Methadone Hydrochloride

Product NDC
67877-659
Requested package NDC
67877-659-01
11-digit product format
678770659
Labeler code
67877
Product ID
67877-659_46a9128b-1b83-461f-83b7-75646d009fa7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Methadone Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Ascend Laboratories, LLC
Application
ANDA090635
Marketing category
ANDA
Marketing start
2025-07-01
Substance
METHADONE HYDROCHLORIDE
Active strength
5 mg/1
Pharmacologic classes
Full Opioid Agonists [MoA], Opioid Agonist [EPC]
DEA schedule
CII
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage67877-65967877-659-01DDiscontinued by firm2026-08-17

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 · 23 matching rows.

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

Captured / source date, Code, Status table
Captured / source dateCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31DDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28DDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21DDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10DDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31IInactivated by FDA302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31DDiscontinued by firm302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20IInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20DDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10IInactivated by FDA0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10DDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08IInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08DDiscontinued by firmad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03IInactivated by FDA367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03DDiscontinued by firm367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09DDiscontinued by firm557ba5c1ecfa…9c80585c8c6e…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A090635-001METHADONE HYDROCHLORIDEMETHADONE HYDROCHLORIDE10MGTABLET / ORALAA2009-11-25
A090635-002METHADONE HYDROCHLORIDEMETHADONE HYDROCHLORIDE5MGTABLET / ORALAA2020-09-22

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A090635-001AA
A090635-002AA

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 · 80 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A090635-001METHADONE HYDROCHLORIDE10MGTABLET / ORALAA2009-11-25caaa826d4ba7…
2026-08-18 06:07:402026-07A090635-002METHADONE HYDROCHLORIDE5MGTABLET / ORALAA2020-09-22caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A090635-001METHADONE HYDROCHLORIDE10MGTABLET / ORALAA2009-11-25011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090635-002METHADONE HYDROCHLORIDE5MGTABLET / ORALAA2020-09-22011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090635-001METHADONE HYDROCHLORIDE10MGTABLET / ORALAA2009-11-2531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090635-002METHADONE HYDROCHLORIDE5MGTABLET / ORALAA2020-09-2231067a03dcf5…
2025-08-23 18:47 UTC2025-08A090635-001METHADONE HYDROCHLORIDE10MGTABLET / ORALAA2009-11-256a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090635-002METHADONE HYDROCHLORIDE5MGTABLET / ORALAA2020-09-226a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090635-001METHADONE HYDROCHLORIDE10MGTABLET / ORALAA2009-11-25fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090635-002METHADONE HYDROCHLORIDE5MGTABLET / ORALAA2020-09-22fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090635-001METHADONE HYDROCHLORIDE10MGTABLET / ORALAA2009-11-25b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090635-002METHADONE HYDROCHLORIDE5MGTABLET / ORALAA2020-09-22b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090635-001METHADONE HYDROCHLORIDE10MGTABLET / ORALAA2009-11-2503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090635-002METHADONE HYDROCHLORIDE5MGTABLET / ORALAA2020-09-2203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090635-001METHADONE HYDROCHLORIDE10MGTABLET / ORALAA2009-11-252680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090635-002METHADONE HYDROCHLORIDE5MGTABLET / ORALAA2020-09-222680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090635-001METHADONE HYDROCHLORIDE10MGTABLET / ORALAA2009-11-255bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090635-002METHADONE HYDROCHLORIDE5MGTABLET / ORALAA2020-09-225bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090635-001METHADONE HYDROCHLORIDE10MGTABLET / ORALAA2009-11-25d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090635-002METHADONE HYDROCHLORIDE5MGTABLET / ORALAA2020-09-22d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090635-001METHADONE HYDROCHLORIDE10MGTABLET / ORALAA2009-11-25d06236e962d9…
2024-10-29 15:01 UTC2024-10A090635-002METHADONE HYDROCHLORIDE5MGTABLET / ORALAA2020-09-22d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090635-001METHADONE HYDROCHLORIDE10MGTABLET / ORALAA2009-11-2579d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090635-002METHADONE HYDROCHLORIDE5MGTABLET / ORALAA2020-09-2279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090635-001METHADONE HYDROCHLORIDE10MGTABLET / ORALAA2009-11-25301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090635-002METHADONE HYDROCHLORIDE5MGTABLET / ORALAA2020-09-22301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090635-001METHADONE HYDROCHLORIDE10MGTABLET / ORALAA2009-11-251e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090635-002METHADONE HYDROCHLORIDE5MGTABLET / ORALAA2020-09-221e350fbaab3a…
2024-05-31 18:47 UTC2024-05A090635-001METHADONE HYDROCHLORIDE10MGTABLET / ORALAA2009-11-258072bd15b7f6…
2024-05-31 18:47 UTC2024-05A090635-002METHADONE HYDROCHLORIDE5MGTABLET / ORALAA2020-09-228072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090635-001METHADONE HYDROCHLORIDE10MGTABLET / ORALAA2009-11-255c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090635-002METHADONE HYDROCHLORIDE5MGTABLET / ORALAA2020-09-225c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A090635-001METHADONE HYDROCHLORIDE10MGTABLET / ORALAA2009-11-255d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A090635-002METHADONE HYDROCHLORIDE5MGTABLET / ORALAA2020-09-225d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A090635-001METHADONE HYDROCHLORIDE10MGTABLET / ORALAA2009-11-254b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A090635-002METHADONE HYDROCHLORIDE5MGTABLET / ORALAA2020-09-224b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A090635-001METHADONE HYDROCHLORIDE10MGTABLET / ORALAA2009-11-2574a2ff9319b5…
2022-03-09 01:35 UTC2022-03A090635-001METHADONE HYDROCHLORIDE10MGTABLET / ORALAA2009-11-25bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A090635-002METHADONE HYDROCHLORIDE5MGTABLET / ORALAA2020-09-22bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A090635-001METHADONE HYDROCHLORIDE10MGTABLET / ORALAA2009-11-25782e0a99824c…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 80 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A090635-001AA1caaa826d4ba7…
2026-08-18 06:07:402026-07A090635-002AA1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A090635-001AA1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090635-002AA1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090635-001AA131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090635-002AA131067a03dcf5…
2025-08-23 18:47 UTC2025-08A090635-001AA16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090635-002AA16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090635-001AA1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090635-002AA1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090635-001AA1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090635-002AA1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090635-001AA103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090635-002AA103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090635-001AA12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090635-002AA12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090635-001AA15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090635-002AA15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090635-001AA1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090635-002AA1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090635-001AA1d06236e962d9…
2024-10-29 15:01 UTC2024-10A090635-002AA1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090635-001AA179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090635-002AA179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090635-001AA1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090635-002AA1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090635-001AA11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090635-002AA11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A090635-001AA18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A090635-002AA18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090635-001AA15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090635-002AA15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A090635-001AA15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A090635-002AA15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A090635-001AA14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A090635-002AA14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A090635-001AA174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A090635-001AA1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A090635-002AA1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A090635-001AA1782e0a99824c…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
METHADONE HYDROCHLORIDE5 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
229809935BInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
864706Internal RxNorm lookup
864718Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
f0366917-f745-4b01-a662-a98a7d80b4a0Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bc6c52c8-e3e2-9042-21d0-6770dcf1a49bProduct name320250819
a48f0261-b6cc-12b3-49fd-ed131bc5aa96Product name420210902
00dcb24c-d95e-78f6-6c1b-4d7b709bb2b9Product name620200708
a6a96832-f31d-b458-45cb-abb8bd940b44Product name220200304

