Naltrexone Hydrochloride

Product NDC
71335-3012
11-digit product format
713353012
Labeler code
71335
Product ID
71335-3012_14ac2818-29aa-4225-8e02-48e0b3e189f3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Naltrexone Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA075274
Marketing category
ANDA
Marketing start
2025-08-15
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 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
A075274-001NALTREXONE HYDROCHLORIDENALTREXONE HYDROCHLORIDE50MGTABLET / ORALAB1999-05-26

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A075274-001AB

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 UTC2026-02A075274-001NALTREXONE HYDROCHLORIDE50MGTABLET / ORALAB1999-05-26011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075274-001NALTREXONE HYDROCHLORIDE50MGTABLET / ORALAB1999-05-2631067a03dcf5…
2025-08-23 18:47 UTC2025-08A075274-001NALTREXONE HYDROCHLORIDE50MGTABLET / ORALAB1999-05-266a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075274-001NALTREXONE HYDROCHLORIDE50MGTABLET / ORALAB1999-05-26fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075274-001NALTREXONE HYDROCHLORIDE50MGTABLET / ORALAB1999-05-26b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075274-001NALTREXONE HYDROCHLORIDE50MGTABLET / ORALAB1999-05-2603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075274-001NALTREXONE HYDROCHLORIDE50MGTABLET / ORALAB1999-05-262680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075274-001NALTREXONE HYDROCHLORIDE50MGTABLET / ORALAB1999-05-265bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075274-001NALTREXONE HYDROCHLORIDE50MGTABLET / ORALAB1999-05-26d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A075274-001NALTREXONE HYDROCHLORIDE50MGTABLET / ORALAB1999-05-26d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075274-001NALTREXONE HYDROCHLORIDE50MGTABLET / ORALAB1999-05-2679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075274-001NALTREXONE HYDROCHLORIDE50MGTABLET / ORALAB1999-05-26301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075274-001NALTREXONE HYDROCHLORIDE50MGTABLET / ORALAB1999-05-261e350fbaab3a…
2024-05-31 18:47 UTC2024-05A075274-001NALTREXONE HYDROCHLORIDE50MGTABLET / ORALAB1999-05-268072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A075274-001NALTREXONE HYDROCHLORIDE50MGTABLET / ORALAB1999-05-265c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A075274-001NALTREXONE HYDROCHLORIDE50MGTABLET / ORALAB1999-05-265d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A075274-001NALTREXONE HYDROCHLORIDE50MGTABLET / ORALAB1999-05-264b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A075274-001NALTREXONE HYDROCHLORIDE50MGTABLET / ORALAB1999-05-2674a2ff9319b5…
2022-03-09 01:35 UTC2022-03A075274-001NALTREXONE HYDROCHLORIDE50MGTABLET / ORALAB1999-05-26bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A075274-001NALTREXONE HYDROCHLORIDE50MGTABLET / ORALAB1999-05-26782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A075274-001NALTREXONE HYDROCHLORIDE50MGTABLET / ORALAB1999-05-2687673890dc5c…
2021-03-12 10:30 UTC2021-03A075274-001NALTREXONE HYDROCHLORIDE50MGTABLET / ORALAB1999-05-265aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A075274-001NALTREXONE HYDROCHLORIDE50MGTABLET / ORALAB1999-05-268869cabd3fbd…
2020-11-12 02:37 UTC2020-11A075274-001NALTREXONE HYDROCHLORIDE50MGTABLET / ORALAB1999-05-26c0c555d07b60…
2019-12-14 00:12 UTC2019-12A075274-001NALTREXONE HYDROCHLORIDE50MGTABLET / ORALAB1999-05-263f01610625f2…
2019-09-15 20:21 UTC2019-09A075274-001NALTREXONE HYDROCHLORIDE50MGTABLET / ORALAB1999-05-26b00525d2431f…
2019-07-19 19:46 UTC2019-07A075274-001NALTREXONE HYDROCHLORIDE50MGTABLET / ORALAB1999-05-26ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A075274-001NALTREXONE HYDROCHLORIDE50MGTABLET / ORALAB1999-05-266a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A075274-001NALTREXONE HYDROCHLORIDE50MGTABLET / ORALAB1999-05-261c564ffb4f44…
2023-12-20 04:57 UTC2023-12A075274-001NALTREXONE HYDROCHLORIDE50MGTABLET / ORALAB1999-05-26ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A075274-001NALTREXONE HYDROCHLORIDE50MGTABLET / ORALAB1999-05-26a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A075274-001NALTREXONE HYDROCHLORIDE50MGTABLET / ORALAB1999-05-269b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A075274-001NALTREXONE HYDROCHLORIDE50MGTABLET / ORALAB1999-05-26a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A075274-001NALTREXONE HYDROCHLORIDE50MGTABLET / ORALAB1999-05-263f0d92c62455…
2023-05-13 08:27 UTC2023-05A075274-001NALTREXONE HYDROCHLORIDE50MGTABLET / ORALAB1999-05-26053a50430f4f…
2023-01-26 05:58 UTC2023-01A075274-001NALTREXONE HYDROCHLORIDE50MGTABLET / ORALAB1999-05-263bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A075274-001NALTREXONE HYDROCHLORIDE50MGTABLET / ORALAB1999-05-263a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A075274-001NALTREXONE HYDROCHLORIDE50MGTABLET / ORALAB1999-05-26f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A075274-001NALTREXONE HYDROCHLORIDE50MGTABLET / ORALAB1999-05-26e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A075274-001NALTREXONE HYDROCHLORIDE50MGTABLET / ORALAB1999-05-26cb3db0bc1861…

