Naltrexone

Product NDC
69238-2794
11-digit product format
692382794
Labeler code
69238
Product ID
69238-2794_eb09c632-ad0b-4dc9-b7a6-3189ba25f77e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Naltrexone
Dosage form
KIT
Labeler
Amneal Pharmaceuticals NY LLC
Application
NDA021897
Marketing category
NDA
Marketing start
2026-05-01
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

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
N021897-001VIVITROLNALTREXONE380MG/VIALFOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULARRLD, RS2006-04-13

Orange Book patents#

Current patent rows page 1 of 1 · 2 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N021897-00179194992029-10-15U-11232011-05-16
N021897-00179194992029-10-15U-11242011-05-16

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 06:07:402026-07N021897-001VIVITROL380MG/VIALFOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULARRLD, RS2006-04-13caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N021897-001VIVITROL380MG/VIALFOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULARRLD, RS2006-04-13011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021897-001VIVITROL380MG/VIALFOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULARRLD, RS2006-04-1331067a03dcf5…
2025-08-23 18:47 UTC2025-08N021897-001VIVITROL380MG/VIALFOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULARRLD, RS2006-04-136a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021897-001VIVITROL380MG/VIALFOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULARRLD, RS2006-04-13fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021897-001VIVITROL380MG/VIALFOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULARRLD, RS2006-04-13b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021897-001VIVITROL380MG/VIALFOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULARRLD, RS2006-04-1303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021897-001VIVITROL380MG/VIALFOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULARRLD, RS2006-04-132680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021897-001VIVITROL380MG/VIALFOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULARRLD, RS2006-04-135bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021897-001VIVITROL380MG/VIALFOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULARRLD, RS2006-04-13d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N021897-001VIVITROL380MG/VIALFOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULARRLD, RS2006-04-13d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021897-001VIVITROL380MG/VIALFOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULARRLD, RS2006-04-1379d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021897-001VIVITROL380MG/VIALFOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULARRLD, RS2006-04-13301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021897-001VIVITROL380MG/VIALFOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULARRLD, RS2006-04-131e350fbaab3a…
2024-05-31 18:47 UTC2024-05N021897-001VIVITROL380MG/VIALFOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULARRLD, RS2006-04-138072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021897-001VIVITROL380MG/VIALFOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULARRLD, RS2006-04-135c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N021897-001VIVITROL380MG/VIALFOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULARRLD, RS2006-04-135d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N021897-001VIVITROL380MG/VIALFOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULARRLD, RS2006-04-134b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N021897-001VIVITROL380MG/VIALFOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULARRLD, RS2006-04-1374a2ff9319b5…
2022-03-09 01:35 UTC2022-03N021897-001VIVITROL380MG/VIALFOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULARRLD, RS2006-04-13bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N021897-001VIVITROL380MG/VIALFOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULARRLD, RS2006-04-13782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N021897-001VIVITROL380MG/VIALFOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULARRLD, RS2006-04-1387673890dc5c…
2021-03-12 10:30 UTC2021-03N021897-001VIVITROL380MG/VIALFOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULARRLD, RS2006-04-135aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N021897-001VIVITROL380MG/VIALFOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULARRLD, RS2006-04-138869cabd3fbd…
2020-11-12 02:37 UTC2020-11N021897-001VIVITROL380MG/VIALFOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULARRLD, RS2006-04-13c0c555d07b60…
2019-12-14 00:12 UTC2019-12N021897-001VIVITROL380MG/VIALFOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULARRLD, RS2006-04-133f01610625f2…
2019-09-15 20:21 UTC2019-09N021897-001VIVITROL380MG/VIALFOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULARRLD, RS2006-04-13b00525d2431f…
2019-07-19 19:46 UTC2019-07N021897-001VIVITROL380MG/VIALFOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULARRLD, RS2006-04-13ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N021897-001VIVITROL380MG/VIALFOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULARRLD, RS2006-04-136a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N021897-001VIVITROL380MG/VIALFOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULARRLD, RS2006-04-131c564ffb4f44…
2023-12-20 04:57 UTC2023-12N021897-001VIVITROL380MG/VIALFOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULARAPRLD, RS2006-04-13ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N021897-001VIVITROL380MG/VIALFOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULARAPRLD, RS2006-04-13a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N021897-001VIVITROL380MG/VIALFOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULARAPRLD, RS2006-04-139b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N021897-001VIVITROL380MG/VIALFOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULARAPRLD, RS2006-04-13a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N021897-001VIVITROL380MG/VIALFOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULARRLD, RS2006-04-133f0d92c62455…
2023-05-13 08:27 UTC2023-05N021897-001VIVITROL380MG/VIALFOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULARRLD, RS2006-04-13053a50430f4f…
2023-01-26 05:58 UTC2023-01N021897-001VIVITROL380MG/VIALFOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULARRLD, RS2006-04-133bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N021897-001VIVITROL380MG/VIALFOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULARRLD, RS2006-04-133a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N021897-001VIVITROL380MG/VIALFOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULARRLD, RS2006-04-13f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N021897-001VIVITROL380MG/VIALFOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULARRLD, RS2006-04-13e64feba35796…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2023-12-20 04:57 UTC2023-12N021897-001AP1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N021897-001AP1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N021897-001AP19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N021897-001AP1a67488948f0b…

