Home NDC 67877-116 METHADONE HYDROCHLORIDE
Product NDC 67877-116
11-digit product format 678770116
Labeler code 67877
Product ID 67877-116_20153ff4-9230-4650-88de-f63f1a43b7c0
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name METHADONE HYDROCHLORIDE
Dosage form TABLET
Route ORAL
Labeler Ascend Laboratories, LLC
Application ANDA090635
Marketing category ANDA
Marketing start 2012-01-16
Marketing end 0000-00-00
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 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 · 22 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 67877-116-01 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 67877-116-01 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 67877-116-01 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 67877-116-01 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 67877-116-01 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 67877-116-01 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 67877-116-01 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 67877-116-01 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 67877-116-01 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 67877-116-01 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 67877-116-01 367a005e9d99…383a685ebd0f…
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.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 67877-116-01 METHADONE HYDROCHLORIDE 100 in 1 BOTTLE TABLET 100 11
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded METHADONE HYDROCHLORIDE ACTIVE INGREDIENT 229809935B METHADONE HYDROCHLORIDE TABLET [ASCEND LABORATORIES, LLC] 5 METHADONE ACTIVE MOIETY UC6VBE7V1Z METHADONE HYDROCHLORIDE TABLET [ASCEND LABORATORIES, LLC] 5 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U METHADONE HYDROCHLORIDE TABLET [ASCEND LABORATORIES, LLC] 5 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 METHADONE HYDROCHLORIDE TABLET [ASCEND LABORATORIES, LLC] 5 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ METHADONE HYDROCHLORIDE TABLET [ASCEND LABORATORIES, LLC] 5 METHADONE HYDROCHLORIDE ACTIVE INGREDIENT 229809935B METHADONE HYDROCHLORIDE TABLET [AMERICAN HEALTH PACKAGING] 2 METHADONE ACTIVE MOIETY UC6VBE7V1Z METHADONE HYDROCHLORIDE TABLET [AMERICAN HEALTH PACKAGING] 2 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U METHADONE HYDROCHLORIDE TABLET [AMERICAN HEALTH PACKAGING] 2 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 METHADONE HYDROCHLORIDE TABLET [AMERICAN HEALTH PACKAGING] 2 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ METHADONE HYDROCHLORIDE TABLET [AMERICAN HEALTH PACKAGING] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 67877-116 METHADONE HYDROCHLORIDE TABLET [ASCEND LABORATORIES, LLC] 11 Legacy NDC, 1 package rows 20220615_aa8e14c1-fbfd-4e4d-b59e-2d4ae1ca815f.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 67877-116-01 67877011601 100 TABLET in 1 BOTTLE (67877-116-01) 100 tablet 2012-01-16 0000-00-00 No No Current