103a32b-14a9-48a8-8952-b2b12ef09649	3
1483744	naltrexone HCl 50 MG Oral Tablet	PSN	390bff41-7bab-b72a-e063-6294a90ad35d	1
1483744	naltrexone HCl 50 MG Oral Tablet	PSN	3cbd0cad-7c56-ac0a-e063-6294a90a80e4	1
1483744	naltrexone hydrochloride 50 MG Oral Tablet	SCD	390bff41-7bab-b72a-e063-6294a90ad35d	1
1483744	naltrexone hydrochloride 50 MG Oral Tablet	SCD	3cbd0cad-7c56-ac0a-e063-6294a90a80e4	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
0406-1170-01	00406117001	100 TABLET, FILM COATED in 1 BOTTLE (0406-1170-01)	2002-03-22	0000-00-00	No	No	Current
0406-1170-03	00406117003	30 TABLET, FILM COATED in 1 BOTTLE (0406-1170-03)	2002-03-22	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Naltrexone Hydrochloride Tablets USP 50 mg Opioid Antagonist Rx only	A-S Medication Solutions	2025-11-12	HUMAN PRESCRIPTION DRUG LABEL	3
Naltrexone Hydrochloride Tablets USP 50 mg Opioid Antagonist Rx only	Golden State Medical Supply, Inc.	2025-08-19	HUMAN PRESCRIPTION DRUG LABEL	1
Naltrexone Hydrochloride Tablets USP 50 mg Opioid Antagonist Rx only	Aphena Pharma Solutions - Tennessee, LLC	2025-07-03	HUMAN PRESCRIPTION DRUG LABEL	1
Naltrexone Hydrochloride Tablets USP Rx only 8229121/0223	American Health Packaging	2024-08-05	HUMAN PRESCRIPTION DRUG LABEL	10
Naltrexone Hydrochloride Tablets USP 50 mg Opioid Antagonist Rx only	Bryant Ranch Prepack	2024-05-30	HUMAN PRESCRIPTION DRUG LABEL	4
Naltrexone Hydrochloride Tablets USP 50 mg Opioid Antagonist Rx only	Bryant Ranch Prepack	2023-12-07	HUMAN PRESCRIPTION DRUG LABEL	100
Naltrexone Hydrochloride Tablets USP 50 mg Opioid Antagonist Rx only	SpecGx LLC	2023-12-07	HUMAN PRESCRIPTION DRUG LABEL	14
Naltrexone Hydrochloride Tablets USP 50 mg Rx only	REMEDYREPACK INC.	2021-01-13	HUMAN PRESCRIPTION DRUG LABEL	5