NALTREXONE HYDROCHLORIDE

Product NDC
68084-291
11-digit product format
680840291
Labeler code
68084
Product ID
68084-291_1ef27c71-786e-4f5e-e063-6294a90a7934
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
naltrexone hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
American Health Packaging
Application
ANDA076264
Marketing category
ANDA
Marketing start
2013-06-03
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 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A076264-001NALTREXONE HYDROCHLORIDENALTREXONE HYDROCHLORIDE25MGTABLET / ORAL2002-03-22
A076264-002NALTREXONE HYDROCHLORIDENALTREXONE HYDROCHLORIDE50MGTABLET / ORALABRS2002-03-22
A076264-003NALTREXONE HYDROCHLORIDENALTREXONE HYDROCHLORIDE100MGTABLET / ORAL2002-03-22

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A076264-002AB

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 4 · 126 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A076264-001NALTREXONE HYDROCHLORIDE25MGTABLET / ORAL2002-03-22caaa826d4ba7…
2026-08-18 06:07:402026-07A076264-002NALTREXONE HYDROCHLORIDE50MGTABLET / ORALABRS2002-03-22caaa826d4ba7…
2026-08-18 06:07:402026-07A076264-003NALTREXONE HYDROCHLORIDE100MGTABLET / ORAL2002-03-22caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A076264-001NALTREXONE HYDROCHLORIDE25MGTABLET / ORAL2002-03-22011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076264-002NALTREXONE HYDROCHLORIDE50MGTABLET / ORALABRS2002-03-22011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076264-003NALTREXONE HYDROCHLORIDE100MGTABLET / ORAL2002-03-22011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076264-001NALTREXONE HYDROCHLORIDE25MGTABLET / ORAL2002-03-2231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076264-002NALTREXONE HYDROCHLORIDE50MGTABLET / ORALABRS2002-03-2231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076264-003NALTREXONE HYDROCHLORIDE100MGTABLET / ORAL2002-03-2231067a03dcf5…
2025-08-23 18:47 UTC2025-08A076264-001NALTREXONE HYDROCHLORIDE25MGTABLET / ORAL2002-03-226a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076264-002NALTREXONE HYDROCHLORIDE50MGTABLET / ORALABRS2002-03-226a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076264-003NALTREXONE HYDROCHLORIDE100MGTABLET / ORAL2002-03-226a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076264-001NALTREXONE HYDROCHLORIDE25MGTABLET / ORAL2002-03-22fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076264-002NALTREXONE HYDROCHLORIDE50MGTABLET / ORALABRS2002-03-22fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076264-003NALTREXONE HYDROCHLORIDE100MGTABLET / ORAL2002-03-22fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076264-001NALTREXONE HYDROCHLORIDE25MGTABLET / ORAL2002-03-22b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076264-002NALTREXONE HYDROCHLORIDE50MGTABLET / ORALABRS2002-03-22b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076264-003NALTREXONE HYDROCHLORIDE100MGTABLET / ORAL2002-03-22b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076264-001NALTREXONE HYDROCHLORIDE25MGTABLET / ORAL2002-03-2203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076264-002NALTREXONE HYDROCHLORIDE50MGTABLET / ORALABRS2002-03-2203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076264-003NALTREXONE HYDROCHLORIDE100MGTABLET / ORAL2002-03-2203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076264-001NALTREXONE HYDROCHLORIDE25MGTABLET / ORAL2002-03-222680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076264-002NALTREXONE HYDROCHLORIDE50MGTABLET / ORALABRS2002-03-222680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076264-003NALTREXONE HYDROCHLORIDE100MGTABLET / ORAL2002-03-222680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076264-001NALTREXONE HYDROCHLORIDE25MGTABLET / ORAL2002-03-225bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076264-002NALTREXONE HYDROCHLORIDE50MGTABLET / ORALABRS2002-03-225bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076264-003NALTREXONE HYDROCHLORIDE100MGTABLET / ORAL2002-03-225bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076264-001NALTREXONE HYDROCHLORIDE25MGTABLET / ORAL2002-03-22d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076264-002NALTREXONE HYDROCHLORIDE50MGTABLET / ORALABRS2002-03-22d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076264-003NALTREXONE HYDROCHLORIDE100MGTABLET / ORAL2002-03-22d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A076264-001NALTREXONE HYDROCHLORIDE25MGTABLET / ORAL2002-03-22d06236e962d9…
2024-10-29 15:01 UTC2024-10A076264-002NALTREXONE HYDROCHLORIDE50MGTABLET / ORALABRS2002-03-22d06236e962d9…
2024-10-29 15:01 UTC2024-10A076264-003NALTREXONE HYDROCHLORIDE100MGTABLET / ORAL2002-03-22d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076264-001NALTREXONE HYDROCHLORIDE25MGTABLET / ORAL2002-03-2279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076264-002NALTREXONE HYDROCHLORIDE50MGTABLET / ORALABRS2002-03-2279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076264-003NALTREXONE HYDROCHLORIDE100MGTABLET / ORAL2002-03-2279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076264-001NALTREXONE HYDROCHLORIDE25MGTABLET / ORAL2002-03-22301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076264-002NALTREXONE HYDROCHLORIDE50MGTABLET / ORALABRS2002-03-22301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076264-003NALTREXONE HYDROCHLORIDE100MGTABLET / ORAL2002-03-22301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076264-001NALTREXONE HYDROCHLORIDE25MGTABLET / ORAL2002-03-221e350fbaab3a…

