Naltrexone Hydrochloride

Product NDC
68071-2721
11-digit product format
680712721
Labeler code
68071
Product ID
68071-2721_df73db00-ef4d-4e7c-e053-2a95a90a62fc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Naltrexone Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
NuCare Pharmceuticals,Inc.
Application
ANDA091205
Marketing category
ANDA
Marketing start
2012-01-18
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
2023-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct68071-2721IInactivated by FDA2026-08-03
excluded packagepackage68071-272168071-2721-3IInactivated by FDA2026-08-03

Observed NDC auxiliary status history#

Observed captured status history: Rows come only from successfully parsed FDA auxiliary ZIP captures. They show the state present in that artifact, not a continuous regulatory timeline. Absence before, after, or between captures is not proof of status, and a known non-data HTTP 403 capture is preserved in backfill provenance but cannot produce a status row.

Historic NDC status page 1 of 1 · 18 matching rows.

Browse every current auxiliary row. · Browse the complete NDC auxiliary source catalog.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproduct68071-2721IInactivated by FDAexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage68071-272168071-2721-3IInactivated by FDAexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproduct68071-2721IInactivated by FDAexcluded / ndc_excluded.zipf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage68071-272168071-2721-3IInactivated by FDAexcluded / ndc_excluded.zipf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct68071-2721IInactivated by FDAexcluded / ndc_excluded.zip2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage68071-272168071-2721-3IInactivated by FDAexcluded / ndc_excluded.zip2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproduct68071-2721IInactivated by FDAexcluded / ndc_excluded.zipa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage68071-272168071-2721-3IInactivated by FDAexcluded / ndc_excluded.zipa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproduct68071-2721IInactivated by FDAexcluded / ndc_excluded.zipcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage68071-272168071-2721-3IInactivated by FDAexcluded / ndc_excluded.zipcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproduct68071-2721IInactivated by FDAexcluded / ndc_excluded.zipcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage68071-272168071-2721-3IInactivated by FDAexcluded / ndc_excluded.zipcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct68071-2721UExcluded because listing certification expiredexcluded / ndc_excluded.zip302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage68071-272168071-2721-3UExcluded because listing certification expiredexcluded / ndc_excluded.zip302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproduct68071-2721UExcluded because listing certification expiredexcluded / ndc_excluded.ziped331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage68071-272168071-2721-3UExcluded because listing certification expiredexcluded / ndc_excluded.ziped331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct68071-2721UExcluded because listing certification expiredexcluded / ndc_excluded.zip0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage68071-272168071-2721-3UExcluded because listing certification expiredexcluded / ndc_excluded.zip0efc9e666f02…f202fb6c5f17…

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
A091205-001NALTREXONE HYDROCHLORIDENALTREXONE HYDROCHLORIDE50MGTABLET / ORALAB2011-08-17

