Home NDC 66689-712 Methadone Hydrochloride
Product NDC 66689-712
11-digit product format 666890712
Labeler code 66689
Product ID 66689-712_ea0de6af-8e1d-4d04-acc4-10177280badf
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Methadone Hydrochloride
Dosage form SOLUTION
Route ORAL
Labeler VistaPharm, Inc.
Application ANDA090707
Marketing category ANDA
Marketing start 2010-08-01
Marketing end 0000-00-00
Substance METHADONE HYDROCHLORIDE
Active strength 10 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 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 · 2 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product 66689-712 D Discontinued by firm excluded / ndc_excluded.zip d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 66689-712 66689-712-16 D Discontinued by firm excluded / ndc_excluded.zip d630ba8d3edf…732f749b63fb…
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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A090707-001 METHADONE HYDROCHLORIDE METHADONE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA 2010-06-30 A090707-002 METHADONE HYDROCHLORIDE METHADONE HYDROCHLORIDE 10MG/5ML SOLUTION / ORAL 2010-06-30
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A090707-001 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.
Product history page 1 of 3 · 82 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 2026-02-19 14:30 UTC 2026-02 A090707-001 METHADONE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL 2010-06-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A090707-002 METHADONE HYDROCHLORIDE 10MG/5ML SOLUTION / ORAL 2010-06-30 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090707-001 METHADONE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL 2010-06-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090707-002 METHADONE HYDROCHLORIDE 10MG/5ML SOLUTION / ORAL 2010-06-30 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A090707-001 METHADONE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL 2010-06-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A090707-002 METHADONE HYDROCHLORIDE 10MG/5ML SOLUTION / ORAL 2010-06-30 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090707-001 METHADONE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL 2010-06-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090707-002 METHADONE HYDROCHLORIDE 10MG/5ML SOLUTION / ORAL 2010-06-30 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090707-001 METHADONE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL 2010-06-30 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090707-002 METHADONE HYDROCHLORIDE 10MG/5ML SOLUTION / ORAL 2010-06-30 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090707-001 METHADONE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL 2010-06-30 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090707-002 METHADONE HYDROCHLORIDE 10MG/5ML SOLUTION / ORAL 2010-06-30 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090707-001 METHADONE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL 2010-06-30 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090707-002 METHADONE HYDROCHLORIDE 10MG/5ML SOLUTION / ORAL 2010-06-30 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A090707-001 METHADONE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL 2010-06-30 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A090707-002 METHADONE HYDROCHLORIDE 10MG/5ML SOLUTION / ORAL 2010-06-30 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A090707-001 METHADONE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL 2010-06-30 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A090707-002 METHADONE HYDROCHLORIDE 10MG/5ML SOLUTION / ORAL 2010-06-30 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A090707-001 METHADONE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL 2010-06-30 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A090707-002 METHADONE HYDROCHLORIDE 10MG/5ML SOLUTION / ORAL 2010-06-30 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A090707-001 METHADONE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL 2010-06-30 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A090707-002 METHADONE HYDROCHLORIDE 10MG/5ML SOLUTION / ORAL 2010-06-30 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A090707-001 METHADONE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL 2010-06-30 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A090707-002 METHADONE HYDROCHLORIDE 10MG/5ML SOLUTION / ORAL 2010-06-30 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A090707-001 METHADONE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA 2010-06-30 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A090707-002 METHADONE HYDROCHLORIDE 10MG/5ML SOLUTION / ORAL AA 2010-06-30 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A090707-001 METHADONE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA 2010-06-30 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A090707-002 METHADONE HYDROCHLORIDE 10MG/5ML SOLUTION / ORAL AA 2010-06-30 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A090707-001 METHADONE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA 2010-06-30 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A090707-002 METHADONE HYDROCHLORIDE 10MG/5ML SOLUTION / ORAL AA 2010-06-30 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A090707-001 METHADONE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA 2010-06-30 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A090707-002 METHADONE HYDROCHLORIDE 10MG/5ML SOLUTION / ORAL AA 2010-06-30 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A090707-001 METHADONE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA 2010-06-30 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A090707-002 METHADONE HYDROCHLORIDE 10MG/5ML SOLUTION / ORAL AA 2010-06-30 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A090707-001 METHADONE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA 2010-06-30 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A090707-002 METHADONE HYDROCHLORIDE 10MG/5ML SOLUTION / ORAL AA 2010-06-30 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A090707-001 METHADONE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA 2010-06-30 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A090707-002 METHADONE HYDROCHLORIDE 10MG/5ML SOLUTION / ORAL AA 2010-06-30 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A090707-001 METHADONE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA 2010-06-30 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A090707-002 METHADONE HYDROCHLORIDE 10MG/5ML SOLUTION / ORAL AA 2010-06-30 782e0a99824c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 57 observed states.
FDA-Initiated Inactive NDC Indexing# DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 66689-712 METHADONE HYDROCHLORIDE SOLUTION [VISTAPHARM, LLC] 28 Legacy NDC 20240712_7ff89589-149c-4007-8144-5f60131b8c33.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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 66689-712-16 66689071216 500 mL in 1 BOTTLE (66689-712-16) 500 ml 2010-08-01 0000-00-00 No No Current