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 UTC2026-02A075274-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075274-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A075274-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075274-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075274-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075274-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075274-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075274-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075274-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A075274-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075274-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075274-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075274-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A075274-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A075274-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A075274-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A075274-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A075274-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A075274-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A075274-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A075274-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A075274-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A075274-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A075274-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A075274-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A075274-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A075274-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A075274-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A075274-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A075274-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A075274-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A075274-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A075274-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A075274-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A075274-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A075274-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A075274-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A075274-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A075274-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A075274-001AB1cb3db0bc1861…

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
b5d0b9d2-8d98-4800-855e-7e8054eadf68Available 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
71335-3012-1Naltrexone Hydrochloride100 in 1 BOTTLETABLET, FILM COATED100100

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-3012-1EA - Each71335-30120dc1e4a8-8621-4eb2-8a62-28aca2ddd71e12026-01-08

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 · 23 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Naltrexone HydrochlorideNALTREXONE HYDROCHLORIDECoupler LLC56055980-d23b-ec7d-e063-6394a90a9cc22026-05-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075274
application number: ANDA075274
Naltrexone HydrochlorideNALTREXONE HYDROCHLORIDEElite Laboratories, Inc.5f188bdc-2009-43aa-ad32-f06dbfac26422026-05-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075274
application number: ANDA075274
Naltrexone HydrochlorideNALTREXONE HYDROCHLORIDEBryant Ranch Prepackab5b3829-96e5-4123-967a-29b41f13a4f72026-04-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075274
application number: ANDA075274
Naltrexone HydrochlorideNALTREXONE HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLC4f720879-1772-e734-e063-6394a90a0cf42026-04-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075274
application number: ANDA075274
Naltrexone HydrochlorideNALTREXONE HYDROCHLORIDEBryant Ranch Prepackd8433c5e-deb3-4f20-aaf6-9fed6bc449742026-03-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075274
application number: ANDA075274
Naltrexone HydrochlorideNALTREXONE HYDROCHLORIDEBryant Ranch Prepack7976b328-ad8e-4208-9f61-19cd5ab5f36b2026-03-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075274
application number: ANDA075274
Naltrexone HydrochlorideNALTREXONE HYDROCHLORIDEBryant Ranch Prepackb773726e-1dc9-415a-81f3-32b43b61b9b12026-03-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075274
application number: ANDA075274
Naltrexone HydrochlorideNALTREXONE HYDROCHLORIDEAvKARE21b43dab-015c-c82f-ba6e-27da0ec12fc52026-02-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075274
application number: ANDA075274
Naltrexone HydrochlorideNALTREXONE HYDROCHLORIDEBryant Ranch Prepacka328c3e1-9132-491d-ae5b-45fd27ca49932025-12-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075274
application number: ANDA075274
Naltrexone HydrochlorideNALTREXONE HYDROCHLORIDEBryant Ranch Prepackd4d0537b-113a-4e49-bb50-bf5ddafe6b7d2025-12-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075274
application number: ANDA075274
Naltrexone HydrochlorideNALTREXONE HYDROCHLORIDEBryant Ranch Prepack8f019ac1-13a8-42f2-bdb2-8aaef5896d962025-11-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075274
application number: ANDA075274
Naltrexone HydrochlorideNALTREXONE HYDROCHLORIDEBryant Ranch Prepackb5d0b9d2-8d98-4800-855e-7e8054eadf682025-11-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075274
application number: ANDA075274
ndc (product): 71335-3012
Naltrexone HydrochlorideNALTREXONE HYDROCHLORIDETAGI Pharma Inc.60276f5c-657a-4b60-bcd0-44234903d7e02025-11-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075274
application number: ANDA075274
Naltrexone HydrochlorideNALTREXONE HYDROCHLORIDEPrecision Dose Inc.b09b4b5e-795a-48e7-b7cc-2e29f41c56602025-11-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075274
application number: ANDA075274
Naltrexone HydrochlorideNALTREXONE HYDROCHLORIDEREMEDYREPACK INC.db911559-26f5-43a0-b61f-3425176c936f2025-10-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075274
application number: ANDA075274
Naltrexone HydrochlorideNALTREXONE HYDROCHLORIDEBryant Ranch Prepack637ed3da-476d-4f95-8bbc-f93eaa0aa57e2025-09-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075274
application number: ANDA075274
Naltrexone HydrochlorideNALTREXONE HYDROCHLORIDEBryant Ranch Prepack68cb0399-ca56-4310-8531-6b5552b71b252025-07-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075274
application number: ANDA075274
Naltrexone HydrochlorideNALTREXONE HYDROCHLORIDEBryant Ranch Prepackd7ba0156-6222-4619-a043-b5a1342d53752025-07-28Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075274
application number: ANDA075274
Naltrexone HydrochlorideNALTREXONE HYDROCHLORIDEPrecision Dose Inc.74087d2f-468d-4de1-a2fc-a489d0f2abef2025-07-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075274
application number: ANDA075274
Naltrexone HydrochlorideNALTREXONE HYDROCHLORIDENuCare Pharmaceuticals Inc.1e059495-5e64-0cb0-e063-6394a90a3ffc2024-12-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075274
application number: ANDA075274

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1483744naltrexone HCl 50 MG Oral TabletPSNb5d0b9d2-8d98-4800-855e-7e8054eadf68100
1483744naltrexone hydrochloride 50 MG Oral TabletSCDb5d0b9d2-8d98-4800-855e-7e8054eadf68100

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
71335-3012-171335301201100 TABLET, FILM COATED in 1 BOTTLE (71335-3012-1) 2025-11-18NoNoCurrent