NALTREXONE HYDROCHLORIDE

Product NDC
70518-2718
Requested package NDC
70518-2718-1
11-digit product format
705182718
Labeler code
70518
Product ID
70518-2718_4a7e6def-2379-64a5-e063-6394a90a011d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
NALTREXONE HYDROCHLORIDE
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA090356
Marketing category
ANDA
Marketing start
2020-05-01
Substance
NALTREXONE HYDROCHLORIDE
Active strength
50 mg/1
Pharmacologic classes
Opioid Antagonist [EPC], Opioid Antagonists [MoA]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage70518-271870518-2718-1DDiscontinued by firm2026-08-03

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 15 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Code, Status table
Captured / source dateCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31DDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28DDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21DDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10DDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31DDiscontinued by firm302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20DDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10DDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08DDiscontinued by firmad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03DDiscontinued by firm367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09DDiscontinued by firm557ba5c1ecfa…9c80585c8c6e…
2022-08-30 03:57 UTC · source 2022-08-29IInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08IInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01IInactivated by FDAbd6a592717d7…303034d00443…

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A090356-001NALTREXONE HYDROCHLORIDENALTREXONE HYDROCHLORIDE50MGTABLET / ORALAB2012-02-24

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A090356-001AB

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A090356-001NALTREXONE HYDROCHLORIDE50MGTABLET / ORALAB2012-02-24011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090356-001NALTREXONE HYDROCHLORIDE50MGTABLET / ORALAB2012-02-2431067a03dcf5…
2025-08-23 18:47 UTC2025-08A090356-001NALTREXONE HYDROCHLORIDE50MGTABLET / ORALAB2012-02-246a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090356-001NALTREXONE HYDROCHLORIDE50MGTABLET / ORALAB2012-02-24fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090356-001NALTREXONE HYDROCHLORIDE50MGTABLET / ORALAB2012-02-24b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090356-001NALTREXONE HYDROCHLORIDE50MGTABLET / ORALAB2012-02-2403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090356-001NALTREXONE HYDROCHLORIDE50MGTABLET / ORALAB2012-02-242680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090356-001NALTREXONE HYDROCHLORIDE50MGTABLET / ORALAB2012-02-245bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090356-001NALTREXONE HYDROCHLORIDE50MGTABLET / ORALAB2012-02-24d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090356-001NALTREXONE HYDROCHLORIDE50MGTABLET / ORALAB2012-02-24d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090356-001NALTREXONE HYDROCHLORIDE50MGTABLET / ORALAB2012-02-2479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090356-001NALTREXONE HYDROCHLORIDE50MGTABLET / ORALAB2012-02-24301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090356-001NALTREXONE HYDROCHLORIDE50MGTABLET / ORALAB2012-02-241e350fbaab3a…
2024-05-31 18:47 UTC2024-05A090356-001NALTREXONE HYDROCHLORIDE50MGTABLET / ORALAB2012-02-248072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090356-001NALTREXONE HYDROCHLORIDE50MGTABLET / ORALAB2012-02-245c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A090356-001NALTREXONE HYDROCHLORIDE50MGTABLET / ORALAB2012-02-245d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A090356-001NALTREXONE HYDROCHLORIDE50MGTABLET / ORALAB2012-02-244b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A090356-001NALTREXONE HYDROCHLORIDE50MGTABLET / ORALAB2012-02-2474a2ff9319b5…
2022-03-09 01:35 UTC2022-03A090356-001NALTREXONE HYDROCHLORIDE50MGTABLET / ORALAB2012-02-24bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A090356-001NALTREXONE HYDROCHLORIDE50MGTABLET / ORALAB2012-02-24782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A090356-001NALTREXONE HYDROCHLORIDE50MGTABLET / ORALAB2012-02-2487673890dc5c…
2021-03-12 10:30 UTC2021-03A090356-001NALTREXONE HYDROCHLORIDE50MGTABLET / ORALAB2012-02-245aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A090356-001NALTREXONE HYDROCHLORIDE50MGTABLET / ORALAB2012-02-248869cabd3fbd…
2020-11-12 02:37 UTC2020-11A090356-001NALTREXONE HYDROCHLORIDE50MGTABLET / ORALAB2012-02-24c0c555d07b60…
2019-12-14 00:12 UTC2019-12A090356-001NALTREXONE HYDROCHLORIDE50MGTABLET / ORALAB2012-02-243f01610625f2…
2019-09-15 20:21 UTC2019-09A090356-001NALTREXONE HYDROCHLORIDE50MGTABLET / ORALAB2012-02-24b00525d2431f…
2019-07-19 19:46 UTC2019-07A090356-001NALTREXONE HYDROCHLORIDE50MGTABLET / ORALAB2012-02-24ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A090356-001NALTREXONE HYDROCHLORIDE50MGTABLET / ORALAB2012-02-246a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A090356-001NALTREXONE HYDROCHLORIDE50MGTABLET / ORALAB2012-02-241c564ffb4f44…
2023-12-20 04:57 UTC2023-12A090356-001NALTREXONE HYDROCHLORIDE50MGTABLET / ORALAB2012-02-24ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A090356-001NALTREXONE HYDROCHLORIDE50MGTABLET / ORALAB2012-02-24a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A090356-001NALTREXONE HYDROCHLORIDE50MGTABLET / ORALAB2012-02-249b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A090356-001NALTREXONE HYDROCHLORIDE50MGTABLET / ORALAB2012-02-24a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A090356-001NALTREXONE HYDROCHLORIDE50MGTABLET / ORALAB2012-02-243f0d92c62455…
2023-05-13 08:27 UTC2023-05A090356-001NALTREXONE HYDROCHLORIDE50MGTABLET / ORALAB2012-02-24053a50430f4f…
2023-01-26 05:58 UTC2023-01A090356-001NALTREXONE HYDROCHLORIDE50MGTABLET / ORALAB2012-02-243bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A090356-001NALTREXONE HYDROCHLORIDE50MGTABLET / ORALAB2012-02-243a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A090356-001NALTREXONE HYDROCHLORIDE50MGTABLET / ORALAB2012-02-24f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A090356-001NALTREXONE HYDROCHLORIDE50MGTABLET / ORALAB2012-02-24e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A090356-001NALTREXONE HYDROCHLORIDE50MGTABLET / ORALAB2012-02-24cb3db0bc1861…

