Home NDC 17856-0694-2 Methadone Hydrochloride
Product NDC 17856-0694
Requested package NDC 17856-0694-2
11-digit product format 178560694
Labeler code 17856
Product ID 17856-0694_e5e27338-af5a-4be9-a3dd-0902ae000cce
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Methadone Hydrochloride
Dosage form CONCENTRATE
Route ORAL
Labeler ATLANTIC BIOLOGICALS CORP.
Application ANDA040088
Marketing category ANDA
Marketing start 2019-08-28
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 2022-12-31
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 · 2 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 17856-0694 17856-0694-2 I Inactivated by FDA excluded / ndc_excluded.zip 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 17856-0694 17856-0694-2 I Inactivated by FDA excluded / ndc_excluded.zip 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 A040088-001 METHADONE HYDROCHLORIDE METHADONE HYDROCHLORIDE 10MG/ML CONCENTRATE / ORAL AA 1994-11-30
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A040088-001 AA
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 A040088-001 METHADONE HYDROCHLORIDE 10MG/ML CONCENTRATE / ORAL AA 1994-11-30 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A040088-001 METHADONE HYDROCHLORIDE 10MG/ML CONCENTRATE / ORAL AA 1994-11-30 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A040088-001 METHADONE HYDROCHLORIDE 10MG/ML CONCENTRATE / ORAL AA 1994-11-30 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A040088-001 METHADONE HYDROCHLORIDE 10MG/ML CONCENTRATE / ORAL AA 1994-11-30 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A040088-001 METHADONE HYDROCHLORIDE 10MG/ML CONCENTRATE / ORAL AA 1994-11-30 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A040088-001 METHADONE HYDROCHLORIDE 10MG/ML CONCENTRATE / ORAL AA 1994-11-30 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A040088-001 METHADONE HYDROCHLORIDE 10MG/ML CONCENTRATE / ORAL AA 1994-11-30 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A040088-001 METHADONE HYDROCHLORIDE 10MG/ML CONCENTRATE / ORAL AA 1994-11-30 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A040088-001 METHADONE HYDROCHLORIDE 10MG/ML CONCENTRATE / ORAL AA 1994-11-30 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A040088-001 METHADONE HYDROCHLORIDE 10MG/ML CONCENTRATE / ORAL AA 1994-11-30 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A040088-001 METHADONE HYDROCHLORIDE 10MG/ML CONCENTRATE / ORAL AA 1994-11-30 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A040088-001 METHADONE HYDROCHLORIDE 10MG/ML CONCENTRATE / ORAL AA 1994-11-30 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A040088-001 METHADONE HYDROCHLORIDE 10MG/ML CONCENTRATE / ORAL AA 1994-11-30 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A040088-001 METHADONE HYDROCHLORIDE 10MG/ML CONCENTRATE / ORAL AA 1994-11-30 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A040088-001 METHADONE HYDROCHLORIDE 10MG/ML CONCENTRATE / ORAL AA 1994-11-30 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A040088-001 METHADONE HYDROCHLORIDE 10MG/ML CONCENTRATE / ORAL AA 1994-11-30 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A040088-001 METHADONE HYDROCHLORIDE 10MG/ML CONCENTRATE / ORAL AA 1994-11-30 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A040088-001 METHADONE HYDROCHLORIDE 10MG/ML CONCENTRATE / ORAL AA 1994-11-30 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A040088-001 METHADONE HYDROCHLORIDE 10MG/ML CONCENTRATE / ORAL AA 1994-11-30 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A040088-001 METHADONE HYDROCHLORIDE 10MG/ML CONCENTRATE / ORAL AA 1994-11-30 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A040088-001 METHADONE HYDROCHLORIDE 10MG/ML CONCENTRATE / ORAL AA 1994-11-30 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A040088-001 METHADONE HYDROCHLORIDE 10MG/ML CONCENTRATE / ORAL AA 1994-11-30 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A040088-001 METHADONE HYDROCHLORIDE 10MG/ML CONCENTRATE / ORAL AA 1994-11-30 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A040088-001 METHADONE HYDROCHLORIDE 10MG/ML CONCENTRATE / ORAL AA 1994-11-30 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A040088-001 METHADONE HYDROCHLORIDE 10MG/ML CONCENTRATE / ORAL AA 1994-11-30 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A040088-001 METHADONE HYDROCHLORIDE 10MG/ML CONCENTRATE / ORAL AA 1994-11-30 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A040088-001 METHADONE HYDROCHLORIDE 10MG/ML CONCENTRATE / ORAL AA 1994-11-30 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A040088-001 METHADONE HYDROCHLORIDE 10MG/ML CONCENTRATE / ORAL AA 1994-11-30 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A040088-001 METHADONE HYDROCHLORIDE 10MG/ML CONCENTRATE / ORAL AA 1994-11-30 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A040088-001 METHADONE HYDROCHLORIDE 10MG/ML CONCENTRATE / ORAL AA 1994-11-30 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A040088-001 METHADONE HYDROCHLORIDE 10MG/ML CONCENTRATE / ORAL AA 1994-11-30 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A040088-001 METHADONE HYDROCHLORIDE 10MG/ML CONCENTRATE / ORAL AA 1994-11-30 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A040088-001 METHADONE HYDROCHLORIDE 10MG/ML CONCENTRATE / ORAL AA 1994-11-30 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A040088-001 METHADONE HYDROCHLORIDE 10MG/ML CONCENTRATE / ORAL AA 1994-11-30 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A040088-001 METHADONE HYDROCHLORIDE 10MG/ML CONCENTRATE / ORAL AA 1994-11-30 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A040088-001 METHADONE HYDROCHLORIDE 10MG/ML CONCENTRATE / ORAL AA 1994-11-30 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A040088-001 METHADONE HYDROCHLORIDE 10MG/ML CONCENTRATE / ORAL AA 1994-11-30 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A040088-001 METHADONE HYDROCHLORIDE 10MG/ML CONCENTRATE / ORAL AA 1994-11-30 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A040088-001 METHADONE HYDROCHLORIDE 10MG/ML CONCENTRATE / ORAL AA 1994-11-30 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A040088-001 METHADONE HYDROCHLORIDE 10MG/ML CONCENTRATE / ORAL AA 1994-11-30 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 17856-0694-1 Methadone Hydrochloride 60 in 1 BOX, UNIT-DOSE CONCENTRATE 60 3 17856-0694-1 Methadone Hydrochloride 0.25 mL in 1 SYRINGE CONCENTRATE 0.25 3 17856-0694-2 Methadone Hydrochloride 0.5 mL in 1 SYRINGE CONCENTRATE 0.5 3 17856-0694-2 Methadone Hydrochloride 60 in 1 BOX, UNIT-DOSE CONCENTRATE 60 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 17856-0694 METHADONE HYDROCHLORIDE CONCENTRATE [ATLANTIC BIOLOGICALS CORP.] 3 Legacy NDC, 4 package rows 20240522_06cc3fba-68f9-4188-a239-fbd37a9f563a.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 17856-0694-2 17856069402 60 SYRINGE in 1 BOX, UNIT-DOSE (17856-0694-2) > .5 mL in 1 SYRINGE 60 syringe 2021-01-26 0000-00-00 No No Current