Naltrexone Hydrochloride

Product NDC: 51224-206
11-digit product format: 512240206
Labeler code: 51224
Product ID: 51224-206_75a00517-674b-4e87-b37b-598486aedf03
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Naltrexone Hydrochloride
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: TAGI Pharma Inc.
Application: ANDA075274
Marketing category: ANDA
Marketing start: 2013-09-23
Marketing end: 2027-11-30
Substance: NALTREXONE HYDROCHLORIDE
Active strength: 50 mg/1
Pharmacologic classes: Opioid Antagonist [EPC], Opioid Antagonists [MoA]
NDC exclude flag: No
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…`

Additional Listing Data#

Finished product: Yes
Brand name base: Naltrexone Hydrochloride

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
60276f5c-657a-4b60-bcd0-44234903d7e0	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
51224-206-30	Naltrexone Hydrochloride	30 in 1 BOTTLE	TABLET, FILM COATED	30		5
51224-206-50	Naltrexone Hydrochloride	100 in 1 BOTTLE	TABLET, FILM COATED	100		5

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
51224-206-30	EA - Each	51224-206	d9c7a3fb-55fc-4e61-bc03-3451bf2ff510	1	2014-04-03
51224-206-50	EA - Each	51224-206	d8b9163b-7bbf-4339-9a8b-78039fa684c9	1	2014-04-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
naltrexone Hydrochloride	ACTIVE INGREDIENT	Z6375YW9SF	NALTREXONE HYDROCHLORIDE TABLET, FILM COATED [PRECISION DOSE INC.]	1
Naltrexone Hydrochloride	ACTIVE INGREDIENT	Z6375YW9SF	NALTREXONE HYDROCHLORIDE TABLET, FILM COATED [TAGI PHARMA INC.]	1
Naltrexone Hydrochloride	ACTIVE INGREDIENT	Z6375YW9SF	NALTREXONE HYDROCHLORIDE (NALTREXONE HYDROCHLORIDE) TABLET, FILM COATED [AVKARE, INC.]	1
Naltrexone	ACTIVE MOIETY	5S6W795CQM	NALTREXONE HYDROCHLORIDE TABLET, FILM COATED [TAGI PHARMA INC.]	1
naltrexone	ACTIVE MOIETY	5S6W795CQM	NALTREXONE HYDROCHLORIDE TABLET, FILM COATED [PRECISION DOSE INC.]	1
Naltrexone	ACTIVE MOIETY	5S6W795CQM	NALTREXONE HYDROCHLORIDE (NALTREXONE HYDROCHLORIDE) TABLET, FILM COATED [AVKARE, INC.]	1
anhydrous lactose	INACTIVE INGREDIENT	3SY5LH9PMK	NALTREXONE HYDROCHLORIDE (NALTREXONE HYDROCHLORIDE) TABLET, FILM COATED [AVKARE, INC.]	1
anhydrous lactose	INACTIVE INGREDIENT	3SY5LH9PMK	NALTREXONE HYDROCHLORIDE TABLET, FILM COATED [TAGI PHARMA INC.]	1
anhydrous lactose	INACTIVE INGREDIENT	3SY5LH9PMK	NALTREXONE HYDROCHLORIDE TABLET, FILM COATED [PRECISION DOSE INC.]	1
cellulose, microcrystalline	INACTIVE INGREDIENT	OP1R32D61U	NALTREXONE HYDROCHLORIDE TABLET, FILM COATED [PRECISION DOSE INC.]	1
cellulose, microcrystalline	INACTIVE INGREDIENT	OP1R32D61U	NALTREXONE HYDROCHLORIDE TABLET, FILM COATED [TAGI PHARMA INC.]	1
cellulose, microcrystalline	INACTIVE INGREDIENT	OP1R32D61U	NALTREXONE HYDROCHLORIDE (NALTREXONE HYDROCHLORIDE) TABLET, FILM COATED [AVKARE, INC.]	1
croscarmellose sodium	INACTIVE INGREDIENT	M28OL1HH48	NALTREXONE HYDROCHLORIDE TABLET, FILM COATED [TAGI PHARMA INC.]	1
croscarmellose sodium	INACTIVE INGREDIENT	M28OL1HH48	NALTREXONE HYDROCHLORIDE TABLET, FILM COATED [PRECISION DOSE INC.]	1
croscarmellose sodium	INACTIVE INGREDIENT	M28OL1HH48	NALTREXONE HYDROCHLORIDE (NALTREXONE HYDROCHLORIDE) TABLET, FILM COATED [AVKARE, INC.]	1
