Home NDC 0406-6225 METHADONE HYDROCHLORIDE
Product NDC 0406-6225
11-digit product format 004066225
Labeler code 0406
Product ID 0406-6225_4e01f70c-6006-4f0d-9fc9-a50788fe3fd1
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name METHADONE HYDROCHLORIDE
Dosage form SOLUTION
Route ORAL
Labeler SpecGx LLC
Application ANDA207537
Marketing category ANDA
Marketing start 2021-06-18
Substance METHADONE HYDROCHLORIDE
Active strength 5 mg/5mL
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 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 A207537-001 METHADONE HYDROCHLORIDE METHADONE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA 2019-10-02 A207537-002 METHADONE HYDROCHLORIDE METHADONE HYDROCHLORIDE 10MG/5ML SOLUTION / ORAL AA 2019-10-01
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 2 · 80 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 A207537-001 METHADONE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA 2019-10-02 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A207537-002 METHADONE HYDROCHLORIDE 10MG/5ML SOLUTION / ORAL AA 2019-10-01 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A207537-001 METHADONE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA 2019-10-02 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A207537-002 METHADONE HYDROCHLORIDE 10MG/5ML SOLUTION / ORAL AA 2019-10-01 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A207537-001 METHADONE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA 2019-10-02 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A207537-002 METHADONE HYDROCHLORIDE 10MG/5ML SOLUTION / ORAL AA 2019-10-01 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A207537-001 METHADONE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA 2019-10-02 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A207537-002 METHADONE HYDROCHLORIDE 10MG/5ML SOLUTION / ORAL AA 2019-10-01 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A207537-001 METHADONE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA 2019-10-02 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A207537-002 METHADONE HYDROCHLORIDE 10MG/5ML SOLUTION / ORAL AA 2019-10-01 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A207537-001 METHADONE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA 2019-10-02 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A207537-002 METHADONE HYDROCHLORIDE 10MG/5ML SOLUTION / ORAL AA 2019-10-01 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A207537-001 METHADONE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA 2019-10-02 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A207537-002 METHADONE HYDROCHLORIDE 10MG/5ML SOLUTION / ORAL AA 2019-10-01 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A207537-001 METHADONE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA 2019-10-02 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A207537-002 METHADONE HYDROCHLORIDE 10MG/5ML SOLUTION / ORAL AA 2019-10-01 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A207537-001 METHADONE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA 2019-10-02 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A207537-002 METHADONE HYDROCHLORIDE 10MG/5ML SOLUTION / ORAL AA 2019-10-01 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A207537-001 METHADONE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA 2019-10-02 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A207537-002 METHADONE HYDROCHLORIDE 10MG/5ML SOLUTION / ORAL AA 2019-10-01 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A207537-001 METHADONE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA 2019-10-02 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A207537-002 METHADONE HYDROCHLORIDE 10MG/5ML SOLUTION / ORAL AA 2019-10-01 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A207537-001 METHADONE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA 2019-10-02 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A207537-002 METHADONE HYDROCHLORIDE 10MG/5ML SOLUTION / ORAL AA 2019-10-01 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A207537-001 METHADONE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA 2019-10-02 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A207537-002 METHADONE HYDROCHLORIDE 10MG/5ML SOLUTION / ORAL AA 2019-10-01 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A207537-001 METHADONE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA 2019-10-02 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A207537-002 METHADONE HYDROCHLORIDE 10MG/5ML SOLUTION / ORAL AA 2019-10-01 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A207537-001 METHADONE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA 2019-10-02 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A207537-002 METHADONE HYDROCHLORIDE 10MG/5ML SOLUTION / ORAL AA 2019-10-01 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A207537-001 METHADONE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA 2019-10-02 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A207537-002 METHADONE HYDROCHLORIDE 10MG/5ML SOLUTION / ORAL AA 2019-10-01 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A207537-001 METHADONE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA 2019-10-02 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A207537-002 METHADONE HYDROCHLORIDE 10MG/5ML SOLUTION / ORAL AA 2019-10-01 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A207537-001 METHADONE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA 2019-10-02 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A207537-002 METHADONE HYDROCHLORIDE 10MG/5ML SOLUTION / ORAL AA 2019-10-01 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A207537-001 METHADONE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA 2019-10-02 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A207537-002 METHADONE HYDROCHLORIDE 10MG/5ML SOLUTION / ORAL AA 2019-10-01 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A207537-001 METHADONE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA 2019-10-02 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A207537-002 METHADONE HYDROCHLORIDE 10MG/5ML SOLUTION / ORAL AA 2019-10-01 bb7c543d1eb4…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 80 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 5 mg/5mL
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 864761 Internal RxNorm lookup 864769 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 0406-6225-05 METHADONE HYDROCHLORIDE 500 mL in 1 BOTTLE SOLUTION 500 10
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0406-6225 METHADONE HYDROCHLORIDE SOLUTION [SPECGX LLC] 7 Current NDC, Legacy NDC, 1 package rows 20240725_5baef1bf-8bf0-429c-a4ce-1c93171f3f15.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 0406-6225-05 00406622505 500 mL in 1 BOTTLE (0406-6225-05) 500 ml 2021-06-18 0000-00-00 No No Current