Home NDC 17478-380 Methadone Hydrochloride
Product NDC 17478-380
11-digit product format 174780380
Labeler code 17478
Product ID 17478-380_3f104296-cbe9-4e21-999c-fec45759ae73
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Methadone Hydrochloride
Dosage form INJECTION, SOLUTION
Route INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS
Labeler Akorn
Application ANDA208306
Marketing category ANDA
Marketing start 2017-10-30
Marketing end 0000-00-00
Substance METHADONE HYDROCHLORIDE
Active strength 10 mg/mL
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 · 30 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 17478-380-20 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 17478-380-20 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 17478-380-20 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 17478-380-20 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 17478-380-20 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 17478-380-20 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 17478-380-20 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 17478-380-20 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 17478-380-20 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 17478-380-20 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 17478-380-20 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 17478-380-20 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 excluded product product 8af77b9d5b6f…d9bbb34c5368…2024-05-28 21:12 UTC · source 2024-05-28 excluded package package 17478-380-20 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 excluded product product 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 17478-380-20 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 excluded product product 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 17478-380-20 1332a3947898…d4bfe170f9cd…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A208306-001 METHADONE HYDROCHLORIDE METHADONE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP 2017-10-27
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A208306-001 AP
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 · 41 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 A208306-001 METHADONE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP 2017-10-27 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A208306-001 METHADONE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP 2017-10-27 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A208306-001 METHADONE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP 2017-10-27 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A208306-001 METHADONE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP 2017-10-27 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A208306-001 METHADONE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP 2017-10-27 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A208306-001 METHADONE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP 2017-10-27 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A208306-001 METHADONE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP 2017-10-27 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A208306-001 METHADONE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP 2017-10-27 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A208306-001 METHADONE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP 2017-10-27 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A208306-001 METHADONE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP 2017-10-27 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A208306-001 METHADONE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP 2017-10-27 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A208306-001 METHADONE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP 2017-10-27 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A208306-001 METHADONE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP 2017-10-27 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A208306-001 METHADONE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP 2017-10-27 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A208306-001 METHADONE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP 2017-10-27 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A208306-001 METHADONE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP 2017-10-27 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A208306-001 METHADONE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP 2017-10-27 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A208306-001 METHADONE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP 2017-10-27 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A208306-001 METHADONE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP 2017-10-27 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A208306-001 METHADONE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP 2017-10-27 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A208306-001 METHADONE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP 2017-10-27 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A208306-001 METHADONE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP 2017-10-27 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A208306-001 METHADONE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP 2017-10-27 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A208306-001 METHADONE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP 2017-10-27 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A208306-001 METHADONE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP 2017-10-27 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A208306-001 METHADONE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP 2017-10-27 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A208306-001 METHADONE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP 2017-10-27 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A208306-001 METHADONE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP 2017-10-27 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A208306-001 METHADONE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP 2017-10-27 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A208306-001 METHADONE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP 2017-10-27 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A208306-001 METHADONE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP 2017-10-27 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A208306-001 METHADONE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP 2017-10-27 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A208306-001 METHADONE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP 2017-10-27 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A208306-001 METHADONE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP 2017-10-27 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A208306-001 METHADONE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP 2017-10-27 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A208306-001 METHADONE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP 2017-10-27 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A208306-001 METHADONE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP 2017-10-27 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A208306-001 METHADONE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP 2017-10-27 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A208306-001 METHADONE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP 2017-10-27 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A208306-001 METHADONE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP 2017-10-27 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 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 17478-380-20 Methadone Hydrochloride 20 mL in 1 VIAL, MULTI-DOSE INJECTION, SOLUTION 20 9
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 17478-380 METHADONE HYDROCHLORIDE INJECTION, SOLUTION [AKORN
] 9 Legacy NDC, 1 package rows 20221208_cedfe8fa-b57d-4cb1-a047-0af5a8ef199e.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 17478-380-20 17478038020 20 mL in 1 VIAL, MULTI-DOSE (17478-380-20) 20 ml 2017-10-30 0000-00-00 No No Current