Observed Orange Book normalized TE history#

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

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A076264-002AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A076264-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076264-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A076264-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076264-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076264-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076264-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076264-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076264-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076264-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A076264-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076264-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076264-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076264-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A076264-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A076264-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A076264-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A076264-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A076264-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A076264-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A076264-002AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A076264-002AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A076264-002AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A076264-002AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A076264-002AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A076264-002AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A076264-002AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A076264-002AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A076264-002AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A076264-002AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A076264-002AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A076264-002AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A076264-002AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A076264-002AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A076264-002AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A076264-002AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A076264-002AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A076264-002AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A076264-002AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A076264-002AB1e64feba35796…

Additional Listing Data#

Finished product
Yes
Brand name base
NALTREXONE HYDROCHLORIDE
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NALTREXONE HYDROCHLORIDE50 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
Z6375YW9SFInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1483744Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
81e25c6a-81b6-4cfb-91bf-be20c3ae546bAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
31849934-38d8-47fe-b84a-4d392838c14bProduct name120170823
8e48b6b8-3a2f-4e0d-b7c9-38d70393b778Product name120161103
e4d463bc-c674-43cb-be06-82786f310d01Product name120150326
7a537f54-d322-5e54-a3a2-035d3e21c3c6Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68084-291-11NALTREXONE HYDROCHLORIDE1 in 1 BLISTER PACKTABLET, FILM COATED110
68084-291-21NALTREXONE HYDROCHLORIDE30 in 1 BOX, UNIT-DOSETABLET, FILM COATED3010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68084-291-11EA - Each68084-291b9c42d33-36dc-4e21-a80d-0cb110320eff12013-02-13
68084-291-21EA - Each68084-2911b38f247-09ce-44f1-8f0d-4e353e117d4512013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
NALTREXONE HYDROCHLORIDEACTIVE INGREDIENTZ6375YW9SFNALTREXONE HYDROCHLORIDE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]3
NALTREXONEACTIVE MOIETY5S6W795CQMNALTREXONE HYDROCHLORIDE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UNALTREXONE HYDROCHLORIDE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]3
CROSPOVIDONEINACTIVE INGREDIENT68401960MKNALTREXONE HYDROCHLORIDE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]3
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675NALTREXONE HYDROCHLORIDE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]3
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTNALTREXONE HYDROCHLORIDE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]3
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WONALTREXONE HYDROCHLORIDE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]3
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XNALTREXONE HYDROCHLORIDE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30NALTREXONE HYDROCHLORIDE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]3
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ANALTREXONE HYDROCHLORIDE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]3
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HNALTREXONE HYDROCHLORIDE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]3
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4NALTREXONE HYDROCHLORIDE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPNALTREXONE HYDROCHLORIDE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68084-291NALTREXONE HYDROCHLORIDE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]10Current NDC, Legacy NDC, 2 package rows20240806_81e25c6a-81b6-4cfb-91bf-be20c3ae546b.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 · 8 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
NALTREXONE HYDROCHLORIDENALTREXONE HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLC43cd6961-4793-85ee-e063-6294a90ad7722025-11-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076264
application number: ANDA076264
NALTREXONE HYDROCHLORIDENALTREXONE HYDROCHLORIDEA-S Medication Solutions0103a32b-14a9-48a8-8952-b2b12ef096492025-11-12Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076264
application number: ANDA076264
NALTREXONE HYDROCHLORIDENALTREXONE HYDROCHLORIDEGolden State Medical Supply, Inc.3cbd0cad-7c56-ac0a-e063-6294a90a80e42025-08-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076264
application number: ANDA076264
NALTREXONE HYDROCHLORIDENALTREXONE HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLC390bff41-7bab-b72a-e063-6294a90ad35d2025-07-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076264
application number: ANDA076264
NALTREXONE HYDROCHLORIDENALTREXONE HYDROCHLORIDEAmerican Health Packaging81e25c6a-81b6-4cfb-91bf-be20c3ae546b2024-08-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076264
application number: ANDA076264
ndc (product): 68084-291
NALTREXONE HYDROCHLORIDENALTREXONE HYDROCHLORIDEBryant Ranch Prepack838a1e88-1179-4a2a-a737-8ce008bb96a72024-05-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076264
application number: ANDA076264
NALTREXONE HYDROCHLORIDENALTREXONE HYDROCHLORIDESpecGx LLC06ff2d5a-e62b-4fa4-bbdb-01938535bc652023-12-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076264
application number: ANDA076264
NALTREXONE HYDROCHLORIDENALTREXONE HYDROCHLORIDEBryant Ranch Prepack10261f2f-e4c1-415c-b722-edeaab97a1122023-12-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076264
application number: ANDA076264

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1483744naltrexone HCl 50 MG Oral TabletPSN81e25c6a-81b6-4cfb-91bf-be20c3ae546b10
1483744naltrexone hydrochloride 50 MG Oral TabletSCD81e25c6a-81b6-4cfb-91bf-be20c3ae546b10

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68084-291-11680840291111 in 1 BLISTER PACKHistorical
68084-291-216808402912130 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-291-21) / 1 TABLET, FILM COATED in 1 BLISTER PACK (68084-291-11) 30 blister pack2013-06-030000-00-00NoNoCurrent