Home NDC 60687-214-01 Methadone Hydrochloride
Product NDC 60687-214
Requested package NDC 60687-214-01
11-digit product format 606870214
Labeler code 60687
Product ID 60687-214_e2716c69-73f8-55bd-e053-2a95a90a1e44
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Methadone Hydrochloride
Dosage form TABLET
Route ORAL
Labeler American Health Packaging
Application ANDA203502
Marketing category ANDA
Marketing start 2016-12-20
Marketing end 2023-04-30
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 0000-00-00
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 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…
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.
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 60687-214-01 60687021401 100 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-214-01) > 1 TABLET in 1 BLISTER PACK (60687-214-11) 100 blister pack 2016-12-20 2023-04-30 No No Current