Home NDC 17856-0392-6 Methadone Hydrochloride
Product NDC 17856-0392
Requested package NDC 17856-0392-6
11-digit product format 178560392
Labeler code 17856
Product ID 17856-0392_36b0bbb0-eb9e-7547-e063-6394a90a25f4
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Methadone Hydrochloride
Dosage form CONCENTRATE
Route ORAL
Labeler ATLANTIC BIOLOGICALS CORP.
Application ANDA040180
Marketing category ANDA
Marketing start 2019-05-14
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 2026-12-31
Current FDA listing Yes 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 A040180-001 METHADONE HYDROCHLORIDE METHADONE HYDROCHLORIDE 10MG/ML CONCENTRATE / ORAL AA 1998-04-30
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A040180-001 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 A040180-001 METHADONE HYDROCHLORIDE 10MG/ML CONCENTRATE / ORAL AA 1998-04-30 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A040180-001 METHADONE HYDROCHLORIDE 10MG/ML CONCENTRATE / ORAL AA 1998-04-30 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A040180-001 METHADONE HYDROCHLORIDE 10MG/ML CONCENTRATE / ORAL AA 1998-04-30 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A040180-001 METHADONE HYDROCHLORIDE 10MG/ML CONCENTRATE / ORAL AA 1998-04-30 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A040180-001 METHADONE HYDROCHLORIDE 10MG/ML CONCENTRATE / ORAL AA 1998-04-30 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A040180-001 METHADONE HYDROCHLORIDE 10MG/ML CONCENTRATE / ORAL AA 1998-04-30 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A040180-001 METHADONE HYDROCHLORIDE 10MG/ML CONCENTRATE / ORAL AA 1998-04-30 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A040180-001 METHADONE HYDROCHLORIDE 10MG/ML CONCENTRATE / ORAL AA 1998-04-30 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A040180-001 METHADONE HYDROCHLORIDE 10MG/ML CONCENTRATE / ORAL AA 1998-04-30 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A040180-001 METHADONE HYDROCHLORIDE 10MG/ML CONCENTRATE / ORAL AA 1998-04-30 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A040180-001 METHADONE HYDROCHLORIDE 10MG/ML CONCENTRATE / ORAL AA 1998-04-30 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A040180-001 METHADONE HYDROCHLORIDE 10MG/ML CONCENTRATE / ORAL AA 1998-04-30 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A040180-001 METHADONE HYDROCHLORIDE 10MG/ML CONCENTRATE / ORAL AA 1998-04-30 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A040180-001 METHADONE HYDROCHLORIDE 10MG/ML CONCENTRATE / ORAL AA 1998-04-30 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A040180-001 METHADONE HYDROCHLORIDE 10MG/ML CONCENTRATE / ORAL AA 1998-04-30 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A040180-001 METHADONE HYDROCHLORIDE 10MG/ML CONCENTRATE / ORAL AA 1998-04-30 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A040180-001 METHADONE HYDROCHLORIDE 10MG/ML CONCENTRATE / ORAL AA 1998-04-30 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A040180-001 METHADONE HYDROCHLORIDE 10MG/ML CONCENTRATE / ORAL AA 1998-04-30 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A040180-001 METHADONE HYDROCHLORIDE 10MG/ML CONCENTRATE / ORAL AA 1998-04-30 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A040180-001 METHADONE HYDROCHLORIDE 10MG/ML CONCENTRATE / ORAL AA 1998-04-30 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A040180-001 