Home NDC 17856-3556 Methadone Hydrochloride
Product NDC 17856-3556
11-digit product format 178563556
Labeler code 17856
Product ID 17856-3556_eee58a0e-2c67-428b-9f8b-effa9888d0a5
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Methadone Hydrochloride
Dosage form SOLUTION
Route ORAL
Labeler ATLANTIC BIOLOGICALS CORP.
Application ANDA087997
Marketing category ANDA
Marketing start 1982-08-30
Marketing end 0000-00-00
Substance METHADONE HYDROCHLORIDE
Active strength 10 mg/5mL
Pharmacologic classes Full Opioid Agonists [MoA],Opioid Agonist [EPC]
DEA schedule CII
NDC exclude flag No
Listing certified through 2021-12-31
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 · 36 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Code Status Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 17856-3556-5 I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 17856-3556-6 I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 17856-3556-5 I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 17856-3556-6 I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 17856-3556-5 I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 17856-3556-6 I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 17856-3556-5 I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 17856-3556-6 I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 17856-3556-5 I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 17856-3556-6 I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 17856-3556-5 I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 17856-3556-6 I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product U Excluded because listing certification expired 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 17856-3556-6 U Excluded because listing certification expired 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 17856-3556-5 U Excluded because listing certification expired 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product U Excluded because listing certification expired ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 17856-3556-6 U Excluded because listing certification expired ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 17856-3556-5 U Excluded because listing certification expired ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product U Excluded because listing certification expired 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 17856-3556-6 U Excluded because listing certification expired 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 17856-3556-5 U Excluded because listing certification expired 0efc9e666f02…f202fb6c5f17…2022-08-30 03:57 UTC · source 2022-08-29 excluded product product I Inactivated by FDA fb8cb913e6d1…eb8c232b6be0…2022-08-30 03:57 UTC · source 2022-08-29 excluded package package 17856-3556-6 I Inactivated by FDA fb8cb913e6d1…eb8c232b6be0…2022-08-30 03:57 UTC · source 2022-08-29 excluded package package 17856-3556-5 I Inactivated by FDA fb8cb913e6d1…eb8c232b6be0…2022-04-09 23:13 UTC · source 2022-04-08 excluded product product I Inactivated by FDA 86f5da6cb304…a595104c45d7…2022-04-09 23:13 UTC · source 2022-04-08 excluded package package 17856-3556-6 I Inactivated by FDA 86f5da6cb304…a595104c45d7…2022-04-09 23:13 UTC · source 2022-04-08 excluded package package 17856-3556-5 I Inactivated by FDA 86f5da6cb304…a595104c45d7…2022-04-04 05:40 UTC · source 2022-04-01 excluded product product I Inactivated by FDA bd6a592717d7…303034d00443…2022-04-04 05:40 UTC · source 2022-04-01 excluded package package 17856-3556-6 I Inactivated by FDA bd6a592717d7…303034d00443…2022-04-04 05:40 UTC · source 2022-04-01 excluded package package 17856-3556-5 I Inactivated by FDA bd6a592717d7…303034d00443…
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 A087997-001 METHADONE HYDROCHLORIDE METHADONE HYDROCHLORIDE 10MG/5ML SOLUTION / ORAL AA RLD, RS 1982-08-30
