NALTREXONE HYDROCHLORIDE

Product NDC
50090-3929
11-digit product format
500903929
Labeler code
50090
Product ID
50090-3929_7b8b9aa6-4484-4b2b-b17f-63042d1b467c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
NALTREXONE HYDROCHLORIDE
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA090356
Marketing category
ANDA
Marketing start
2012-02-29
Marketing end
0000-00-00
Substance
NALTREXONE HYDROCHLORIDE
Active strength
50 mg/1
Pharmacologic classes
Opioid Antagonist [EPC],Opioid Antagonists [MoA]
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct50090-3929IInactivated by FDA2026-08-17
excluded packagepackage50090-392950090-3929-0IInactivated by FDA2026-08-17

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 · 30 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage50090-3929-0d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage50090-3929-0f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage50090-3929-02ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage50090-3929-0a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage50090-3929-0cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage50090-3929-0cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage50090-3929-0302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage50090-3929-0ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage50090-3929-00efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage50090-3929-0ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage50090-3929-0367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage50090-3929-0557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage50090-3929-08af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage50090-3929-0834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage50090-3929-01332a3947898…d4bfe170f9cd…

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-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 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A090356-001NALTREXONE HYDROCHLORIDE50MGTABLET / ORALAB2012-02-24caaa826d4ba7…
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…

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 06:07:402026-07A090356-001AB1caaa826d4ba7…
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…

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#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-3929-02023-01-30C16284748780-1f386c649-cc6d-0266-e053-dadaa90a7c1aNaltrexone Hydrochloride Tablets, USP Opioid Antagonist

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-3929-0NALTREXONE HYDROCHLORIDE30 in 1 BOTTLETABLET, FILM COATED304

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-3929NALTREXONE HYDROCHLORIDE TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]4Legacy NDC, 1 package rows20200122_e71de213-5250-4a63-9ef7-9ef2f9954d8b.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
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 TabletPSNe71de213-5250-4a63-9ef7-9ef2f9954d8b4
1483744naltrexone hydrochloride 50 MG Oral TabletSCDe71de213-5250-4a63-9ef7-9ef2f9954d8b4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-3929-05009039290030 TABLET, FILM COATED in 1 BOTTLE (50090-3929-0) 2018-12-070000-00-00NoNoCurrent