Home NDC 71335-0493 Methadone Hydrochloride
Product NDC 71335-0493
11-digit product format 713350493
Labeler code 71335
Product ID 71335-0493_cc79daec-2430-4d17-a37d-5a7ff5bfd883
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Methadone Hydrochloride
Dosage form TABLET
Route ORAL
Labeler Bryant Ranch Prepack
Application ANDA203502
Marketing category ANDA
Marketing start 2015-09-15
Marketing end 0000-00-00
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 2023-12-31
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 32 matching rows.
View current auxiliary records. · View the auxiliary file history.
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 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 · 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 A203502-001 METHADONE HYDROCHLORIDE 5MG TABLET / ORAL AA 2015-08-31 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A203502-002 METHADONE HYDROCHLORIDE 10MG TABLET / ORAL AA 2015-08-31 caaa826d4ba7…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…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 84 observed states.
FDA-Initiated Inactive NDC Indexing# NDC, Effective, Related label table NDC Effective Related label 71335-0493-1 2024-08-20 These highlights do not include all the information needed to use Methadone Hydrochloride Tablets, USP safely and effectively. See full prescribing information for Methadone Hydrochloride Tablets, USP. Methadone Hydrochloride Tablets, USP, for oral use CII Initial U.S. Approval: 1947 71335-0493-2 2024-08-20 These highlights do not include all the information needed to use Methadone Hydrochloride Tablets, USP safely and effectively. See full prescribing information for Methadone Hydrochloride Tablets, USP. Methadone Hydrochloride Tablets, USP, for oral use CII Initial U.S. Approval: 1947 71335-0493-3 2024-08-20 These highlights do not include all the information needed to use Methadone Hydrochloride Tablets, USP safely and effectively. See full prescribing information for Methadone Hydrochloride Tablets, USP. Methadone Hydrochloride Tablets, USP, for oral use CII Initial U.S. Approval: 1947 71335-0493-4 2024-08-20 These highlights do not include all the information needed to use Methadone Hydrochloride Tablets, USP safely and effectively. See full prescribing information for Methadone Hydrochloride Tablets, USP. Methadone Hydrochloride Tablets, USP, for oral use CII Initial U.S. Approval: 1947 71335-0493-5 2024-08-20 These highlights do not include all the information needed to use Methadone Hydrochloride Tablets, USP safely and effectively. See full prescribing information for Methadone Hydrochloride Tablets, USP. Methadone Hydrochloride Tablets, USP, for oral use CII Initial U.S. Approval: 1947 71335-0493-6 2024-08-20 These highlights do not include all the information needed to use Methadone Hydrochloride Tablets, USP safely and effectively. See full prescribing information for Methadone Hydrochloride Tablets, USP. Methadone Hydrochloride Tablets, USP, for oral use CII Initial U.S. Approval: 1947 71335-0493-7 2024-08-20 These highlights do not include all the information needed to use Methadone Hydrochloride Tablets, USP safely and effectively. See full prescribing information for Methadone Hydrochloride Tablets, USP. Methadone Hydrochloride Tablets, USP, for oral use CII Initial U.S. Approval: 1947 71335-0493-1 2024-01-30 These highlights do not include all the information needed to use Methadone Hydrochloride Tablets, USP safely and effectively. See full prescribing information for Methadone Hydrochloride Tablets, USP. Methadone Hydrochloride Tablets, USP, for oral use CII Initial U.S. Approval: 1947 71335-0493-2 2024-01-30 These highlights do not include all the information needed to use Methadone Hydrochloride Tablets, USP safely and effectively. See full prescribing information for Methadone Hydrochloride Tablets, USP. Methadone Hydrochloride Tablets, USP, for oral use CII Initial U.S. Approval: 1947 71335-0493-3 2024-01-30 These highlights do not include all the information needed to use Methadone Hydrochloride Tablets, USP safely and effectively. See full prescribing information for Methadone Hydrochloride Tablets, USP. Methadone Hydrochloride Tablets, USP, for oral use CII Initial U.S. Approval: 1947 71335-0493-4 2024-01-30 These highlights do not include all the information needed to use Methadone Hydrochloride Tablets, USP safely and effectively. See full prescribing information for Methadone Hydrochloride Tablets, USP. Methadone Hydrochloride Tablets, USP, for oral use CII Initial U.S. Approval: 1947 71335-0493-5 2024-01-30 These highlights do not include all the information needed to use Methadone Hydrochloride Tablets, USP safely and effectively. See full prescribing information for Methadone Hydrochloride Tablets, USP. Methadone Hydrochloride Tablets, USP, for oral use CII Initial U.S. Approval: 1947 71335-0493-6 2024-01-30 These highlights do not include all the information needed to use Methadone Hydrochloride Tablets, USP safely and effectively. See full prescribing information for Methadone Hydrochloride Tablets, USP. Methadone Hydrochloride Tablets, USP, for oral use CII Initial U.S. Approval: 1947 71335-0493-7 2024-01-30 These highlights do not include all the information needed to use Methadone Hydrochloride Tablets, USP safely and effectively. See full prescribing information for Methadone Hydrochloride Tablets, USP. Methadone Hydrochloride Tablets, USP, for oral use CII Initial U.S. Approval: 1947
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 71335-0493 METHADONE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK] 8 Legacy NDC 20240822_cc79daec-2430-4d17-a37d-5a7ff5bfd883.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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 71335-0493-1 71335049301 90 TABLET in 1 BOTTLE (71335-0493-1) 90 tablet 2017-07-18 0000-00-00 No No Current 71335-0493-2 71335049302 30 TABLET in 1 BOTTLE (71335-0493-2) 30 tablet 2017-07-18 0000-00-00 No No Current 71335-0493-3 71335049303 120 TABLET in 1 BOTTLE (71335-0493-3) 120 tablet 2017-07-18 0000-00-00 No No Current 71335-0493-4 71335049304 112 TABLET in 1 BOTTLE (71335-0493-4) 112 tablet 2017-07-18 0000-00-00 No No Current 71335-0493-5 71335049305 60 TABLET in 1 BOTTLE (71335-0493-5) 60 tablet 2017-07-18 0000-00-00 No No Current 71335-0493-6 71335049306 180 TABLET in 1 BOTTLE (71335-0493-6) 180 tablet 2017-07-18 0000-00-00 No No Current 71335-0493-7 71335049307 28 TABLET in 1 BOTTLE (71335-0493-7) 28 tablet 2017-07-18 0000-00-00 No No Current