Home NDC 0406-4123 Methadone Hydrochloride
Product NDC 0406-4123
11-digit product format 004064123
Labeler code 0406
Product ID 0406-4123_f3e27571-1978-4639-a625-a7ff53e446d6
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Methadone Hydrochloride
Dosage form CONCENTRATE
Route ORAL
Labeler SpecGx LLC
Application ANDA207368
Marketing category ANDA
Marketing start 2021-06-18
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 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 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A207368-001 METHADONE HYDROCHLORIDE METHADONE HYDROCHLORIDE 10MG/ML CONCENTRATE / ORAL AA 2019-08-22
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A207368-001 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 · 41 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 A207368-001 METHADONE HYDROCHLORIDE 10MG/ML CONCENTRATE / ORAL AA 2019-08-22 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A207368-001 METHADONE HYDROCHLORIDE 10MG/ML CONCENTRATE / ORAL AA 2019-08-22 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A207368-001 METHADONE HYDROCHLORIDE 10MG/ML CONCENTRATE / ORAL AA 2019-08-22 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A207368-001 METHADONE HYDROCHLORIDE 10MG/ML CONCENTRATE / ORAL AA 2019-08-22 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A207368-001 METHADONE HYDROCHLORIDE 10MG/ML CONCENTRATE / ORAL AA 2019-08-22 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A207368-001 METHADONE HYDROCHLORIDE 10MG/ML CONCENTRATE / ORAL AA 2019-08-22 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A207368-001 METHADONE HYDROCHLORIDE 10MG/ML CONCENTRATE / ORAL AA 2019-08-22 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A207368-001 METHADONE HYDROCHLORIDE 10MG/ML CONCENTRATE / ORAL AA 2019-08-22 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A207368-001 METHADONE HYDROCHLORIDE 10MG/ML CONCENTRATE / ORAL AA 2019-08-22 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A207368-001 METHADONE HYDROCHLORIDE 10MG/ML CONCENTRATE / ORAL AA 2019-08-22 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A207368-001 METHADONE HYDROCHLORIDE 10MG/ML CONCENTRATE / ORAL AA 2019-08-22 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A207368-001 METHADONE HYDROCHLORIDE 10MG/ML CONCENTRATE / ORAL AA 2019-08-22 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A207368-001 METHADONE HYDROCHLORIDE 10MG/ML CONCENTRATE / ORAL AA 2019-08-22 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A207368-001 METHADONE HYDROCHLORIDE 10MG/ML CONCENTRATE / ORAL AA 2019-08-22 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A207368-001 METHADONE HYDROCHLORIDE 10MG/ML CONCENTRATE / ORAL AA 2019-08-22 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A207368-001 METHADONE HYDROCHLORIDE 10MG/ML CONCENTRATE / ORAL AA 2019-08-22 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A207368-001 METHADONE HYDROCHLORIDE 10MG/ML CONCENTRATE / ORAL AA 2019-08-22 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A207368-001 METHADONE HYDROCHLORIDE 10MG/ML CONCENTRATE / ORAL AA 2019-08-22 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A207368-001 METHADONE HYDROCHLORIDE 10MG/ML CONCENTRATE / ORAL AA 2019-08-22 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A207368-001 METHADONE HYDROCHLORIDE 10MG/ML CONCENTRATE / ORAL AA 2019-08-22 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A207368-001 METHADONE HYDROCHLORIDE 10MG/ML CONCENTRATE / ORAL AA 2019-08-22 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A207368-001 METHADONE HYDROCHLORIDE 10MG/ML CONCENTRATE / ORAL AA 2019-08-22 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A207368-001 METHADONE HYDROCHLORIDE 10MG/ML CONCENTRATE / ORAL AA 2019-08-22 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A207368-001 METHADONE HYDROCHLORIDE 10MG/ML CONCENTRATE / ORAL AA 2019-08-22 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A207368-001 METHADONE HYDROCHLORIDE 10MG/ML CONCENTRATE / ORAL AA 2019-08-22 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A207368-001 METHADONE HYDROCHLORIDE 10MG/ML CONCENTRATE / ORAL AA 2019-08-22 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A207368-001 METHADONE HYDROCHLORIDE 10MG/ML CONCENTRATE / ORAL AA 2019-08-22 b00525d2431f…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A207368-001 METHADONE HYDROCHLORIDE 10MG/ML CONCENTRATE / ORAL AA 2019-08-22 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A207368-001 METHADONE HYDROCHLORIDE 10MG/ML CONCENTRATE / ORAL AA 2019-08-22 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A207368-001 METHADONE HYDROCHLORIDE 10MG/ML CONCENTRATE / ORAL AA 2019-08-22 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A207368-001 METHADONE HYDROCHLORIDE 10MG/ML CONCENTRATE / ORAL AA 2019-08-22 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A207368-001 METHADONE HYDROCHLORIDE 10MG/ML CONCENTRATE / ORAL AA 2019-08-22 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A207368-001 METHADONE HYDROCHLORIDE 10MG/ML CONCENTRATE / ORAL AA 2019-08-22 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A207368-001 METHADONE HYDROCHLORIDE 10MG/ML CONCENTRATE / ORAL AA 2019-08-22 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A207368-001 METHADONE HYDROCHLORIDE 10MG/ML CONCENTRATE / ORAL AA 2019-08-22 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A207368-001 METHADONE HYDROCHLORIDE 10MG/ML CONCENTRATE / ORAL AA 2019-08-22 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A207368-001 METHADONE HYDROCHLORIDE 10MG/ML CONCENTRATE / ORAL AA 2019-08-22 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A207368-001 METHADONE HYDROCHLORIDE 10MG/ML CONCENTRATE / ORAL AA 2019-08-22 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A207368-001 METHADONE HYDROCHLORIDE 10MG/ML CONCENTRATE / ORAL AA 2019-08-22 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A207368-001 METHADONE HYDROCHLORIDE 10MG/ML CONCENTRATE / ORAL AA 2019-08-22 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 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 0406-4123-03 Methadone Hydrochloride 30 mL in 1 BOTTLE, DROPPER CONCENTRATE 30 7 0406-4123-03 Methadone Hydrochloride 1 in 1 CARTON CONCENTRATE 1 7 0406-4123-10 Methadone Hydrochloride 1000 mL in 1 BOTTLE CONCENTRATE 1000 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0406-4123 METHADONE HYDROCHLORIDE CONCENTRATE [SPECGX LLC] 4 Current NDC, Legacy NDC, 3 package rows 20241116_14f7b1d8-344a-4eaa-a1bf-bc1a00c3ab58.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 0406-4123-03 00406412303 1 BOTTLE, DROPPER in 1 CARTON (0406-4123-03) / 30 mL in 1 BOTTLE, DROPPER 2021-06-18 0000-00-00 No No Current 0406-4123-10 00406412310 1000 mL in 1 BOTTLE (0406-4123-10) 1000 ml 2021-06-18 0000-00-00 No No Current