Methadone Hydrochloride

Product NDC
17856-3554
11-digit product format
178563554
Labeler code
17856
Product ID
17856-3554_97bdff8b-376c-4eb5-8ee9-8e6bbd656d3c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Methadone Hydrochloride
Dosage form
SOLUTION
Route
ORAL
Labeler
ATLANTIC BIOLOGICALS CORP.
Application
ANDA087393
Marketing category
ANDA
Marketing start
2019-03-13
Marketing end
0000-00-00
Substance
METHADONE HYDROCHLORIDE
Active strength
5 mg/5mL
Pharmacologic classes
Full Opioid Agonists [MoA],Opioid Agonist [EPC]
DEA schedule
CII
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

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 · 4 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct17856-3554IInactivated by FDA2026-08-11
excluded packagepackage17856-355417856-3554-1IInactivated by FDA2026-08-11
excluded packagepackage17856-355417856-3554-2IInactivated by FDA2026-08-11
excluded packagepackage17856-355417856-3554-3IInactivated by FDA2026-08-11

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 · 8 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage17856-3554-3834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage17856-3554-2834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage17856-3554-1834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage17856-3554-31332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage17856-3554-21332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage17856-3554-11332a3947898…d4bfe170f9cd…

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
A087393-001METHADONE HYDROCHLORIDEMETHADONE HYDROCHLORIDE5MG/5MLSOLUTION / ORALAARLD, RS, Approved before 1982

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A087393-001AA

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 UTC2026-02A087393-001METHADONE HYDROCHLORIDE5MG/5MLSOLUTION / ORALAARLD, RS, Approved before 1982011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A087393-001METHADONE HYDROCHLORIDE5MG/5MLSOLUTION / ORALAARLD, RS, Approved before 198231067a03dcf5…
2025-08-23 18:47 UTC2025-08A087393-001METHADONE HYDROCHLORIDE5MG/5MLSOLUTION / ORALAARLD, RS, Approved before 19826a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A087393-001METHADONE HYDROCHLORIDE5MG/5MLSOLUTION / ORALAARLD, RS, Approved before 1982fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A087393-001METHADONE HYDROCHLORIDE5MG/5MLSOLUTION / ORALAARLD, RS, Approved before 1982b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A087393-001METHADONE HYDROCHLORIDE5MG/5MLSOLUTION / ORALAARLD, RS, Approved before 198203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A087393-001METHADONE HYDROCHLORIDE5MG/5MLSOLUTION / ORALAARLD, RS, Approved before 19822680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A087393-001METHADONE HYDROCHLORIDE5MG/5MLSOLUTION / ORALAARLD, RS, Approved before 19825bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A087393-001METHADONE HYDROCHLORIDE5MG/5MLSOLUTION / ORALAARLD, RS, Approved before 1982d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A087393-001METHADONE HYDROCHLORIDE5MG/5MLSOLUTION / ORALAARLD, RS, Approved before 1982d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A087393-001METHADONE HYDROCHLORIDE5MG/5MLSOLUTION / ORALAARLD, RS, Approved before 198279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A087393-001METHADONE HYDROCHLORIDE5MG/5MLSOLUTION / ORALAARLD, RS, Approved before 1982301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A087393-001METHADONE HYDROCHLORIDE5MG/5MLSOLUTION / ORALAARLD, RS, Approved before 19821e350fbaab3a…
2024-05-31 18:47 UTC2024-05A087393-001METHADONE HYDROCHLORIDE5MG/5MLSOLUTION / ORALAARLD, RS, Approved before 19828072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A087393-001METHADONE HYDROCHLORIDE5MG/5MLSOLUTION / ORALAARLD, RS, Approved before 19825c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A087393-001METHADONE HYDROCHLORIDE5MG/5MLSOLUTION / ORALAARLD, RS, Approved before 19825d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A087393-001METHADONE HYDROCHLORIDE5MG/5MLSOLUTION / ORALAARLD, RS, Approved before 19824b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A087393-001METHADONE HYDROCHLORIDE5MG/5MLSOLUTION / ORALAARS, Approved before 198274a2ff9319b5…
2022-03-09 01:35 UTC2022-03A087393-001METHADONE HYDROCHLORIDE5MG/5MLSOLUTION / ORALAARLD, RS, Approved before 1982bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A087393-001METHADONE HYDROCHLORIDE5MG/5MLSOLUTION / ORALAARLD, RS, Approved before 1982782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A087393-001METHADONE HYDROCHLORIDE5MG/5MLSOLUTION / ORALAARS, Approved before 198287673890dc5c…
2021-03-12 10:30 UTC2021-03A087393-001METHADONE HYDROCHLORIDE5MG/5MLSOLUTION / ORALAARS, Approved before 19825aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A087393-001METHADONE HYDROCHLORIDE5MG/5MLSOLUTION / ORALAARS, Approved before 19828869cabd3fbd…
2020-11-12 02:37 UTC2020-11A087393-001METHADONE HYDROCHLORIDE5MG/5MLSOLUTION / ORALAARS, Approved before 1982c0c555d07b60…
2019-12-14 00:12 UTC2019-12A087393-001METHADONE HYDROCHLORIDE5MG/5MLSOLUTION / ORALAARS, Approved before 19823f01610625f2…
2019-09-15 20:21 UTC2019-09A087393-001METHADONE HYDROCHLORIDE5MG/5MLSOLUTION / ORALAARS, Approved before 1982b00525d2431f…
2019-07-19 19:46 UTC2019-07A087393-001METHADONE HYDROCHLORIDE5MG/5MLSOLUTION / ORALAARS, Approved before 1982ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A087393-001METHADONE HYDROCHLORIDE5MG/5MLSOLUTION / ORALAARLD, RS, Approved before 19826a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A087393-001METHADONE HYDROCHLORIDE5MG/5MLSOLUTION / ORALAARLD, RS, Approved before 19821c564ffb4f44…
2023-12-20 04:57 UTC2023-12A087393-001METHADONE HYDROCHLORIDE5MG/5MLSOLUTION / ORALAARLD, RS, Approved before 1982ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A087393-001METHADONE HYDROCHLORIDE5MG/5MLSOLUTION / ORALAARLD, RS, Approved before 1982a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A087393-001METHADONE HYDROCHLORIDE5MG/5MLSOLUTION / ORALAARLD, RS, Approved before 19829b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A087393-001METHADONE HYDROCHLORIDE5MG/5MLSOLUTION / ORALAARLD, RS, Approved before 1982a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A087393-001METHADONE HYDROCHLORIDE5MG/5MLSOLUTION / ORALAARLD, RS, Approved before 19823f0d92c62455…
2023-05-13 08:27 UTC2023-05A087393-001METHADONE HYDROCHLORIDE5MG/5MLSOLUTION / ORALAARLD, RS, Approved before 1982053a50430f4f…
2023-01-26 05:58 UTC2023-01A087393-001METHADONE HYDROCHLORIDE5MG/5MLSOLUTION / ORALAARLD, RS, Approved before 19823bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A087393-001METHADONE HYDROCHLORIDE5MG/5MLSOLUTION / ORALAARLD, RS, Approved before 19823a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A087393-001METHADONE HYDROCHLORIDE5MG/5MLSOLUTION / ORALAARLD, RS, Approved before 1982f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A087393-001METHADONE HYDROCHLORIDE5MG/5MLSOLUTION / ORALAARLD, RS, Approved before 1982e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A087393-001METHADONE HYDROCHLORIDE5MG/5MLSOLUTION / ORALAARLD, RS, Approved before 1982cb3db0bc1861…

