Home NDC 0406-5755 METHADONE HYDROCHLORIDE
Product NDC 0406-5755
11-digit product format 004065755
Labeler code 0406
Product ID 0406-5755_5084c093-f783-4043-8e6f-eb747a2c1d81
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name METHADONE HYDROCHLORIDE
Dosage form TABLET
Route ORAL
Labeler SpecGx LLC
Application ANDA040517
Marketing category ANDA
Marketing start 2004-04-27
Substance METHADONE HYDROCHLORIDE
Active strength 5 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 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 A040517-001 METHADONE HYDROCHLORIDE METHADONE HYDROCHLORIDE 5MG TABLET / ORAL AA RS 2004-04-27 A040517-002 METHADONE HYDROCHLORIDE METHADONE HYDROCHLORIDE 10MG TABLET / ORAL AA RS 2004-04-27
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 3 · 84 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 A040517-001 METHADONE HYDROCHLORIDE 5MG TABLET / ORAL AA RS 2004-04-27 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A040517-002 METHADONE HYDROCHLORIDE 10MG TABLET / ORAL AA RS 2004-04-27 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A040517-001 METHADONE HYDROCHLORIDE 5MG TABLET / ORAL AA RS 2004-04-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A040517-002 METHADONE HYDROCHLORIDE 10MG TABLET / ORAL AA RS 2004-04-27 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A040517-001 METHADONE HYDROCHLORIDE 5MG TABLET / ORAL AA RS 2004-04-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A040517-002 METHADONE HYDROCHLORIDE 10MG TABLET / ORAL AA RS 2004-04-27 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A040517-001 METHADONE HYDROCHLORIDE 5MG TABLET / ORAL AA RS 2004-04-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A040517-002 METHADONE HYDROCHLORIDE 10MG TABLET / ORAL AA RS 2004-04-27 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A040517-001 METHADONE HYDROCHLORIDE 5MG TABLET / ORAL AA RS 2004-04-27 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A040517-002 METHADONE HYDROCHLORIDE 10MG TABLET / ORAL AA RS 2004-04-27 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A040517-001 METHADONE HYDROCHLORIDE 5MG TABLET / ORAL AA RS 2004-04-27 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A040517-002 METHADONE HYDROCHLORIDE 10MG TABLET / ORAL AA RS 2004-04-27 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A040517-001 METHADONE HYDROCHLORIDE 5MG TABLET / ORAL AA RS 2004-04-27 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A040517-002 METHADONE HYDROCHLORIDE 10MG TABLET / ORAL AA RS 2004-04-27 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A040517-001 METHADONE HYDROCHLORIDE 5MG TABLET / ORAL AA RS 2004-04-27 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A040517-002 METHADONE HYDROCHLORIDE 10MG TABLET / ORAL AA RS 2004-04-27 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A040517-001 METHADONE HYDROCHLORIDE 5MG TABLET / ORAL AA RS 2004-04-27 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A040517-002 METHADONE HYDROCHLORIDE 10MG TABLET / ORAL AA RS 2004-04-27 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A040517-001 METHADONE HYDROCHLORIDE 5MG TABLET / ORAL AA RS 2004-04-27 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A040517-002 METHADONE HYDROCHLORIDE 10MG TABLET / ORAL AA RS 2004-04-27 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A040517-001 METHADONE HYDROCHLORIDE 5MG TABLET / ORAL AA RS 2004-04-27 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A040517-002 METHADONE HYDROCHLORIDE 10MG TABLET / ORAL AA RS 2004-04-27 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A040517-001 METHADONE HYDROCHLORIDE 5MG TABLET / ORAL AA RS 2004-04-27 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A040517-002 METHADONE HYDROCHLORIDE 10MG TABLET / ORAL AA RS 2004-04-27 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A040517-001 METHADONE HYDROCHLORIDE 5MG TABLET / ORAL AA RS 2004-04-27 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A040517-002 METHADONE HYDROCHLORIDE 10MG TABLET / ORAL AA RS 2004-04-27 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A040517-001 METHADONE HYDROCHLORIDE 5MG TABLET / ORAL AA RS 2004-04-27 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A040517-002 METHADONE HYDROCHLORIDE 10MG TABLET / ORAL AA RS 2004-04-27 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A040517-001 METHADONE HYDROCHLORIDE 5MG TABLET / ORAL AA RS 2004-04-27 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A040517-002 METHADONE HYDROCHLORIDE 10MG TABLET / ORAL AA RS 2004-04-27 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A040517-001 METHADONE HYDROCHLORIDE 5MG TABLET / ORAL AA RS 2004-04-27 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A040517-002 METHADONE HYDROCHLORIDE 10MG TABLET / ORAL AA RS 2004-04-27 