FDA.reportPublic FDA data

METHADONE HYDROCHLORIDE

Product NDC
0054-0709
11-digit product format
000540709
Labeler code
0054
Product ID
0054-0709_32014633-5c89-4163-9fa7-239777c04d1d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
METHADONE HYDROCHLORIDE
Dosage form
TABLET
Route
ORAL
Labeler
Hikma Pharmaceuticals USA Inc.
Application
ANDA088109
Marketing category
ANDA
Marketing start
1983-03-08
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 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct0054-0709DDiscontinued by firm2026-08-17
excluded packagepackage0054-07090054-0709-20DDiscontinued by firm2026-08-17
excluded packagepackage0054-07090054-0709-25DDiscontinued 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 · 36 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0054-0709-20d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0054-0709-25d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0054-0709-20f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0054-0709-25f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0054-0709-202ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0054-0709-252ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0054-0709-20a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0054-0709-25a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0054-0709-20cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0054-0709-25cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0054-0709-20cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0054-0709-25cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0054-0709-20302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0054-0709-25302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0054-0709-20ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0054-0709-25ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0054-0709-200efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0054-0709-250efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0054-0709-20ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0054-0709-25ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0054-0709-20367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0054-0709-25367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0054-0709-20557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0054-0709-25557ba5c1ecfa…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
A088109-001METHADONE HYDROCHLORIDEMETHADONE HYDROCHLORIDE10MGTABLET / ORALAA1983-03-08
A088109-002METHADONE HYDROCHLORIDEMETHADONE HYDROCHLORIDE5MGTABLET / ORALAA1983-03-08

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A088109-001AA
A088109-002AA

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 · 47 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A088109-001METHADONE HYDROCHLORIDE10MGTABLET / ORALAA1983-03-08caaa826d4ba7…
2026-08-18 06:07:402026-07A088109-002METHADONE HYDROCHLORIDE5MGTABLET / ORALAA1983-03-08caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A088109-001METHADONE HYDROCHLORIDE10MGTABLET / ORALAA1983-03-08011fe1cb6892…
2026-02-19 14:30 UTC2026-02A088109-002METHADONE HYDROCHLORIDE5MGTABLET / ORALAA1983-03-08011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A088109-001METHADONE HYDROCHLORIDE10MGTABLET / ORALAA1983-03-0831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A088109-002METHADONE HYDROCHLORIDE5MGTABLET / ORALAA1983-03-0831067a03dcf5…
2025-08-23 18:47 UTC2025-08A088109-001METHADONE HYDROCHLORIDE10MGTABLET / ORALAA1983-03-086a471c1ec25d…
2025-08-23 18:47 UTC2025-08A088109-002METHADONE HYDROCHLORIDE5MGTABLET / ORALAA1983-03-086a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A088109-001METHADONE HYDROCHLORIDE10MGTABLET / ORALAA1983-03-08fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A088109-001METHADONE HYDROCHLORIDE10MGTABLET / ORALAA1983-03-08b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A088109-001METHADONE HYDROCHLORIDE10MGTABLET / ORALAA1983-03-0803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A088109-001METHADONE HYDROCHLORIDE10MGTABLET / ORALAA1983-03-082680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A088109-001METHADONE HYDROCHLORIDE10MGTABLET / ORALAA1983-03-085bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A088109-001METHADONE HYDROCHLORIDE10MGTABLET / ORALAA1983-03-08d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A088109-001METHADONE HYDROCHLORIDE10MGTABLET / ORALAA1983-03-08d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A088109-001METHADONE HYDROCHLORIDE10MGTABLET / ORALAA1983-03-0879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A088109-001METHADONE HYDROCHLORIDE10MGTABLET / ORALAA1983-03-08301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A088109-001METHADONE HYDROCHLORIDE10MGTABLET / ORALAA1983-03-081e350fbaab3a…
2024-05-31 18:47 UTC2024-05A088109-001METHADONE HYDROCHLORIDE10MGTABLET / ORALAA1983-03-088072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A088109-001METHADONE HYDROCHLORIDE10MGTABLET / ORALAA1983-03-085c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A088109-001METHADONE HYDROCHLORIDE10MGTABLET / ORALAA1983-03-085d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A088109-001METHADONE HYDROCHLORIDE10MGTABLET / ORALAA1983-03-084b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A088109-001METHADONE HYDROCHLORIDE10MGTABLET / ORAL1983-03-0874a2ff9319b5…
2022-03-09 01:35 UTC2022-03A088109-001METHADONE HYDROCHLORIDE10MGTABLET / ORALAA1983-03-08bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A088109-001METHADONE HYDROCHLORIDE10MGTABLET / ORALAA1983-03-08782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A088109-001METHADONE HYDROCHLORIDE10MGTABLET / ORALAA1983-03-0887673890dc5c…
2021-03-12 10:30 UTC2021-03A088109-001METHADONE HYDROCHLORIDE10MGTABLET / ORALAA1983-03-085aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A088109-001METHADONE HYDROCHLORIDE10MGTABLET / ORALAA1983-03-088869cabd3fbd…
2020-11-12 02:37 UTC2020-11A088109-001METHADONE HYDROCHLORIDE10MGTABLET / ORALAA1983-03-08c0c555d07b60…
2019-12-14 00:12 UTC2019-12A088109-001METHADONE HYDROCHLORIDE10MGTABLET / ORAL1983-03-083f01610625f2…
2019-09-15 20:21 UTC2019-09A088109-001METHADONE HYDROCHLORIDE10MGTABLET / ORAL1983-03-08b00525d2431f…
2019-07-19 19:46 UTC2019-07A088109-001METHADONE HYDROCHLORIDE10MGTABLET / ORAL1983-03-08ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A088109-001METHADONE HYDROCHLORIDE10MGTABLET / ORALAA1983-03-086a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A088109-001METHADONE HYDROCHLORIDE10MGTABLET / ORALAA1983-03-081c564ffb4f44…
2023-12-20 04:57 UTC2023-12A088109-001METHADONE HYDROCHLORIDE10MGTABLET / ORALAA1983-03-08ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A088109-001METHADONE HYDROCHLORIDE10MGTABLET / ORALAA1983-03-08a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A088109-001METHADONE HYDROCHLORIDE10MGTABLET / ORALAA1983-03-089b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A088109-001METHADONE HYDROCHLORIDE10MGTABLET / ORALAA1983-03-08a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A088109-001METHADONE HYDROCHLORIDE10MGTABLET / ORALAA1983-03-083f0d92c62455…
2023-05-13 08:27 UTC2023-05A088109-001METHADONE HYDROCHLORIDE10MGTABLET / ORALAA1983-03-08053a50430f4f…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A088109-001AA1caaa826d4ba7…
2026-08-18 06:07:402026-07A088109-002AA1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A088109-001AA1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A088109-002AA1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A088109-001AA131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A088109-002AA131067a03dcf5…
2025-08-23 18:47 UTC2025-08A088109-001AA16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A088109-002AA16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A088109-001AA1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A088109-001AA1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A088109-001AA103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A088109-001AA12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A088109-001AA15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A088109-001AA1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A088109-001AA1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A088109-001AA179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A088109-001AA1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A088109-001AA11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A088109-001AA18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A088109-001AA15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A088109-001AA15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A088109-001AA14b0b4de00fa7…
2022-03-09 01:35 UTC2022-03A088109-001AA1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A088109-001AA1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A088109-001AA187673890dc5c…
2021-03-12 10:30 UTC2021-03A088109-001AA15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A088109-001AA18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A088109-001AA1c0c555d07b60…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A088109-001AA16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A088109-001AA11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A088109-001AA1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A088109-001AA1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A088109-001AA19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A088109-001AA1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A088109-001AA13f0d92c62455…
2023-05-13 08:27 UTC2023-05A088109-001AA1053a50430f4f…
2023-01-26 05:58 UTC2023-01A088109-001AA13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A088109-001AA13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A088109-001AA1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A088109-001AA1e64feba35796…

