Home NDC 71335-1360 METHADONE HYDROCHLORIDE
Product NDC 71335-1360
11-digit product format 713351360
Labeler code 71335
Product ID 71335-1360_6f29db41-72f8-4eee-b826-d095449170f8
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name METHADONE HYDROCHLORIDE
Dosage form TABLET
Route ORAL
Labeler Bryant Ranch Prepack
Application ANDA090635
Marketing category ANDA
Marketing start 2012-01-16
Substance METHADONE HYDROCHLORIDE
Active strength 10 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 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 A090635-001 METHADONE HYDROCHLORIDE METHADONE HYDROCHLORIDE 10MG TABLET / ORAL AA 2009-11-25 A090635-002 METHADONE HYDROCHLORIDE METHADONE HYDROCHLORIDE 5MG TABLET / ORAL AA 2020-09-22
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 A090635-001 METHADONE HYDROCHLORIDE 10MG TABLET / ORAL AA 2009-11-25 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A090635-002 METHADONE HYDROCHLORIDE 5MG TABLET / ORAL AA 2020-09-22 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A090635-001 METHADONE HYDROCHLORIDE 10MG TABLET / ORAL AA 2009-11-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A090635-002 METHADONE HYDROCHLORIDE 5MG TABLET / ORAL AA 2020-09-22 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090635-001 METHADONE HYDROCHLORIDE 10MG TABLET / ORAL AA 2009-11-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090635-002 METHADONE HYDROCHLORIDE 5MG TABLET / ORAL AA 2020-09-22 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A090635-001 METHADONE HYDROCHLORIDE 10MG TABLET / ORAL AA 2009-11-25 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A090635-002 METHADONE HYDROCHLORIDE 5MG TABLET / ORAL AA 2020-09-22 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090635-001 METHADONE HYDROCHLORIDE 10MG TABLET / ORAL AA 2009-11-25 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090635-002 METHADONE HYDROCHLORIDE 5MG TABLET / ORAL AA 2020-09-22 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090635-001 METHADONE HYDROCHLORIDE 10MG TABLET / ORAL AA 2009-11-25 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090635-002 METHADONE HYDROCHLORIDE 5MG TABLET / ORAL AA 2020-09-22 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090635-001 METHADONE HYDROCHLORIDE 10MG TABLET / ORAL AA 2009-11-25 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090635-002 METHADONE HYDROCHLORIDE 5MG TABLET / ORAL AA 2020-09-22 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090635-001 METHADONE HYDROCHLORIDE 10MG TABLET / ORAL AA 2009-11-25 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090635-002 METHADONE HYDROCHLORIDE 5MG TABLET / ORAL AA 2020-09-22 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A090635-001 METHADONE HYDROCHLORIDE 10MG TABLET / ORAL AA 2009-11-25 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A090635-002 METHADONE HYDROCHLORIDE 5MG TABLET / ORAL AA 2020-09-22 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A090635-001 METHADONE HYDROCHLORIDE 10MG TABLET / ORAL AA 2009-11-25 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A090635-002 METHADONE HYDROCHLORIDE 5MG TABLET / ORAL AA 2020-09-22 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A090635-001 METHADONE HYDROCHLORIDE 10MG TABLET / ORAL AA 2009-11-25 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A090635-002 METHADONE HYDROCHLORIDE 5MG TABLET / ORAL AA 2020-09-22 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A090635-001 METHADONE HYDROCHLORIDE 10MG TABLET / ORAL AA 2009-11-25 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A090635-002 METHADONE HYDROCHLORIDE 5MG TABLET / ORAL AA 2020-09-22 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A090635-001 METHADONE HYDROCHLORIDE 10MG TABLET / ORAL AA 2009-11-25 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A090635-002 METHADONE HYDROCHLORIDE 5MG TABLET / ORAL AA 2020-09-22 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A090635-001 METHADONE HYDROCHLORIDE 10MG TABLET / ORAL AA 2009-11-25 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A090635-002 METHADONE HYDROCHLORIDE 5MG TABLET / ORAL AA 2020-09-22 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A090635-001 METHADONE HYDROCHLORIDE 10MG TABLET / ORAL AA 2009-11-25 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A090635-002 METHADONE HYDROCHLORIDE 5MG TABLET / ORAL AA 2020-09-22 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A090635-001 METHADONE HYDROCHLORIDE 10MG TABLET / ORAL AA 2009-11-25 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A090635-002 METHADONE HYDROCHLORIDE 5MG TABLET / ORAL AA 2020-09-22 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A090635-001 METHADONE HYDROCHLORIDE 10MG TABLET / ORAL AA 2009-11-25 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A090635-002 METHADONE HYDROCHLORIDE 5MG TABLET / ORAL AA 2020-09-22 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A090635-001 METHADONE HYDROCHLORIDE 10MG TABLET / ORAL AA 2009-11-25 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A090635-002 METHADONE HYDROCHLORIDE 5MG TABLET / ORAL AA 2020-09-22 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A090635-001 METHADONE HYDROCHLORIDE 10MG TABLET / ORAL AA 2009-11-25 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A090635-001 METHADONE HYDROCHLORIDE 10MG TABLET / ORAL AA 2009-11-25 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A090635-002 METHADONE HYDROCHLORIDE 5MG TABLET / ORAL AA 2020-09-22 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A090635-001 METHADONE HYDROCHLORIDE 10MG TABLET / ORAL AA 2009-11-25 782e0a99824c…
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 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength METHADONE HYDROCHLORIDE 10 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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 864706 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 71335-1360-0 METHADONE HYDROCHLORIDE 168 in 1 BOTTLE TABLET 168 4 71335-1360-1 METHADONE HYDROCHLORIDE 15 in 1 BOTTLE TABLET 15 4 71335-1360-2 METHADONE HYDROCHLORIDE 30 in 1 BOTTLE TABLET 30 4 71335-1360-3 METHADONE HYDROCHLORIDE 90 in 1 BOTTLE TABLET 90 4 71335-1360-4 METHADONE HYDROCHLORIDE 120 in 1 BOTTLE TABLET 120 4 71335-1360-5 METHADONE HYDROCHLORIDE 180 in 1 BOTTLE TABLET 180 4 71335-1360-6 METHADONE HYDROCHLORIDE 60 in 1 BOTTLE TABLET 60 4 71335-1360-7 METHADONE HYDROCHLORIDE 28 in 1 BOTTLE TABLET 28 4 71335-1360-8 METHADONE HYDROCHLORIDE 112 in 1 BOTTLE TABLET 112 4 71335-1360-9 METHADONE HYDROCHLORIDE 56 in 1 BOTTLE TABLET 56 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 71335-1360 METHADONE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK] 4 Current NDC, Legacy NDC, 10 package rows 20231107_7a8635fe-6183-4cda-9029-50e4e6dd5832.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 · 2 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 71335-1360-0 71335136000 168 TABLET in 1 BOTTLE (71335-1360-0) 168 tablet 2022-09-28 0000-00-00 No No Current 71335-1360-1 71335136001 15 TABLET in 1 BOTTLE (71335-1360-1) 15 tablet 2022-09-28 0000-00-00 No No Current 71335-1360-2 71335136002 30 TABLET in 1 BOTTLE (71335-1360-2) 30 tablet 2019-10-01 0000-00-00 No No Current 71335-1360-3 71335136003 90 TABLET in 1 BOTTLE (71335-1360-3) 90 tablet 2020-08-14 0000-00-00 No No Current 71335-1360-4 71335136004 120 TABLET in 1 BOTTLE (71335-1360-4) 120 tablet 2022-09-28 0000-00-00 No No Current 71335-1360-5 71335136005 180 TABLET in 1 BOTTLE (71335-1360-5) 180 tablet 2022-09-28 0000-00-00 No No Current 71335-1360-6 71335136006 60 TABLET in 1 BOTTLE (71335-1360-6) 60 tablet 2022-09-28 0000-00-00 No No Current 71335-1360-7 71335136007 28 TABLET in 1 BOTTLE (71335-1360-7) 28 tablet 2022-09-28 0000-00-00 No No Current 71335-1360-8 71335136008 112 TABLET in 1 BOTTLE (71335-1360-8) 112 tablet 2022-09-28 0000-00-00 No No Current 71335-1360-9 71335136009 56 TABLET in 1 BOTTLE (71335-1360-9) 56 tablet 2022-09-28 0000-00-00 No No Current