METHADONE HYDROCHLORIDE 10MG/ML CONCENTRATE / ORAL AA 1998-04-30 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A040180-001 METHADONE HYDROCHLORIDE 10MG/ML CONCENTRATE / ORAL AA 1998-04-30 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A040180-001 METHADONE HYDROCHLORIDE 10MG/ML CONCENTRATE / ORAL AA 1998-04-30 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A040180-001 METHADONE HYDROCHLORIDE 10MG/ML CONCENTRATE / ORAL AA 1998-04-30 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A040180-001 METHADONE HYDROCHLORIDE 10MG/ML CONCENTRATE / ORAL AA 1998-04-30 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A040180-001 METHADONE HYDROCHLORIDE 10MG/ML CONCENTRATE / ORAL AA 1998-04-30 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A040180-001 METHADONE HYDROCHLORIDE 10MG/ML CONCENTRATE / ORAL AA 1998-04-30 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A040180-001 METHADONE HYDROCHLORIDE 10MG/ML CONCENTRATE / ORAL AA 1998-04-30 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A040180-001 METHADONE HYDROCHLORIDE 10MG/ML CONCENTRATE / ORAL AA 1998-04-30 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A040180-001 METHADONE HYDROCHLORIDE 10MG/ML CONCENTRATE / ORAL AA 1998-04-30 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A040180-001 METHADONE HYDROCHLORIDE 10MG/ML CONCENTRATE / ORAL AA 1998-04-30 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A040180-001 METHADONE HYDROCHLORIDE 10MG/ML CONCENTRATE / ORAL AA 1998-04-30 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A040180-001 METHADONE HYDROCHLORIDE 10MG/ML CONCENTRATE / ORAL AA 1998-04-30 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A040180-001 METHADONE HYDROCHLORIDE 10MG/ML CONCENTRATE / ORAL AA 1998-04-30 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A040180-001 METHADONE HYDROCHLORIDE 10MG/ML CONCENTRATE / ORAL AA 1998-04-30 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A040180-001 METHADONE HYDROCHLORIDE 10MG/ML CONCENTRATE / ORAL AA 1998-04-30 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A040180-001 METHADONE HYDROCHLORIDE 10MG/ML CONCENTRATE / ORAL AA 1998-04-30 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A040180-001 METHADONE HYDROCHLORIDE 10MG/ML CONCENTRATE / ORAL AA 1998-04-30 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A040180-001 METHADONE HYDROCHLORIDE 10MG/ML CONCENTRATE / ORAL AA 1998-04-30 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A040180-001 METHADONE HYDROCHLORIDE 10MG/ML CONCENTRATE / ORAL AA 1998-04-30 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Methadone Hydrochloride
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength METHADONE HYDROCHLORIDE 10 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 229809935B Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 991147 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# NDC, Effective, Related label table NDC Effective Related label 17856-0392-1 2024-05-20 0392 - Methadone Hydrochloride Oral Concentrate USP CII (Dye-Free, Sugar-Free, Unflavored) and Methadone Hydrochloride Oral Concentrate USP CII (Cherry) FOR ORAL USE ONLY Rx Only 17856-0392-1 2024-05-20 0392 - Methadone Hydrochloride Oral Concentrate USP CII (Dye-Free, Sugar-Free, Unflavored) and Methadone Hydrochloride Oral Concentrate USP CII (Cherry) FOR ORAL USE ONLY Rx Only 17856-0392-3 2024-05-20 0392 - Methadone