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A087997-001 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 A087997-001 METHADONE HYDROCHLORIDE 10MG/5ML SOLUTION / ORAL AA RLD, RS 1982-08-30 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A087997-001 METHADONE HYDROCHLORIDE 10MG/5ML SOLUTION / ORAL AA RLD, RS 1982-08-30 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A087997-001 METHADONE HYDROCHLORIDE 10MG/5ML SOLUTION / ORAL AA RLD, RS 1982-08-30 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A087997-001 METHADONE HYDROCHLORIDE 10MG/5ML SOLUTION / ORAL AA RLD, RS 1982-08-30 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A087997-001 METHADONE HYDROCHLORIDE 10MG/5ML SOLUTION / ORAL AA RLD, RS 1982-08-30 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A087997-001 METHADONE HYDROCHLORIDE 10MG/5ML SOLUTION / ORAL AA RLD, RS 1982-08-30 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A087997-001 METHADONE HYDROCHLORIDE 10MG/5ML SOLUTION / ORAL AA RLD, RS 1982-08-30 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A087997-001 METHADONE HYDROCHLORIDE 10MG/5ML SOLUTION / ORAL AA RLD, RS 1982-08-30 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A087997-001 METHADONE HYDROCHLORIDE 10MG/5ML SOLUTION / ORAL AA RLD, RS 1982-08-30 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A087997-001 METHADONE HYDROCHLORIDE 10MG/5ML SOLUTION / ORAL AA RLD, RS 1982-08-30 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A087997-001 METHADONE HYDROCHLORIDE 10MG/5ML SOLUTION / ORAL AA RLD, RS 1982-08-30 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A087997-001 METHADONE HYDROCHLORIDE 10MG/5ML SOLUTION / ORAL AA RLD, RS 1982-08-30 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A087997-001 METHADONE HYDROCHLORIDE 10MG/5ML SOLUTION / ORAL AA RLD, RS 1982-08-30 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A087997-001 METHADONE HYDROCHLORIDE 10MG/5ML SOLUTION / ORAL AA RLD, RS 1982-08-30 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A087997-001 METHADONE HYDROCHLORIDE 10MG/5ML SOLUTION / ORAL AA RLD, RS 1982-08-30 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A087997-001 METHADONE HYDROCHLORIDE 10MG/5ML SOLUTION / ORAL AA RLD, RS 1982-08-30 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A087997-001 METHADONE HYDROCHLORIDE 10MG/5ML SOLUTION / ORAL AA RLD, RS 1982-08-30 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A087997-001 METHADONE HYDROCHLORIDE 10MG/5ML SOLUTION / ORAL AA RS 1982-08-30 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A087997-001 METHADONE HYDROCHLORIDE 10MG/5ML SOLUTION / ORAL AA RLD, RS 1982-08-30 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A087997-001 METHADONE HYDROCHLORIDE 10MG/5ML SOLUTION / ORAL AA RLD, RS 1982-08-30 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A087997-001 METHADONE HYDROCHLORIDE 10MG/5ML SOLUTION / ORAL AA RS 1982-08-30 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A087997-001 METHADONE HYDROCHLORIDE 10MG/5ML SOLUTION / ORAL AA RS 1982-08-30 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A087997-001 METHADONE HYDROCHLORIDE 10MG/5ML SOLUTION / ORAL AA RS 1982-08-30 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A087997-001 METHADONE HYDROCHLORIDE 10MG/5ML SOLUTION / ORAL AA RS 1982-08-30 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A087997-001 METHADONE HYDROCHLORIDE 10MG/5ML SOLUTION / ORAL AA RS 1982-08-30 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A087997-001 METHADONE HYDROCHLORIDE 10MG/5ML SOLUTION / ORAL AA RS 1982-08-30 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A087997-001 METHADONE HYDROCHLORIDE 10MG/5ML SOLUTION / ORAL AA RS 1982-08-30 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A087997-001 METHADONE HYDROCHLORIDE 10MG/5ML SOLUTION / ORAL AA RLD, RS 1982-08-30 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A087997-001 METHADONE HYDROCHLORIDE 10MG/5ML SOLUTION / ORAL AA RLD, RS 1982-08-30 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A087997-001 METHADONE HYDROCHLORIDE 10MG/5ML SOLUTION / ORAL AA RLD, RS 1982-08-30 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A087997-001 METHADONE HYDROCHLORIDE 10MG/5ML SOLUTION / ORAL AA RLD, RS 1982-08-30 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A087997-001 METHADONE HYDROCHLORIDE 10MG/5ML SOLUTION / ORAL AA RLD, RS 1982-08-30 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A087997-001 METHADONE HYDROCHLORIDE 10MG/5ML SOLUTION / ORAL AA RLD, RS 1982-08-30 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A087997-001 METHADONE HYDROCHLORIDE 10MG/5ML SOLUTION / ORAL AA RLD, RS 1982-08-30 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A087997-001 METHADONE HYDROCHLORIDE 10MG/5ML SOLUTION / ORAL AA RLD, RS 1982-08-30 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A087997-001 METHADONE HYDROCHLORIDE 10MG/5ML SOLUTION / ORAL AA RLD, RS 1982-08-30 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A087997-001 METHADONE HYDROCHLORIDE 10MG/5ML SOLUTION / ORAL AA RLD, RS 1982-08-30 