Home NDC 13107-088 Methadone Hydrochloride
Product NDC 13107-088
11-digit product format 131070088
Labeler code 13107
Product ID 13107-088_73006026-6ba2-49da-824e-a4d05b99a2e7
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Methadone Hydrochloride
Dosage form TABLET
Route ORAL
Labeler Aurolife Pharma, LLC
Application ANDA203502
Marketing category ANDA
Marketing start 2015-09-15
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 2026-12-31
Current FDA listing Yes 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 A203502-001 METHADONE HYDROCHLORIDE METHADONE HYDROCHLORIDE 5MG TABLET / ORAL AA 2015-08-31 A203502-002 METHADONE HYDROCHLORIDE METHADONE HYDROCHLORIDE 10MG TABLET / ORAL AA 2015-08-31
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 · 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 A203502-001 METHADONE HYDROCHLORIDE 5MG TABLET / ORAL AA 2015-08-31 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A203502-002 METHADONE HYDROCHLORIDE 10MG TABLET / ORAL AA 2015-08-31 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203502-001 METHADONE HYDROCHLORIDE 5MG TABLET / ORAL AA 2015-08-31 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203502-002 METHADONE HYDROCHLORIDE 10MG TABLET / ORAL AA 2015-08-31 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A203502-001 METHADONE HYDROCHLORIDE 5MG TABLET / ORAL AA 2015-08-31 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A203502-002 METHADONE HYDROCHLORIDE 10MG TABLET / ORAL AA 2015-08-31 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203502-001 METHADONE HYDROCHLORIDE 5MG TABLET / ORAL AA 2015-08-31 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203502-002 METHADONE HYDROCHLORIDE 10MG TABLET / ORAL AA 2015-08-31 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203502-001 METHADONE HYDROCHLORIDE 5MG TABLET / ORAL AA 2015-08-31 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203502-002 METHADONE HYDROCHLORIDE 10MG TABLET / ORAL AA 2015-08-31 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A203502-001 METHADONE HYDROCHLORIDE 5MG TABLET / ORAL AA 2015-08-31 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A203502-002 METHADONE HYDROCHLORIDE 10MG TABLET / ORAL AA 2015-08-31 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A203502-001 METHADONE HYDROCHLORIDE 5MG TABLET / ORAL AA 2015-08-31 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A203502-002 METHADONE HYDROCHLORIDE 10MG TABLET / ORAL AA 2015-08-31 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A203502-001 METHADONE HYDROCHLORIDE 5MG TABLET / ORAL AA 2015-08-31 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A203502-002 METHADONE HYDROCHLORIDE 10MG TABLET / ORAL AA 2015-08-31 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A203502-001 METHADONE HYDROCHLORIDE 5MG TABLET / ORAL AA 2015-08-31 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A203502-002 METHADONE HYDROCHLORIDE 10MG TABLET / ORAL AA 2015-08-31 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A203502-001 METHADONE HYDROCHLORIDE 5MG TABLET / ORAL AA 2015-08-31 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A203502-002 METHADONE HYDROCHLORIDE 10MG TABLET / ORAL AA 2015-08-31 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A203502-001 METHADONE HYDROCHLORIDE 5MG TABLET / ORAL AA 2015-08-31 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A203502-002 METHADONE HYDROCHLORIDE 10MG TABLET / ORAL AA 2015-08-31 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A203502-001 METHADONE HYDROCHLORIDE 5MG TABLET / ORAL AA 2015-08-31 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A203502-002 METHADONE HYDROCHLORIDE 10MG TABLET / ORAL AA 2015-08-31 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A203502-001 METHADONE HYDROCHLORIDE 5MG TABLET / ORAL AA 2015-08-31 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A203502-002 METHADONE HYDROCHLORIDE 10MG TABLET / ORAL AA 2015-08-31 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A203502-001 METHADONE HYDROCHLORIDE 5MG TABLET / ORAL AA 2015-08-31 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A203502-002 METHADONE HYDROCHLORIDE 10MG TABLET / ORAL AA 2015-08-31 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A203502-001 METHADONE HYDROCHLORIDE 5MG TABLET / ORAL AA 2015-08-31 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A203502-002 METHADONE HYDROCHLORIDE 10MG TABLET / ORAL AA 2015-08-31 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A203502-001 METHADONE HYDROCHLORIDE 5MG TABLET / ORAL AA 2015-08-31 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A203502-002 METHADONE HYDROCHLORIDE 10MG TABLET / ORAL AA 2015-08-31 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A203502-001 METHADONE HYDROCHLORIDE 5MG TABLET / ORAL AA 2015-08-31 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A203502-002 METHADONE HYDROCHLORIDE 10MG TABLET / ORAL AA 2015-08-31 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A203502-001 METHADONE HYDROCHLORIDE 5MG TABLET / ORAL AA 2015-08-31 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A203502-002 METHADONE HYDROCHLORIDE 10MG TABLET / ORAL AA 2015-08-31 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A203502-001 METHADONE HYDROCHLORIDE 5MG TABLET / ORAL AA 2015-08-31 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A203502-002 METHADONE HYDROCHLORIDE 10MG TABLET / ORAL AA 2015-08-31 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A203502-001 METHADONE HYDROCHLORIDE 5MG TABLET / ORAL AA 2015-08-31 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A203502-002 METHADONE HYDROCHLORIDE 10MG TABLET / ORAL AA 2015-08-31 782e0a99824c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 82 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Methadone Hydrochloride
Listing expiration 2026-12-31 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 13107-088-01 Methadone Hydrochloride 100 in 1 BOTTLE TABLET 100 18 13107-088-30 Methadone Hydrochloride 30 in 1 BOTTLE TABLET 30 18 13107-088-99 Methadone Hydrochloride 1000 in 1 BOTTLE TABLET 1000 18
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded METHADONE HYDROCHLORIDE ACTIVE INGREDIENT 229809935B METHADONE HYDROCHLORIDE TABLET [AUROLIFE PHARMA, LLC] 3 METHADONE ACTIVE MOIETY UC6VBE7V1Z METHADONE HYDROCHLORIDE TABLET [AUROLIFE PHARMA, LLC] 3 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U METHADONE HYDROCHLORIDE TABLET [AUROLIFE PHARMA, LLC] 3 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X METHADONE HYDROCHLORIDE TABLET [AUROLIFE PHARMA, LLC] 3 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 METHADONE HYDROCHLORIDE TABLET [AUROLIFE PHARMA, LLC] 3 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 METHADONE HYDROCHLORIDE TABLET [AUROLIFE PHARMA, LLC] 3 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ METHADONE HYDROCHLORIDE TABLET [AUROLIFE PHARMA, LLC] 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 13107-088 METHADONE HYDROCHLORIDE TABLET [AUROLIFE PHARMA, LLC] 16 Current NDC, Legacy NDC, 3 package rows 20240704_6984eb5a-57a3-4686-bc67-91bc3e7a531e.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 13107-088-01 13107008801 100 TABLET in 1 BOTTLE (13107-088-01) 100 tablet 2015-09-15 0000-00-00 No No Current 13107-088-30 13107008830 30 TABLET in 1 BOTTLE (13107-088-30) 30 tablet 2015-09-15 0000-00-00 No No Current 13107-088-99 13107008899 1000 TABLET in 1 BOTTLE (13107-088-99) 1000 tablet 2015-09-15 0000-00-00 No No Current