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A091205-001AB

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 UTC2026-02A091205-001NALTREXONE HYDROCHLORIDE50MGTABLET / ORALAB2011-08-17011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091205-001NALTREXONE HYDROCHLORIDE50MGTABLET / ORALAB2011-08-1731067a03dcf5…
2025-08-23 18:47 UTC2025-08A091205-001NALTREXONE HYDROCHLORIDE50MGTABLET / ORALAB2011-08-176a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091205-001NALTREXONE HYDROCHLORIDE50MGTABLET / ORALAB2011-08-17fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091205-001NALTREXONE HYDROCHLORIDE50MGTABLET / ORALAB2011-08-17b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091205-001NALTREXONE HYDROCHLORIDE50MGTABLET / ORALAB2011-08-1703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091205-001NALTREXONE HYDROCHLORIDE50MGTABLET / ORALAB2011-08-172680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091205-001NALTREXONE HYDROCHLORIDE50MGTABLET / ORALAB2011-08-175bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091205-001NALTREXONE HYDROCHLORIDE50MGTABLET / ORALAB2011-08-17d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A091205-001NALTREXONE HYDROCHLORIDE50MGTABLET / ORALAB2011-08-17d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A091205-001NALTREXONE HYDROCHLORIDE50MGTABLET / ORALAB2011-08-1779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A091205-001NALTREXONE HYDROCHLORIDE50MGTABLET / ORALAB2011-08-17301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A091205-001NALTREXONE HYDROCHLORIDE50MGTABLET / ORALAB2011-08-171e350fbaab3a…
2024-05-31 18:47 UTC2024-05A091205-001NALTREXONE HYDROCHLORIDE50MGTABLET / ORALAB2011-08-178072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A091205-001NALTREXONE HYDROCHLORIDE50MGTABLET / ORALAB2011-08-175c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A091205-001NALTREXONE HYDROCHLORIDE50MGTABLET / ORALAB2011-08-175d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A091205-001NALTREXONE HYDROCHLORIDE50MGTABLET / ORALAB2011-08-174b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A091205-001NALTREXONE HYDROCHLORIDE50MGTABLET / ORALAB2011-08-1774a2ff9319b5…
2022-03-09 01:35 UTC2022-03A091205-001NALTREXONE HYDROCHLORIDE50MGTABLET / ORALAB2011-08-17bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A091205-001NALTREXONE HYDROCHLORIDE50MGTABLET / ORALAB2011-08-17782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A091205-001NALTREXONE HYDROCHLORIDE50MGTABLET / ORALAB2011-08-1787673890dc5c…
2021-03-12 10:30 UTC2021-03A091205-001NALTREXONE HYDROCHLORIDE50MGTABLET / ORALAB2011-08-175aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A091205-001NALTREXONE HYDROCHLORIDE50MGTABLET / ORALAB2011-08-178869cabd3fbd…
2020-11-12 02:37 UTC2020-11A091205-001NALTREXONE HYDROCHLORIDE50MGTABLET / ORALAB2011-08-17c0c555d07b60…
2019-12-14 00:12 UTC2019-12A091205-001NALTREXONE HYDROCHLORIDE50MGTABLET / ORALAB2011-08-173f01610625f2…
2019-09-15 20:21 UTC2019-09A091205-001NALTREXONE HYDROCHLORIDE50MGTABLET / ORALAB2011-08-17b00525d2431f…
2019-07-19 19:46 UTC2019-07A091205-001NALTREXONE HYDROCHLORIDE50MGTABLET / ORALAB2011-08-17ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A091205-001NALTREXONE HYDROCHLORIDE50MGTABLET / ORALAB2011-08-176a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A091205-001NALTREXONE HYDROCHLORIDE50MGTABLET / ORALAB2011-08-171c564ffb4f44…
2023-12-20 04:57 UTC2023-12A091205-001NALTREXONE HYDROCHLORIDE50MGTABLET / ORALAB2011-08-17ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A091205-001NALTREXONE HYDROCHLORIDE50MGTABLET / ORALAB2011-08-17a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A091205-001NALTREXONE HYDROCHLORIDE50MGTABLET / ORALAB2011-08-179b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A091205-001NALTREXONE HYDROCHLORIDE50MGTABLET / ORALAB2011-08-17a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A091205-001NALTREXONE HYDROCHLORIDE50MGTABLET / ORALAB2011-08-173f0d92c62455…
2023-05-13 08:27 UTC2023-05A091205-001NALTREXONE HYDROCHLORIDE50MGTABLET / ORALAB2011-08-17053a50430f4f…
2023-01-26 05:58 UTC2023-01A091205-001NALTREXONE HYDROCHLORIDE50MGTABLET / ORALAB2011-08-173bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A091205-001NALTREXONE HYDROCHLORIDE50MGTABLET / ORALAB2011-08-173a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A091205-001NALTREXONE HYDROCHLORIDE50MGTABLET / ORALAB2011-08-17f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A091205-001NALTREXONE HYDROCHLORIDE50MGTABLET / ORALAB2011-08-17e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A091205-001NALTREXONE HYDROCHLORIDE50MGTABLET / ORALAB2011-08-17cb3db0bc1861…

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 UTC2026-02A091205-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091205-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A091205-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091205-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091205-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091205-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091205-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091205-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091205-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A091205-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A091205-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A091205-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A091205-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A091205-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A091205-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A091205-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A091205-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A091205-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A091205-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A091205-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A091205-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A091205-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A091205-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A091205-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A091205-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A091205-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A091205-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A091205-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A091205-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A091205-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A091205-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A091205-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A091205-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A091205-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A091205-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A091205-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A091205-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A091205-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A091205-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A091205-001AB1cb3db0bc1861…

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 · 4 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Naltrexone HydrochlorideNALTREXONE HYDROCHLORIDERedpharm Drug57439bad-00f0-5696-e063-6294a90a2ea52026-07-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091205
application number: ANDA091205
Naltrexone HydrochlorideNALTREXONE HYDROCHLORIDEBryant Ranch Prepackfa0b0881-97f3-4ca2-bc15-0954293081db2026-05-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091205
application number: ANDA091205
Naltrexone HydrochlorideNALTREXONE HYDROCHLORIDEAccord Healthcare, Inc.49aa3d6d-2270-4615-aafa-b440859ab8702025-10-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091205
application number: ANDA091205
Naltrexone HydrochlorideNALTREXONE HYDROCHLORIDEA-S Medication Solutions00c04ff4-b6f2-466c-9ab9-813a60577db02023-12-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091205
application number: ANDA091205

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
68071-2721-32025-01-30C16284748780-12cef2736-8596-d83d-e063-dadaa90ab31fNaltrexone Hydrochloride Tablets USP 50 mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-2721-3Naltrexone Hydrochloride30 in 1 BOTTLETABLET, FILM COATED301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-2721NALTREXONE HYDROCHLORIDE TABLET, FILM COATED [NUCARE PHARMCEUTICALS,INC.]1Legacy NDC, 1 package rows20220521_df73d163-8fd0-3c8f-e053-2a95a90a832e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1483744naltrexone HCl 50 MG Oral TabletPSNdf73d163-8fd0-3c8f-e053-2a95a90a832e1
1483744naltrexone hydrochloride 50 MG Oral TabletSCDdf73d163-8fd0-3c8f-e053-2a95a90a832e1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68071-2721-36807127210330 TABLET, FILM COATED in 1 BOTTLE (68071-2721-3) 2022-05-200000-00-00NoNoCurrent