Hydrochloride Oral Concentrate USP CII (Dye-Free, Sugar-Free, Unflavored) and Methadone Hydrochloride Oral Concentrate USP CII (Cherry) FOR ORAL USE ONLY Rx Only 17856-0392-3 2024-05-20 0392 - Methadone Hydrochloride Oral Concentrate USP CII (Dye-Free, Sugar-Free, Unflavored) and Methadone Hydrochloride Oral Concentrate USP CII (Cherry) FOR ORAL USE ONLY Rx Only 17856-0392-7 2024-05-20 0392 - Methadone Hydrochloride Oral Concentrate USP CII (Dye-Free, Sugar-Free, Unflavored) and Methadone Hydrochloride Oral Concentrate USP CII (Cherry) FOR ORAL USE ONLY Rx Only 17856-0392-7 2024-05-20 0392 - Methadone Hydrochloride Oral Concentrate USP CII (Dye-Free, Sugar-Free, Unflavored) and Methadone Hydrochloride Oral Concentrate USP CII (Cherry) FOR ORAL USE ONLY Rx Only 17856-0392-1 2024-01-30 0392 - Methadone Hydrochloride Oral Concentrate USP CII (Dye-Free, Sugar-Free, Unflavored) and Methadone Hydrochloride Oral Concentrate USP CII (Cherry) FOR ORAL USE ONLY Rx Only 17856-0392-1 2024-01-30 0392 - Methadone Hydrochloride Oral Concentrate USP CII (Dye-Free, Sugar-Free, Unflavored) and Methadone Hydrochloride Oral Concentrate USP CII (Cherry) FOR ORAL USE ONLY Rx Only 17856-0392-3 2024-01-30 0392 - Methadone Hydrochloride Oral Concentrate USP CII (Dye-Free, Sugar-Free, Unflavored) and Methadone Hydrochloride Oral Concentrate USP CII (Cherry) FOR ORAL USE ONLY Rx Only 17856-0392-3 2024-01-30 0392 - Methadone Hydrochloride Oral Concentrate USP CII (Dye-Free, Sugar-Free, Unflavored) and Methadone Hydrochloride Oral Concentrate USP CII (Cherry) FOR ORAL USE ONLY Rx Only 17856-0392-7 2024-01-30 0392 - Methadone Hydrochloride Oral Concentrate USP CII (Dye-Free, Sugar-Free, Unflavored) and Methadone Hydrochloride Oral Concentrate USP CII (Cherry) FOR ORAL USE ONLY Rx Only 17856-0392-7 2024-01-30 0392 - Methadone Hydrochloride Oral Concentrate USP CII (Dye-Free, Sugar-Free, Unflavored) and Methadone Hydrochloride Oral Concentrate USP CII (Cherry) FOR ORAL USE ONLY Rx Only
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 17856-0392-1 Methadone Hydrochloride 60 in 1 BOX, UNIT-DOSE CONCENTRATE 60 6 17856-0392-1 Methadone Hydrochloride 0.5 mL in 1 SYRINGE CONCENTRATE 0.5 6 17856-0392-2 Methadone Hydrochloride 60 in 1 BOX, UNIT-DOSE CONCENTRATE 60 6 17856-0392-3 Methadone Hydrochloride 72 in 1 BOX, UNIT-DOSE CONCENTRATE 72 6 17856-0392-4 Methadone Hydrochloride 2.5 mL in 1 CUP, UNIT-DOSE CONCENTRATE 2.5 6 17856-0392-5 Methadone Hydrochloride 1 mL in 1 SYRINGE CONCENTRATE 1 6 17856-0392-6 Methadone Hydrochloride 0.5 mL in 1 SYRINGE CONCENTRATE 0.5 6 17856-0392-6 Methadone Hydrochloride 1 in 1 BAG CONCENTRATE 1 6 17856-0392-7 Methadone Hydrochloride 5 in 1 SYRINGE CONCENTRATE 5 6 17856-0392-8 Methadone Hydrochloride 1 mL in 1 SYRINGE CONCENTRATE 1 6 17856-0392-8 Methadone Hydrochloride 1 in 1 BAG CONCENTRATE 1 6 17856-0392-9 Methadone Hydrochloride 1 in 1 BAG CONCENTRATE 1 6 17856-0392-9 Methadone Hydrochloride 2.5 mL in 1 SYRINGE CONCENTRATE 2.5 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 17856-0392 METHADONE HYDROCHLORIDE CONCENTRATE [ATLANTIC BIOLOGICALS CORP.] 5 Current NDC, Legacy NDC, 13 package rows 20240522_d7b30c78-c531-4dc5-9552-d68daa3210d1.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 Sample Exclude flag Status 17856-0392-6 17856039206 1 SYRINGE in 1 BAG (17856-0392-6) / .5 mL in 1 SYRINGE 1 syringe 2025-05-30 No No Current