Home NDC 72865-121 Methadone Hydrochloride
Product NDC 72865-121
11-digit product format 728650121
Labeler code 72865
Product ID 72865-121_639b24e8-927d-46ef-82f8-914a10528f21
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Methadone Hydrochloride
Dosage form TABLET
Route ORAL
Labeler XLCare Pharmaceuticals, Inc
Application ANDA211228
Marketing category ANDA
Marketing start 2019-01-03
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 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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A211228-001 METHADONE HYDROCHLORIDE METHADONE HYDROCHLORIDE 5MG TABLET / ORAL AA 2019-01-03 A211228-002 METHADONE HYDROCHLORIDE METHADONE HYDROCHLORIDE 10MG TABLET / ORAL AA 2019-01-03
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
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 3 · 84 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-18 06:07:40 2026-07 A211228-001 METHADONE HYDROCHLORIDE 5MG TABLET / ORAL AA 2019-01-03 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A211228-002 METHADONE HYDROCHLORIDE 10MG TABLET / ORAL AA 2019-01-03 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A211228-001 METHADONE HYDROCHLORIDE 5MG TABLET / ORAL AA 2019-01-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A211228-002 METHADONE HYDROCHLORIDE 10MG TABLET / ORAL AA 2019-01-03 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A211228-001 METHADONE HYDROCHLORIDE 5MG TABLET / ORAL AA 2019-01-03 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A211228-002 METHADONE HYDROCHLORIDE 10MG TABLET / ORAL AA 2019-01-03 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A211228-001 METHADONE HYDROCHLORIDE 5MG TABLET / ORAL AA 2019-01-03 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A211228-002 METHADONE HYDROCHLORIDE 10MG TABLET / ORAL AA 2019-01-03 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A211228-001 METHADONE HYDROCHLORIDE 5MG TABLET / ORAL AA 2019-01-03 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A211228-002 METHADONE HYDROCHLORIDE 10MG TABLET / ORAL AA 2019-01-03 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A211228-001 METHADONE HYDROCHLORIDE 5MG TABLET / ORAL AA 2019-01-03 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A211228-002 METHADONE HYDROCHLORIDE 10MG TABLET / ORAL AA 2019-01-03 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A211228-001 METHADONE HYDROCHLORIDE 5MG TABLET / ORAL AA 2019-01-03 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A211228-002 METHADONE HYDROCHLORIDE 10MG TABLET / ORAL AA 2019-01-03 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A211228-001 METHADONE HYDROCHLORIDE 5MG TABLET / ORAL AA 2019-01-03 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A211228-002 METHADONE HYDROCHLORIDE 10MG TABLET / ORAL AA 2019-01-03 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A211228-001 METHADONE HYDROCHLORIDE 5MG TABLET / ORAL AA 2019-01-03 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A211228-002 METHADONE HYDROCHLORIDE 10MG TABLET / ORAL AA 2019-01-03 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A211228-001 METHADONE HYDROCHLORIDE 5MG TABLET / ORAL AA 2019-01-03 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A211228-002 METHADONE HYDROCHLORIDE 10MG TABLET / ORAL AA 2019-01-03 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A211228-001 METHADONE HYDROCHLORIDE 5MG TABLET / ORAL AA 2019-01-03 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A211228-002 METHADONE HYDROCHLORIDE 10MG TABLET / ORAL AA 2019-01-03 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A211228-001 METHADONE HYDROCHLORIDE 5MG TABLET / ORAL AA 2019-01-03 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A211228-002 METHADONE HYDROCHLORIDE 10MG TABLET / ORAL AA 2019-01-03 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A211228-001 METHADONE HYDROCHLORIDE 5MG TABLET / ORAL AA 2019-01-03 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A211228-002 METHADONE HYDROCHLORIDE 10MG TABLET / ORAL AA 2019-01-03 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A211228-001 METHADONE HYDROCHLORIDE 5MG TABLET / ORAL AA 2019-01-03 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A211228-002 METHADONE HYDROCHLORIDE 10MG TABLET / ORAL AA 2019-01-03 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A211228-001 METHADONE HYDROCHLORIDE 5MG TABLET / ORAL AA 2019-01-03 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A211228-002 METHADONE HYDROCHLORIDE 10MG TABLET / ORAL AA 2019-01-03 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A211228-001 METHADONE HYDROCHLORIDE 5MG TABLET / ORAL AA 2019-01-03 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A211228-002 METHADONE HYDROCHLORIDE 10MG TABLET / ORAL AA 2019-01-03 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A211228-001 METHADONE HYDROCHLORIDE 5MG TABLET / ORAL AA 2019-01-03 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A211228-002 METHADONE HYDROCHLORIDE 10MG TABLET / ORAL AA 2019-01-03 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A211228-001 METHADONE HYDROCHLORIDE 5MG TABLET / ORAL AA 2019-01-03 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A211228-002 METHADONE HYDROCHLORIDE 10MG TABLET / ORAL AA 2019-01-03 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A211228-001 METHADONE HYDROCHLORIDE 5MG TABLET / ORAL AA 2019-01-03 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A211228-002 METHADONE HYDROCHLORIDE 10MG TABLET / ORAL AA 2019-01-03 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A211228-001 METHADONE HYDROCHLORIDE 5MG TABLET / ORAL AA 2019-01-03 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A211228-002 METHADONE HYDROCHLORIDE 10MG TABLET / ORAL AA 2019-01-03 bb7c543d1eb4…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 84 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Methadone Hydrochloride
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength METHADONE HYDROCHLORIDE 10 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 229809935B Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 864706 Internal RxNorm lookup 864718 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 72865-121-01 Methadone Hydrochloride 100 in 1 BOTTLE TABLET 100 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 72865-121 METHADONE HYDROCHLORIDE TABLET [XLCARE PHARMACEUTICALS, INC] 3 Current NDC, Legacy NDC, 1 package rows 20240418_1a536622-dda3-41af-ab08-28e7c1bc9300.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 · 3 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Methadone Hydrochloride METHADONE HYDROCHLORIDE American Health Packaging 540edd43-165d-4257-b989-3bccc8f54afb 2026-08-03 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 211228 application number: ANDA211228 Methadone Hydrochloride METHADONE HYDROCHLORIDE Camber Pharmaceuticals, Inc 8f4cf84e-165c-489d-a668-0f715053f196 2025-08-28 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 211228 application number: ANDA211228 Methadone Hydrochloride METHADONE HYDROCHLORIDE XLCare Pharmaceuticals, Inc 1a536622-dda3-41af-ab08-28e7c1bc9300 2024-01-11 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 211228 application number: ANDA211228 ndc (product): 72865-121
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 72865-121-01 72865012101 100 TABLET in 1 BOTTLE (72865-121-01) 100 tablet 2019-01-03 0000-00-00 No No Current