Home NDC 66689-836 Methadone Hydrochloride
Product NDC 66689-836
11-digit product format 666890836
Labeler code 66689
Product ID 66689-836_b76dbddc-b042-47d7-a7a7-f64c7c5c5035
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Methadone
Dosage form TABLET
Route ORAL
Labeler VistaPharm, LLC
Application ANDA204166
Marketing category ANDA
Marketing start 2020-09-11
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 2027-12-31
Current FDA listing Yes 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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A204166-001 METHADONE HYDROCHLORIDE METHADONE HYDROCHLORIDE 10MG TABLET / ORAL AA 2020-03-16
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A204166-001 AA
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.
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 2026-02-19 14:30 UTC 2026-02 A204166-001 METHADONE HYDROCHLORIDE 10MG TABLET / ORAL AA 2020-03-16 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A204166-001 METHADONE HYDROCHLORIDE 10MG TABLET / ORAL AA 2020-03-16 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A204166-001 METHADONE HYDROCHLORIDE 10MG TABLET / ORAL AA 2020-03-16 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A204166-001 METHADONE HYDROCHLORIDE 10MG TABLET / ORAL AA 2020-03-16 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A204166-001 METHADONE HYDROCHLORIDE 10MG TABLET / ORAL AA 2020-03-16 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A204166-001 METHADONE HYDROCHLORIDE 10MG TABLET / ORAL AA 2020-03-16 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A204166-001 METHADONE HYDROCHLORIDE 10MG TABLET / ORAL AA 2020-03-16 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A204166-001 METHADONE HYDROCHLORIDE 10MG TABLET / ORAL AA 2020-03-16 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A204166-001 METHADONE HYDROCHLORIDE 10MG TABLET / ORAL AA 2020-03-16 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A204166-001 METHADONE HYDROCHLORIDE 10MG TABLET / ORAL AA 2020-03-16 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A204166-001 METHADONE HYDROCHLORIDE 10MG TABLET / ORAL AA 2020-03-16 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A204166-001 METHADONE HYDROCHLORIDE 10MG TABLET / ORAL AA 2020-03-16 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A204166-001 METHADONE HYDROCHLORIDE 10MG TABLET / ORAL AA 2020-03-16 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A204166-001 METHADONE HYDROCHLORIDE 10MG TABLET / ORAL AA 2020-03-16 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A204166-001 METHADONE HYDROCHLORIDE 10MG TABLET / ORAL AA 2020-03-16 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A204166-001 METHADONE HYDROCHLORIDE 10MG TABLET / ORAL AA 2020-03-16 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A204166-001 METHADONE HYDROCHLORIDE 10MG TABLET / ORAL AA 2020-03-16 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A204166-001 METHADONE HYDROCHLORIDE 10MG TABLET / ORAL AA 2020-03-16 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A204166-001 METHADONE HYDROCHLORIDE 10MG TABLET / ORAL AA 2020-03-16 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A204166-001 METHADONE HYDROCHLORIDE 10MG TABLET / ORAL AA 2020-03-16 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A204166-001 METHADONE HYDROCHLORIDE 10MG TABLET / ORAL AA 2020-03-16 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A204166-001 METHADONE HYDROCHLORIDE 10MG TABLET / ORAL AA 2020-03-16 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A204166-001 METHADONE HYDROCHLORIDE 10MG TABLET / ORAL AA 2020-03-16 c0c555d07b60…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A204166-001 METHADONE HYDROCHLORIDE 10MG TABLET / ORAL AA 2020-03-16 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A204166-001 METHADONE HYDROCHLORIDE 10MG TABLET / ORAL AA 2020-03-16 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A204166-001 METHADONE HYDROCHLORIDE 10MG TABLET / ORAL AA 2020-03-16 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A204166-001 METHADONE HYDROCHLORIDE 10MG TABLET / ORAL AA 2020-03-16 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A204166-001 METHADONE HYDROCHLORIDE 10MG TABLET / ORAL AA 2020-03-16 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A204166-001 METHADONE HYDROCHLORIDE 10MG TABLET / ORAL AA 2020-03-16 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A204166-001 METHADONE HYDROCHLORIDE 10MG TABLET / ORAL AA 2020-03-16 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A204166-001 METHADONE HYDROCHLORIDE 10MG TABLET / ORAL AA 2020-03-16 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A204166-001 METHADONE HYDROCHLORIDE 10MG TABLET / ORAL AA 2020-03-16 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A204166-001 METHADONE HYDROCHLORIDE 10MG TABLET / ORAL AA 2020-03-16 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A204166-001 METHADONE HYDROCHLORIDE 10MG TABLET / ORAL AA 2020-03-16 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A204166-001 METHADONE HYDROCHLORIDE 10MG TABLET / ORAL AA 2020-03-16 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A204166-001 METHADONE HYDROCHLORIDE 10MG TABLET / ORAL AA 2020-03-16 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A204166-001 METHADONE HYDROCHLORIDE 10MG TABLET / ORAL AA 2020-03-16 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Methadone Hydrochloride
Listing expiration 2027-12-31 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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 864706 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 66689-836-99 Methadone Hydrochloride 100 in 1 BOTTLE, PLASTIC TABLET 100 17
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 66689-836 METHADONE HYDROCHLORIDE (METHADONE) TABLET [VISTAPHARM, LLC] 15 Current NDC, Legacy NDC, 1 package rows 20250316_4a44bde6-c348-4316-b0e0-c24b407cb823.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 · 1 matching rows.
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 66689-836-99 66689083699 100 TABLET in 1 BOTTLE, PLASTIC (66689-836-99) 100 tablet 2020-09-11 0000-00-00 No No Current