ferric oxide yellow	INACTIVE INGREDIENT	EX438O2MRT	NALTREXONE HYDROCHLORIDE (NALTREXONE HYDROCHLORIDE) TABLET, FILM COATED [AVKARE, INC.]	1
ferric oxide yellow	INACTIVE INGREDIENT	EX438O2MRT	NALTREXONE HYDROCHLORIDE TABLET, FILM COATED [TAGI PHARMA INC.]	1
ferric oxide yellow	INACTIVE INGREDIENT	EX438O2MRT	NALTREXONE HYDROCHLORIDE TABLET, FILM COATED [PRECISION DOSE INC.]	1
hydroxypropyl cellulose (type h)	INACTIVE INGREDIENT	RFW2ET671P	NALTREXONE HYDROCHLORIDE TABLET, FILM COATED [TAGI PHARMA INC.]	1
hydroxypropyl cellulose (type h)	INACTIVE INGREDIENT	RFW2ET671P	NALTREXONE HYDROCHLORIDE TABLET, FILM COATED [PRECISION DOSE INC.]	1
hydroxypropyl cellulose (type h)	INACTIVE INGREDIENT	RFW2ET671P	NALTREXONE HYDROCHLORIDE (NALTREXONE HYDROCHLORIDE) TABLET, FILM COATED [AVKARE, INC.]	1
hypromelloses	INACTIVE INGREDIENT	3NXW29V3WO	NALTREXONE HYDROCHLORIDE TABLET, FILM COATED [TAGI PHARMA INC.]	1
hypromelloses	INACTIVE INGREDIENT	3NXW29V3WO	NALTREXONE HYDROCHLORIDE TABLET, FILM COATED [PRECISION DOSE INC.]	1
hypromelloses	INACTIVE INGREDIENT	3NXW29V3WO	NALTREXONE HYDROCHLORIDE (NALTREXONE HYDROCHLORIDE) TABLET, FILM COATED [AVKARE, INC.]	1
magnesium stearate	INACTIVE INGREDIENT	70097M6I30	NALTREXONE HYDROCHLORIDE TABLET, FILM COATED [PRECISION DOSE INC.]	1
magnesium stearate	INACTIVE INGREDIENT	70097M6I30	NALTREXONE HYDROCHLORIDE (NALTREXONE HYDROCHLORIDE) TABLET, FILM COATED [AVKARE, INC.]	1
magnesium stearate	INACTIVE INGREDIENT	70097M6I30	NALTREXONE HYDROCHLORIDE TABLET, FILM COATED [TAGI PHARMA INC.]	1
polyethylene glycols	INACTIVE INGREDIENT	3WJQ0SDW1A	NALTREXONE HYDROCHLORIDE TABLET, FILM COATED [PRECISION DOSE INC.]	1
polyethylene glycols	INACTIVE INGREDIENT	3WJQ0SDW1A	NALTREXONE HYDROCHLORIDE TABLET, FILM COATED [TAGI PHARMA INC.]	1
polyethylene glycols	INACTIVE INGREDIENT	3WJQ0SDW1A	NALTREXONE HYDROCHLORIDE (NALTREXONE HYDROCHLORIDE) TABLET, FILM COATED [AVKARE, INC.]	1
silicon dioxide	INACTIVE INGREDIENT	ETJ7Z6XBU4	NALTREXONE HYDROCHLORIDE TABLET, FILM COATED [PRECISION DOSE INC.]	1
silicon dioxide	INACTIVE INGREDIENT	ETJ7Z6XBU4	NALTREXONE HYDROCHLORIDE TABLET, FILM COATED [TAGI PHARMA INC.]	1
silicon dioxide	INACTIVE INGREDIENT	ETJ7Z6XBU4	NALTREXONE HYDROCHLORIDE (NALTREXONE HYDROCHLORIDE) TABLET, FILM COATED [AVKARE, INC.]	1
titanium dioxide	INACTIVE INGREDIENT	15FIX9V2JP	NALTREXONE HYDROCHLORIDE TABLET, FILM COATED [PRECISION DOSE INC.]	1
titanium dioxide	INACTIVE INGREDIENT	15FIX9V2JP	NALTREXONE HYDROCHLORIDE TABLET, FILM COATED [TAGI PHARMA INC.]	1
titanium dioxide	INACTIVE INGREDIENT	15FIX9V2JP	NALTREXONE HYDROCHLORIDE (NALTREXONE HYDROCHLORIDE) TABLET, FILM COATED [AVKARE, INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
51224-206	NALTREXONE HYDROCHLORIDE TABLET, FILM COATED [TAGI PHARMA INC.]	4	Current NDC, Legacy NDC, 2 package rows	20190619_60276f5c-657a-4b60-bcd0-44234903d7e0.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 2 · 24 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	57e8b767-54c2-dfa3-e063-6394a90ae6c2	2026-07-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075274 application number: ANDA075274
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 ndc (product): 51224-206
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

