Home NDC 66689-694-30 Methadone Hydrochloride
Product NDC 66689-694
Requested package NDC 66689-694-30
11-digit product format 666890694
Labeler code 66689
Product ID 66689-694_a139d04a-25e0-499f-8bfb-43328f560410
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Methadone Hydrochloride
Dosage form CONCENTRATE
Route ORAL
Labeler VistaPharm, LLC
Application ANDA040088
Marketing category ANDA
Marketing start 2009-10-30
Substance METHADONE HYDROCHLORIDE
Active strength 10 mg/mL
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 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 package package 66689-694 66689-694-30 D Discontinued by firm excluded / ndc_excluded.zip d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 66689-694 66689-694-30 D Discontinued by firm excluded / ndc_excluded.zip f5e01cc5f278…a2eaf40c39c3…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
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 A040088-001 METHADONE HYDROCHLORIDE METHADONE HYDROCHLORIDE 10MG/ML CONCENTRATE / ORAL AA 1994-11-30
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A040088-001 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 2 · 42 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 A040088-001 METHADONE HYDROCHLORIDE 10MG/ML CONCENTRATE / ORAL AA 1994-11-30 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A040088-001 METHADONE HYDROCHLORIDE 10MG/ML CONCENTRATE / ORAL AA 1994-11-30 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A040088-001 METHADONE HYDROCHLORIDE 10MG/ML CONCENTRATE / ORAL AA 1994-11-30 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A040088-001 METHADONE HYDROCHLORIDE 10MG/ML CONCENTRATE / ORAL AA 1994-11-30 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A040088-001 METHADONE HYDROCHLORIDE 10MG/ML CONCENTRATE / ORAL AA 1994-11-30 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A040088-001 METHADONE HYDROCHLORIDE 10MG/ML CONCENTRATE / ORAL AA 1994-11-30 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A040088-001 METHADONE HYDROCHLORIDE 10MG/ML CONCENTRATE / ORAL AA 1994-11-30 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A040088-001 METHADONE HYDROCHLORIDE 10MG/ML CONCENTRATE / ORAL AA 1994-11-30 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A040088-001 METHADONE HYDROCHLORIDE 10MG/ML CONCENTRATE / ORAL AA 1994-11-30 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A040088-001 METHADONE HYDROCHLORIDE 10MG/ML CONCENTRATE / ORAL AA 1994-11-30 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A040088-001 METHADONE HYDROCHLORIDE 10MG/ML CONCENTRATE / ORAL AA 1994-11-30 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A040088-001 METHADONE HYDROCHLORIDE 10MG/ML CONCENTRATE / ORAL AA 1994-11-30 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A040088-001 METHADONE HYDROCHLORIDE 10MG/ML CONCENTRATE / ORAL AA 1994-11-30 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A040088-001 METHADONE HYDROCHLORIDE 10MG/ML CONCENTRATE / ORAL AA 1994-11-30 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A040088-001 METHADONE HYDROCHLORIDE 10MG/ML CONCENTRATE / ORAL AA 1994-11-30 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A040088-001 METHADONE HYDROCHLORIDE 10MG/ML CONCENTRATE / ORAL AA 1994-11-30 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A040088-001 METHADONE HYDROCHLORIDE 10MG/ML CONCENTRATE / ORAL AA 1994-11-30 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A040088-001 METHADONE HYDROCHLORIDE 10MG/ML CONCENTRATE / ORAL AA 1994-11-30 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A040088-001 METHADONE HYDROCHLORIDE 10MG/ML CONCENTRATE / ORAL AA 1994-11-30 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A040088-001 METHADONE HYDROCHLORIDE 10MG/ML CONCENTRATE / ORAL AA 1994-11-30 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A040088-001 METHADONE HYDROCHLORIDE 10MG/ML CONCENTRATE / ORAL AA 1994-11-30 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A040088-001 METHADONE HYDROCHLORIDE 10MG/ML CONCENTRATE / ORAL AA 1994-11-30 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A040088-001 METHADONE HYDROCHLORIDE 10MG/ML CONCENTRATE / ORAL AA 1994-11-30 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A040088-001 METHADONE HYDROCHLORIDE 10MG/ML CONCENTRATE / ORAL AA 1994-11-30 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A040088-001 METHADONE HYDROCHLORIDE 10MG/ML CONCENTRATE / ORAL AA 1994-11-30 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A040088-001 METHADONE HYDROCHLORIDE 10MG/ML CONCENTRATE / ORAL AA 1994-11-30 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A040088-001 METHADONE HYDROCHLORIDE 10MG/ML CONCENTRATE / ORAL AA 1994-11-30 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A040088-001 METHADONE HYDROCHLORIDE 10MG/ML CONCENTRATE / ORAL AA 1994-11-30 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A040088-001 METHADONE HYDROCHLORIDE 10MG/ML CONCENTRATE / ORAL AA 1994-11-30 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A040088-001 METHADONE HYDROCHLORIDE 10MG/ML CONCENTRATE / ORAL AA 1994-11-30 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A040088-001 METHADONE HYDROCHLORIDE 10MG/ML CONCENTRATE / ORAL AA 1994-11-30 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A040088-001 METHADONE HYDROCHLORIDE 10MG/ML CONCENTRATE / ORAL AA 1994-11-30 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A040088-001 METHADONE HYDROCHLORIDE 10MG/ML CONCENTRATE / ORAL AA 1994-11-30 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A040088-001 METHADONE HYDROCHLORIDE 10MG/ML CONCENTRATE / ORAL AA 1994-11-30 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A040088-001 METHADONE HYDROCHLORIDE 10MG/ML CONCENTRATE / ORAL AA 1994-11-30 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A040088-001 METHADONE HYDROCHLORIDE 10MG/ML CONCENTRATE / ORAL AA 1994-11-30 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A040088-001 METHADONE HYDROCHLORIDE 10MG/ML CONCENTRATE / ORAL AA 1994-11-30 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A040088-001 METHADONE HYDROCHLORIDE 10MG/ML CONCENTRATE / ORAL AA 1994-11-30 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A040088-001 METHADONE HYDROCHLORIDE 10MG/ML CONCENTRATE / ORAL AA 1994-11-30 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A040088-001 METHADONE HYDROCHLORIDE 10MG/ML CONCENTRATE / ORAL AA 1994-11-30 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
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/mL
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 991147 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 66689-694-30 Methadone Hydrochloride 30 mL in 1 BOTTLE, DROPPER CONCENTRATE 30 24 66689-694-79 Methadone Hydrochloride 1000 mL in 1 BOTTLE CONCENTRATE 1000 24 66689-694-88 Methadone Hydrochloride 4000 mL in 1 BOTTLE CONCENTRATE 4000 24
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 66689-694 METHADONE HYDROCHLORIDE CONCENTRATE [VISTAPHARM, LLC] 22 Current NDC, Legacy NDC, 3 package rows 20250126_d5bd3e97-b3f6-4bc2-9fb7-02921be35cdb.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 66689-694-30 66689069430 30 mL in 1 BOTTLE, DROPPER (66689-694-30) 30 ml 2009-10-30 0000-00-00 No No Current