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 UTC2026-02A087393-001AA1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A087393-001AA131067a03dcf5…
2025-08-23 18:47 UTC2025-08A087393-001AA16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A087393-001AA1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A087393-001AA1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A087393-001AA103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A087393-001AA12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A087393-001AA15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A087393-001AA1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A087393-001AA1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A087393-001AA179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A087393-001AA1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A087393-001AA11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A087393-001AA18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A087393-001AA15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A087393-001AA15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A087393-001AA14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A087393-001AA174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A087393-001AA1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A087393-001AA1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A087393-001AA187673890dc5c…
2021-03-12 10:30 UTC2021-03A087393-001AA15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A087393-001AA18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A087393-001AA1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A087393-001AA13f01610625f2…
2019-09-15 20:21 UTC2019-09A087393-001AA1b00525d2431f…
2019-07-19 19:46 UTC2019-07A087393-001AA1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A087393-001AA16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A087393-001AA11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A087393-001AA1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A087393-001AA1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A087393-001AA19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A087393-001AA1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A087393-001AA13f0d92c62455…
2023-05-13 08:27 UTC2023-05A087393-001AA1053a50430f4f…
2023-01-26 05:58 UTC2023-01A087393-001AA13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A087393-001AA13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A087393-001AA1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A087393-001AA1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A087393-001AA1cb3db0bc1861…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bc6c52c8-e3e2-9042-21d0-6770dcf1a49bProduct name320250819
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
a48f0261-b6cc-12b3-49fd-ed131bc5aa96Product name420210902
00dcb24c-d95e-78f6-6c1b-4d7b709bb2b9Product name620200708
a6a96832-f31d-b458-45cb-abb8bd940b44Product name220200304
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
17856-3554-12024-05-20These highlights do not include all the information needed to use METHADONE HYDROCHLORIDE ORAL SOLUTION safely and effectively. See full prescribing information for METHADONE HYDROCHLORIDE ORAL SOLUTION. METHADONE HYDROCHLORIDE oral solution, for oral use, CII Initial U.S. Approval: 1947
17856-3554-22024-05-20These highlights do not include all the information needed to use METHADONE HYDROCHLORIDE ORAL SOLUTION safely and effectively. See full prescribing information for METHADONE HYDROCHLORIDE ORAL SOLUTION. METHADONE HYDROCHLORIDE oral solution, for oral use, CII Initial U.S. Approval: 1947
17856-3554-32024-05-20These highlights do not include all the information needed to use METHADONE HYDROCHLORIDE ORAL SOLUTION safely and effectively. See full prescribing information for METHADONE HYDROCHLORIDE ORAL SOLUTION. METHADONE HYDROCHLORIDE oral solution, for oral use, CII Initial U.S. Approval: 1947
17856-3554-12023-01-30These highlights do not include all the information needed to use METHADONE HYDROCHLORIDE ORAL SOLUTION safely and effectively. See full prescribing information for METHADONE HYDROCHLORIDE ORAL SOLUTION. METHADONE HYDROCHLORIDE oral solution, for oral use, CII Initial U.S. Approval: 1947
17856-3554-22023-01-30These highlights do not include all the information needed to use METHADONE HYDROCHLORIDE ORAL SOLUTION safely and effectively. See full prescribing information for METHADONE HYDROCHLORIDE ORAL SOLUTION. METHADONE HYDROCHLORIDE oral solution, for oral use, CII Initial U.S. Approval: 1947
17856-3554-32023-01-30These highlights do not include all the information needed to use METHADONE HYDROCHLORIDE ORAL SOLUTION safely and effectively. See full prescribing information for METHADONE HYDROCHLORIDE ORAL SOLUTION. METHADONE HYDROCHLORIDE oral solution, for oral use, CII Initial U.S. Approval: 1947