Observed Orange Book normalized TE history#

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

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A090356-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090356-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A090356-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090356-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090356-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090356-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090356-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090356-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090356-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090356-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090356-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090356-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090356-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A090356-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090356-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A090356-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A090356-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A090356-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A090356-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A090356-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A090356-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A090356-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A090356-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A090356-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A090356-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A090356-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A090356-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A090356-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A090356-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A090356-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A090356-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A090356-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A090356-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A090356-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A090356-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A090356-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A090356-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A090356-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A090356-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A090356-001AB1cb3db0bc1861…

Additional Listing Data#

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

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 SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
f821dd49-3fa7-4d33-99de-19023ff1ae65Available 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

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70518-2718-0NALTREXONE HYDROCHLORIDE30 in 1 BLISTER PACKTABLET, FILM COATED308
70518-2718-1NALTREXONE HYDROCHLORIDE28 in 1 BLISTER PACKTABLET, FILM COATED288

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-2718NALTREXONE HYDROCHLORIDE TABLET, FILM COATED [REMEDYREPACK INC.]6Current NDC, Legacy NDC, 2 package rows20250330_f821dd49-3fa7-4d33-99de-19023ff1ae65.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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
NALTREXONE HYDROCHLORIDENALTREXONE HYDROCHLORIDEREMEDYREPACK INC.f821dd49-3fa7-4d33-99de-19023ff1ae652026-07-28Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090356
application number: ANDA090356
ndc (package): 70518-2718-1
ndc (product): 70518-2718
ndc11 (package): 70518271801
NALTREXONE HYDROCHLORIDENALTREXONE HYDROCHLORIDEBryant Ranch Prepackf9807ec0-3504-4c66-8efe-ea25f84c782b2026-07-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090356
application number: ANDA090356
NALTREXONE HYDROCHLORIDENALTREXONE HYDROCHLORIDEMajor Pharmaceuticals69cb8573-08c1-4957-a768-6cd383f6a3f42026-06-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090356
application number: ANDA090356
NALTREXONE HYDROCHLORIDENALTREXONE HYDROCHLORIDECoupler LLC544f79a7-ca89-795d-e063-6294a90a8a972026-06-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090356
application number: ANDA090356
NALTREXONE HYDROCHLORIDENALTREXONE HYDROCHLORIDESun Pharmaceutical Industries, Inc.0f30f885-d0cd-4fa6-a8e0-142f08a567922026-06-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090356
application number: ANDA090356
NALTREXONE HYDROCHLORIDENALTREXONE HYDROCHLORIDENCS HealthCare of KY, LLC dba Vangard Labsfa2f842f-001a-4f1e-8748-c7852579109c2025-09-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090356
application number: ANDA090356
NALTREXONE HYDROCHLORIDENALTREXONE HYDROCHLORIDEProficient Rx LPf3305f0b-fb9e-4009-b28f-47fe9b1b618b2025-02-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090356
application number: ANDA090356

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1483744naltrexone HCl 50 MG Oral TabletPSNf821dd49-3fa7-4d33-99de-19023ff1ae658
1483744naltrexone hydrochloride 50 MG Oral TabletSCDf821dd49-3fa7-4d33-99de-19023ff1ae658

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70518-2718-17051827180128 TABLET, FILM COATED in 1 BLISTER PACK (70518-2718-1) 2020-11-170000-00-00NoNoCurrent