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67877-659-01Methadone Hydrochloride100 in 1 BOTTLETABLET1004

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
67877-659-01EA - Each67877-6599d5d0067-1c33-401a-8a26-3010721184a512022-09-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67877-659METHADONE HYDROCHLORIDE TABLET [ASCEND LABORATORIES, LLC]1Current NDC, Legacy NDC, 1 package rows20220819_f0366917-f745-4b01-a662-a98a7d80b4a0.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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Methadone HydrochlorideMETHADONE HYDROCHLORIDEAscend Laboratories, LLCf0366917-f745-4b01-a662-a98a7d80b4a02026-04-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090635
application number: ANDA090635
ndc (package): 67877-659-01
ndc (product): 67877-659
ndc11 (package): 67877065901
METHADONE HYDROCHLORIDEMETHADONE HYDROCHLORIDEBryant Ranch Prepack7a8635fe-6183-4cda-9029-50e4e6dd58322023-11-06Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090635
application number: ANDA090635

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
864706methadone HCl 10 MG Oral TabletPSNf0366917-f745-4b01-a662-a98a7d80b4a04
864718methadone HCl 5 MG Oral TabletPSNf0366917-f745-4b01-a662-a98a7d80b4a04
864706methadone hydrochloride 10 MG Oral TabletSCDf0366917-f745-4b01-a662-a98a7d80b4a04
864718methadone hydrochloride 5 MG Oral TabletSCDf0366917-f745-4b01-a662-a98a7d80b4a04

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67877-659-0167877065901100 TABLET in 1 BOTTLE (67877-659-01) 100 tablet2025-07-010000-00-00NoNoCurrent