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	49b7b694-6fec-479b-be35-d03d816e13dd	101
1483744	naltrexone hydrochloride 50 MG Oral Tablet	SCD	49b7b694-6fec-479b-be35-d03d816e13dd	101
1483744	naltrexone HCl 50 MG Oral Tablet	PSN	13359275-0a7f-48c8-b14a-588d7c0b5f84	12
1483744	naltrexone hydrochloride 50 MG Oral Tablet	SCD	13359275-0a7f-48c8-b14a-588d7c0b5f84	12
1483744	naltrexone HCl 50 MG Oral Tablet	PSN	21b43dab-015c-c82f-ba6e-27da0ec12fc5	10
1483744	naltrexone hydrochloride 50 MG Oral Tablet	SCD	21b43dab-015c-c82f-ba6e-27da0ec12fc5	10
1483744	naltrexone HCl 50 MG Oral Tablet	PSN	74087d2f-468d-4de1-a2fc-a489d0f2abef	6
1483744	naltrexone HCl 50 MG Oral Tablet	PSN	b773726e-1dc9-415a-81f3-32b43b61b9b1	6
1483744	naltrexone hydrochloride 50 MG Oral Tablet	SCD	74087d2f-468d-4de1-a2fc-a489d0f2abef	6
1483744	naltrexone hydrochloride 50 MG Oral Tablet	SCD	b773726e-1dc9-415a-81f3-32b43b61b9b1	6
1483744	naltrexone HCl 50 MG Oral Tablet	PSN	60276f5c-657a-4b60-bcd0-44234903d7e0	5
1483744	naltrexone hydrochloride 50 MG Oral Tablet	SCD	60276f5c-657a-4b60-bcd0-44234903d7e0	5
1483744	naltrexone HCl 50 MG Oral Tablet	PSN	48f0b37b-b1cb-4cc9-ae58-4695e9a501e1	3
1483744	naltrexone hydrochloride 50 MG Oral Tablet	SCD	48f0b37b-b1cb-4cc9-ae58-4695e9a501e1	3
1483744	naltrexone HCl 50 MG Oral Tablet	PSN	db911559-26f5-43a0-b61f-3425176c936f	2
1483744	naltrexone hydrochloride 50 MG Oral Tablet	SCD	db911559-26f5-43a0-b61f-3425176c936f	2
1483744	naltrexone HCl 50 MG Oral Tablet	PSN	7976b328-ad8e-4208-9f61-19cd5ab5f36b	1
1483744	naltrexone HCl 50 MG Oral Tablet	PSN	f58d9be1-a428-45df-9c0b-369e93e71c6a	1
1483744	naltrexone hydrochloride 50 MG Oral Tablet	SCD	7976b328-ad8e-4208-9f61-19cd5ab5f36b	1
1483744	naltrexone hydrochloride 50 MG Oral Tablet	SCD	f58d9be1-a428-45df-9c0b-369e93e71c6a	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
51224-206-30	51224020630	30 TABLET, FILM COATED in 1 BOTTLE (51224-206-30)	2013-09-23	2027-11-30	No	No	Current
51224-206-50	51224020650	100 TABLET, FILM COATED in 1 BOTTLE (51224-206-50)	2013-09-23	2027-11-30	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Naltrexone Hydrochloride Tablets, USP	Coupler LLC \| Elite Laboratories, Inc.	2026-05-27	HUMAN PRESCRIPTION DRUG LABEL	1
Naltrexone Hydrochloride Tablets, USP	Bryant Ranch Prepack	2026-03-16	HUMAN PRESCRIPTION DRUG LABEL	1
Naltrexone Hydrochloride Tablets, USP	Bryant Ranch Prepack	2026-03-10	HUMAN PRESCRIPTION DRUG LABEL	6
Naltrexone Hydrochloride Tablets, USP	AvKARE	2026-02-05	HUMAN PRESCRIPTION DRUG LABEL	10
Naltrexone Hydrochloride Tablets, USP	TAGI Pharma Inc. \| Elite Laboratories, Inc.	2025-11-18	HUMAN PRESCRIPTION DRUG LABEL	5
Naltrexone Hydrochloride Tablets, USP 50 mg	REMEDYREPACK INC.	2025-10-02	HUMAN PRESCRIPTION DRUG LABEL	2
Naltrexone Hydrochloride Tablets, USP 50 mg	Precision Dose Inc.	2025-07-09	HUMAN PRESCRIPTION DRUG LABEL	6
Naltrexone Hydrochloride Tablets, USP 50 mg	Bryant Ranch Prepack	2023-12-05	HUMAN PRESCRIPTION DRUG LABEL	101
Naltrexone Hydrochloride Tablets, USP 50 mg	Bryant Ranch Prepack	2023-01-25	HUMAN PRESCRIPTION DRUG LABEL	6
Naltrexone Hydrochloride Tablets, USP 50 mg	A-S Medication Solutions	2021-09-01	HUMAN PRESCRIPTION DRUG LABEL	3
Naltrexone Hydrochloride Tablets USP, film coated	NuCare Pharmaceuticls, Inc. \| NuCare Pharmaceuticals, Inc.	2020-09-17	HUMAN PRESCRIPTION DRUG LABEL	2
Naltrexone Hydrochloride Tablets, USP 50 mg	A-S Medication Solutions	2020-01-18	HUMAN PRESCRIPTION DRUG LABEL	12
Naltrexone Hydrochloride Tablets USP, film coated	Aidarex Pharmaceuticals LLC	2017-03-10	HUMAN PRESCRIPTION DRUG LABEL	1