Naltrexone Hydrochloride

Product NDC
63629-1047
11-digit product format
636291047
Labeler code
63629
Product ID
63629-1047_af911c60-0d5d-461d-b494-78281e9d8751
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
2013-09-23
Marketing end
2027-11-30
Substance
NALTREXONE HYDROCHLORIDE
Active strength
50 mg/1
Pharmacologic classes
Opioid Antagonist [EPC], Opioid Antagonists [MoA]
NDC exclude flag
No
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…

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 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
ndc (product): 63629-1047
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
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

Additional Listing Data#

Finished product
Yes
Brand name base
Naltrexone Hydrochloride

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
b773726e-1dc9-415a-81f3-32b43b61b9b1Available 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
63629-1047-1Naltrexone Hydrochloride100 in 1 BOTTLETABLET, FILM COATED1006

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-1047-1EA - Each63629-104716b9d7b6-769c-4ae0-8b89-447723d01e3912019-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-1047NALTREXONE HYDROCHLORIDE TABLET, FILM COATED [BRYANT RANCH PREPACK]5Current NDC, Legacy NDC, 1 package rows20231019_b773726e-1dc9-415a-81f3-32b43b61b9b1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1483744naltrexone HCl 50 MG Oral TabletPSNb773726e-1dc9-415a-81f3-32b43b61b9b16
1483744naltrexone hydrochloride 50 MG Oral TabletSCDb773726e-1dc9-415a-81f3-32b43b61b9b16

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63629-1047-163629104701100 TABLET, FILM COATED in 1 BOTTLE (63629-1047-1) 2013-09-232027-11-30NoNoCurrent