METHADONE HYDROCHLORIDE

Product NDC
63629-1027
Requested package NDC
63629-1027-1
11-digit product format
636291027
Labeler code
63629
Product ID
63629-1027_c513c20b-ef58-4df1-8cce-ab397ef8e67c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
METHADONE HYDROCHLORIDE
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA090635
Marketing category
ANDA
Marketing start
2012-01-16
Substance
METHADONE HYDROCHLORIDE
Active strength
10 mg/1
Pharmacologic classes
Full Opioid Agonists [MoA], Opioid Agonist [EPC]
DEA schedule
CII
NDC exclude flag
No
Listing certified through
2026-12-31
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 packagepackage63629-102763629-1027-1DDiscontinued by firm2026-08-03

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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 · 78 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A090635-001METHADONE 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…
2021-12-28 21:50 UTC2021-12A090635-002METHADONE HYDROCHLORIDE5MGTABLET / ORALAA2020-09-22782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A090635-001METHADONE HYDROCHLORIDE10MGTABLET / ORALAA2009-11-2587673890dc5c…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 78 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
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…
2021-12-28 21:50 UTC2021-12A090635-002AA1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A090635-001AA187673890dc5c…

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
63629-1027-1METHADONE HYDROCHLORIDE100 in 1 BOTTLETABLET10010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-1027-1EA - Each63629-10276f28868c-f31a-41a9-b06e-6c18e951bb4712019-08-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-1027METHADONE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]10Current NDC, Legacy NDC, 1 package rows20230127_3ce98ab4-346b-4680-b3e1-a8c29b3933af.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
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 TabletPSN3ce98ab4-346b-4680-b3e1-a8c29b3933af10
864706methadone hydrochloride 10 MG Oral TabletSCD3ce98ab4-346b-4680-b3e1-a8c29b3933af10

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-1027-163629102701100 TABLET in 1 BOTTLE (63629-1027-1) 100 tablet2020-01-160000-00-00NoNoCurrent