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A040517-001 METHADONE HYDROCHLORIDE 5MG TABLET / ORAL AA RS 2004-04-27 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A040517-002 METHADONE HYDROCHLORIDE 10MG TABLET / ORAL AA RS 2004-04-27 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A040517-001 METHADONE HYDROCHLORIDE 5MG TABLET / ORAL AA RS 2004-04-27 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A040517-002 METHADONE HYDROCHLORIDE 10MG TABLET / ORAL AA RS 2004-04-27 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A040517-001 METHADONE HYDROCHLORIDE 5MG TABLET / ORAL AA 2004-04-27 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A040517-002 METHADONE HYDROCHLORIDE 10MG TABLET / ORAL AA 2004-04-27 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A040517-001 METHADONE HYDROCHLORIDE 5MG TABLET / ORAL AA RS 2004-04-27 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A040517-002 METHADONE HYDROCHLORIDE 10MG TABLET / ORAL AA RS 2004-04-27 bb7c543d1eb4…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 84 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/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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 864706 Internal RxNorm lookup 864718 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 0406-5755-01 METHADONE HYDROCHLORIDE 100 in 1 BOTTLE TABLET 100 47 0406-5755-23 METHADONE HYDROCHLORIDE 1 in 1 BLISTER PACK TABLET 1 47 0406-5755-62 METHADONE HYDROCHLORIDE 100 in 1 BLISTER PACK TABLET 100 47
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded METHADONE HYDROCHLORIDE ACTIVE INGREDIENT 229809935B METHADONE HYDROCHLORIDE TABLET [MALLINCKRODT, INC.] 20 METHADONE ACTIVE MOIETY UC6VBE7V1Z METHADONE HYDROCHLORIDE TABLET [MALLINCKRODT, INC.] 20 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U METHADONE HYDROCHLORIDE TABLET [MALLINCKRODT, INC.] 20 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X METHADONE HYDROCHLORIDE TABLET [MALLINCKRODT, INC.] 20 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 METHADONE HYDROCHLORIDE TABLET [MALLINCKRODT, INC.] 20 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 METHADONE HYDROCHLORIDE TABLET [MALLINCKRODT, INC.] 20 METHADONE HYDROCHLORIDE ACTIVE INGREDIENT 229809935B METHADONE HYDROCHLORIDE TABLET [H.J. HARKINS COMPANY INC.] 3 METHADONE ACTIVE MOIETY UC6VBE7V1Z METHADONE HYDROCHLORIDE TABLET [H.J. HARKINS COMPANY INC.] 3 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U METHADONE HYDROCHLORIDE TABLET [H.J. HARKINS COMPANY INC.] 3 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X METHADONE HYDROCHLORIDE TABLET [H.J. HARKINS COMPANY INC.] 3 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 METHADONE HYDROCHLORIDE TABLET [H.J. HARKINS COMPANY INC.] 3 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 METHADONE HYDROCHLORIDE TABLET [H.J. HARKINS COMPANY INC.] 3 METHADONE HYDROCHLORIDE ACTIVE INGREDIENT 229809935B METHADONE HYDROCHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.] 1 METHADONE HYDROCHLORIDE ACTIVE INGREDIENT 229809935B METHADONE HYDROCHLORIDE TABLET [STAT RX USA LLC] 1 METHADONE ACTIVE MOIETY UC6VBE7V1Z METHADONE HYDROCHLORIDE TABLET [STAT RX USA LLC] 1 METHADONE ACTIVE MOIETY UC6VBE7V1Z METHADONE HYDROCHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U METHADONE HYDROCHLORIDE TABLET [STAT RX USA LLC] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U METHADONE HYDROCHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.] 1 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X METHADONE HYDROCHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.] 1 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X METHADONE HYDROCHLORIDE TABLET [STAT RX USA LLC] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 METHADONE HYDROCHLORIDE TABLET [STAT RX USA LLC] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 METHADONE HYDROCHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.] 1 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 METHADONE HYDROCHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.] 1 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 METHADONE HYDROCHLORIDE TABLET [STAT RX USA LLC] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0406-5755 METHADONE HYDROCHLORIDE TABLET [SPECGX LLC] 45 Current NDC, Legacy NDC, 3 package rows 20240725_eddf7077-02fb-4771-9823-31984f4ff2bb.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 0406-5755-01 00406575501 100 TABLET in 1 BOTTLE (0406-5755-01) 100 tablet 2004-04-27 0000-00-00 No No Current 0406-5755-23 00406575523 1 TABLET in 1 BLISTER PACK (0406-5755-23) 1 tablet 2004-04-27 0000-00-00 No No Current 0406-5755-62 00406575562 100 TABLET in 1 BLISTER PACK (0406-5755-62) 100 tablet 2004-04-27 0000-00-00 No No Current