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
17856-3554-1Methadone Hydrochloride5 mL in 1 SYRINGESOLUTION55
17856-3554-1Methadone Hydrochloride48 in 1 BOX, UNIT-DOSESOLUTION485
17856-3554-2Methadone Hydrochloride48 in 1 BOX, UNIT-DOSESOLUTION485
17856-3554-2Methadone Hydrochloride5 mL in 1 SYRINGESOLUTION55
17856-3554-3Methadone Hydrochloride72 in 1 BOX, UNIT-DOSESOLUTION725
17856-3554-3Methadone Hydrochloride10 mL in 1 CUP, UNIT-DOSESOLUTION105

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
17856-3554METHADONE HYDROCHLORIDE SOLUTION [ATLANTIC BIOLOGICALS CORP.]5Legacy NDC, 6 package rows20240522_eff99966-a35c-4952-a9aa-1344da90b9eb.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 · 4 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Methadone HydrochlorideMETHADONE HYDROCHLORIDEHikma Pharmaceuticals USA Inc.8c363f90-c378-48ae-abbc-aeb25c9bf5cb2025-12-05Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 087393
application number: ANDA087393
Methadone HydrochlorideMETHADONE HYDROCHLORIDEPrecision Dose, Inc.cbc42334-8783-4572-b8da-8c7451d140772025-11-05Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 087393
application number: ANDA087393
Methadone HydrochlorideMETHADONE HYDROCHLORIDEAmerican Health Packagingf935effe-e5b2-4bf7-bbde-6e80bb99076f2025-05-13Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 087393
application number: ANDA087393
Methadone HydrochlorideMETHADONE HYDROCHLORIDEPrecision Dose, Inc.e980d666-d74d-4358-a3b7-c6accb15eba62025-01-08Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 087393
application number: ANDA087393

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
864761methadone HCl 5 MG in 5 mL Oral SolutionPSNeff99966-a35c-4952-a9aa-1344da90b9eb5
864761methadone hydrochloride 1 MG/ML Oral SolutionSCDeff99966-a35c-4952-a9aa-1344da90b9eb5
864761methadone HCl 5 MG per 5 ML Oral SolutionSYeff99966-a35c-4952-a9aa-1344da90b9eb5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
17856-3554-11785635540148 SYRINGE in 1 BOX, UNIT-DOSE (17856-3554-1) > 5 mL in 1 SYRINGE48 syringe2021-01-260000-00-00NoNoCurrent
17856-3554-21785635540248 SYRINGE in 1 BOX, UNIT-DOSE (17856-3554-2) > 5 mL in 1 SYRINGE48 syringe2021-01-260000-00-00NoNoCurrent
17856-3554-31785635540372 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE (17856-3554-3) > 10 mL in 1 CUP, UNIT-DOSE2021-04-290000-00-00NoNoCurrent