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
50f14803-78c0-4d19-8b5d-9a9c17582ac1Available 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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0054-0709-20METHADONE HYDROCHLORIDE1 in 1 CARTONTABLET19
0054-0709-20METHADONE HYDROCHLORIDE100 in 1 BLISTER PACKTABLET1009
0054-0709-25METHADONE HYDROCHLORIDE100 in 1 BOTTLE, PLASTICTABLET1009

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0054-0709-20EA - Each0054-07092d224c2b-e99c-49a4-b35f-8f55b59bd57e12021-02-05
0054-0709-25EA - Each0054-070940b47aed-82bd-4fc2-b569-e2c87621feb612021-02-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0054-0709METHADONE HYDROCHLORIDE TABLET [HIKMA PHARMACEUTICALS USA INC.]5Current NDC, Legacy NDC, 3 package rows20250202_50f14803-78c0-4d19-8b5d-9a9c17582ac1.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 HYDROCHLORIDEMajor Pharmaceuticalsdb52fdc0-765a-4fad-a8f9-ef98c6e4b8982026-07-16Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 088109
application number: ANDA088109
METHADONE HYDROCHLORIDEMETHADONE HYDROCHLORIDEHikma Pharmaceuticals USA Inc.50f14803-78c0-4d19-8b5d-9a9c17582ac12025-10-31Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 088109
application number: ANDA088109
ndc (product): 0054-0709

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
864706methadone HCl 10 MG Oral TabletPSN50f14803-78c0-4d19-8b5d-9a9c17582ac19
864718methadone HCl 5 MG Oral TabletPSN50f14803-78c0-4d19-8b5d-9a9c17582ac19
864706methadone hydrochloride 10 MG Oral TabletSCD50f14803-78c0-4d19-8b5d-9a9c17582ac19
864718methadone hydrochloride 5 MG Oral TabletSCD50f14803-78c0-4d19-8b5d-9a9c17582ac19

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0054-0709-20000540709201 BLISTER PACK in 1 CARTON (0054-0709-20) / 100 TABLET in 1 BLISTER PACK1 blister pack1983-03-080000-00-00NoNoCurrent
0054-0709-2500054070925100 TABLET in 1 BOTTLE, PLASTIC (0054-0709-25) 100 tablet1983-03-080000-00-00NoNoCurrent