Observed Orange Book patent history#

Patent history page 1 of 4 · 144 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-08-18 06:07:402026-07N021897-00179194992029-10-15U-11242011-05-16caaa826d4ba7…
2026-08-18 06:07:402026-07N021897-00179194992029-10-15U-11232011-05-16caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N021897-00179194992029-10-15U-11242011-05-16011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021897-00179194992029-10-15U-11232011-05-16011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021897-00179194992029-10-15U-11242011-05-1631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021897-00179194992029-10-15U-11232011-05-1631067a03dcf5…
2025-08-23 18:47 UTC2025-08N021897-00179194992029-10-15U-11242011-05-166a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021897-00179194992029-10-15U-11232011-05-166a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021897-00179194992029-10-15U-11242011-05-16fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021897-00179194992029-10-15U-11232011-05-16fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021897-00179194992029-10-15U-11242011-05-16b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021897-00179194992029-10-15U-11232011-05-16b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021897-00179194992029-10-15U-11242011-05-1603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021897-00179194992029-10-15U-11232011-05-1603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021897-00179194992029-10-15U-11242011-05-162680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021897-00179194992029-10-15U-11232011-05-162680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021897-00179194992029-10-15U-11242011-05-165bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021897-00179194992029-10-15U-11232011-05-165bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021897-00179194992029-10-15U-11242011-05-16d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021897-00179194992029-10-15U-11232011-05-16d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N021897-00179194992029-10-15U-11242011-05-16d06236e962d9…
2024-10-29 15:01 UTC2024-10N021897-00179194992029-10-15U-11232011-05-16d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021897-00179194992029-10-15U-11242011-05-1679d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021897-00179194992029-10-15U-11232011-05-1679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021897-00179194992029-10-15U-11242011-05-16301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021897-00179194992029-10-15U-11232011-05-16301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021897-00179194992029-10-15U-11242011-05-161e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021897-00179194992029-10-15U-11232011-05-161e350fbaab3a…
2024-05-31 18:47 UTC2024-05N021897-00179194992029-10-15U-11242011-05-168072bd15b7f6…
2024-05-31 18:47 UTC2024-05N021897-00179194992029-10-15U-11232011-05-168072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021897-00179194992029-10-15U-11242011-05-165c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021897-00179194992029-10-15U-11232011-05-165c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N021897-00179194992029-10-15U-11242011-05-165d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N021897-00179194992029-10-15U-11232011-05-165d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N021897-00179194992029-10-15U-11242011-05-164b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N021897-00179194992029-10-15U-11232011-05-164b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N021897-00163313172019-11-12Drug product74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021897-00163953042019-11-12Drug product74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021897-00164951662019-11-12Drug product74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021897-00165375862019-11-12Drug product74a2ff9319b5…

Additional Listing Data#

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

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
637213Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
6de5637f-d527-4228-af1a-3aae71155cb5Available 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
69238-2792-1Naltrexone5 mL in 1 VIAL, GLASSINJECTION, POWDER, FOR SUSPENSIO5 mL380 mg in 5mL1
69238-2794-1Naltrexone1 in 1 CARTONKIT11

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
VIVITROLNALTREXONEAlkermes, Inc.cd11c435-b0f0-4bb9-ae78-60f101f3703f2026-05-31Warnings, Adverse reactionsExact identifier
application applno (NDA): 021897
application number: NDA021897
NaltrexoneNALTREXONEAmneal Pharmaceuticals NY LLC6de5637f-d527-4228-af1a-3aae71155cb52026-01-30Warnings, Adverse reactionsExact identifier
application applno (NDA): 021897
application number: NDA021897
ndc (product): 69238-2794

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
637213naltrexone 380 MG InjectionPSN6de5637f-d527-4228-af1a-3aae71155cb51
637213naltrexone 380 MG InjectionSCD6de5637f-d527-4228-af1a-3aae71155cb51

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
69238-2792-1692382792015 mL in 1 VIAL, GLASS5 mlHistorical
69238-2794-1692382794011 KIT in 1 CARTON (69238-2794-1) * 5 mL in 1 VIAL, GLASS (69238-2792-1) * 4 mL in 1 VIAL, GLASS (69238-2793-1) 1 kit2026-05-01NoNoCurrent