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A087997-001 METHADONE HYDROCHLORIDE 10MG/5ML SOLUTION / ORAL AA RLD, RS 1982-08-30 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A087997-001 METHADONE HYDROCHLORIDE 10MG/5ML SOLUTION / ORAL AA RLD, RS 1982-08-30 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A087997-001 METHADONE HYDROCHLORIDE 10MG/5ML SOLUTION / ORAL AA RLD, RS 1982-08-30 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# NDC, Effective, Related label table NDC Effective Related label 17856-3556-5 2025-01-30 These highlights do not include all the information needed to use METHADONE HYDROCHLORIDE ORAL SOLUTION safely and effectively. See full prescribing information for METHADONE HYDROCHLORIDE ORAL SOLUTION. METHADONE HYDROCHLORIDE oral solution, for oral use CII Initial U.S. Approval: 1947 17856-3556-6 2025-01-30 These highlights do not include all the information needed to use METHADONE HYDROCHLORIDE ORAL SOLUTION safely and effectively. See full prescribing information for METHADONE HYDROCHLORIDE ORAL SOLUTION. METHADONE HYDROCHLORIDE oral solution, for oral use CII Initial U.S. Approval: 1947 17856-3556-5 2023-11-02 These highlights do not include all the information needed to use METHADONE HYDROCHLORIDE ORAL SOLUTION safely and effectively. See full prescribing information for METHADONE HYDROCHLORIDE ORAL SOLUTION. METHADONE HYDROCHLORIDE oral solution, for oral use CII Initial U.S. Approval: 1947 17856-3556-6 2023-11-02 These highlights do not include all the information needed to use METHADONE HYDROCHLORIDE ORAL SOLUTION safely and effectively. See full prescribing information for METHADONE HYDROCHLORIDE ORAL SOLUTION. METHADONE HYDROCHLORIDE oral solution, for oral use CII Initial U.S. Approval: 1947 17856-3556-5 2022-01-28 These highlights do not include all the information needed to use METHADONE HYDROCHLORIDE ORAL SOLUTION safely and effectively. See full prescribing information for METHADONE HYDROCHLORIDE ORAL SOLUTION. METHADONE HYDROCHLORIDE oral solution, for oral use CII Initial U.S. Approval: 1947 17856-3556-6 2022-01-28 These highlights do not include all the information needed to use METHADONE HYDROCHLORIDE ORAL SOLUTION safely and effectively. See full prescribing information for METHADONE HYDROCHLORIDE ORAL SOLUTION. METHADONE HYDROCHLORIDE oral solution, for oral use CII Initial U.S. Approval: 1947 17856-3556-5 2020-04-28 These highlights do not include all the information needed to use METHADONE HYDROCHLORIDE ORAL SOLUTION safely and effectively. See full prescribing information for METHADONE HYDROCHLORIDE ORAL SOLUTION. METHADONE HYDROCHLORIDE oral solution, for oral use CII Initial U.S. Approval: 1947 17856-3556-6 2020-04-28 These highlights do not include all the information needed to use METHADONE HYDROCHLORIDE ORAL SOLUTION safely and effectively. See full prescribing information for METHADONE HYDROCHLORIDE ORAL SOLUTION. METHADONE HYDROCHLORIDE oral solution, for oral use CII Initial U.S. Approval: 1947 17856-3556-5 2020-01-31 These highlights do not include all the information needed to use METHADONE HYDROCHLORIDE ORAL SOLUTION safely and effectively. See full prescribing information for METHADONE HYDROCHLORIDE ORAL SOLUTION. METHADONE HYDROCHLORIDE oral solution, for oral use CII Initial U.S. Approval: 1947 17856-3556-6 2020-01-31 These highlights do not include all the information needed to use METHADONE HYDROCHLORIDE ORAL SOLUTION safely and effectively. See full prescribing information for METHADONE HYDROCHLORIDE ORAL SOLUTION. METHADONE HYDROCHLORIDE oral solution, for oral use CII Initial U.S. Approval: 1947
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 17856-3556-5 Methadone Hydrochloride 10 mL in 1 CUP SOLUTION 10 15 17856-3556-5 Methadone Hydrochloride 72 in 1 CASE SOLUTION 72 15 17856-3556-6 Methadone Hydrochloride 5 mL in 1 CUP, UNIT-DOSE SOLUTION 5 15 17856-3556-6 Methadone Hydrochloride 72 in 1 CASE SOLUTION 72 15
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 17856-3556 METHADONE HYDROCHLORIDE SOLUTION [ATLANTIC BIOLOGICALS CORP.] 15 Legacy NDC, 4 package rows 20231103_c3c1b3f7-3bb1-4864-b634-8fc9dbaac9bb.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 17856-3556-5 17856355605 72 CUP in 1 CASE (17856-3556-5) > 10 mL in 1 CUP 72 cup 2020-04-27 0000-00-00 No No Current 17856-3556-6 17856355606 72 CUP, UNIT-DOSE in 1 CASE (17856-3556-6) > 5 mL in 1 CUP, UNIT-DOSE 2020-04-27 0000-00-00 No No Current