Home NDC 50090-0807-2 tramadol hydrochloride
Product NDC 50090-0807
Requested package NDC 50090-0807-2
11-digit product format 500900807
Labeler code 50090
Product ID 50090-0807_30cb0292-f2cb-467d-b14e-0058d863c0f0
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name tramadol hydrochloride
Dosage form TABLET
Route ORAL
Labeler A-S Medication Solutions
Application ANDA075964
Marketing category ANDA
Marketing start 2002-06-22
Marketing end 0000-00-00
Substance TRAMADOL HYDROCHLORIDE
Active strength 50 mg/1
Pharmacologic classes Full Opioid Agonists [MoA],Opioid Agonist [EPC]
DEA schedule CIV
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 2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 50090-0807 50090-0807-2 D Discontinued by firm excluded / ndc_excluded.zip d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 50090-0807 50090-0807-2 D Discontinued by firm excluded / ndc_excluded.zip f5e01cc5f278…a2eaf40c39c3…
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 A075964-001 TRAMADOL HYDROCHLORIDE TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL AB 2002-06-19
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A075964-001 AB
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 A075964-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL AB 2002-06-19 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075964-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL AB 2002-06-19 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A075964-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL AB 2002-06-19 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075964-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL AB 2002-06-19 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075964-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL AB 2002-06-19 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075964-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL AB 2002-06-19 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075964-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL AB 2002-06-19 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075964-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL AB RS 2002-06-19 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075964-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL AB RS 2002-06-19 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A075964-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL AB RS 2002-06-19 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A075964-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL AB RS 2002-06-19 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A075964-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL AB RS 2002-06-19 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A075964-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL AB RS 2002-06-19 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A075964-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL AB RS 2002-06-19 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A075964-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL AB 2002-06-19 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A075964-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL AB 2002-06-19 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A075964-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL AB 2002-06-19 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A075964-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL AB 2002-06-19 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A075964-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL AB 2002-06-19 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A075964-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL AB 2002-06-19 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A075964-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL AB 2002-06-19 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A075964-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL AB 2002-06-19 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A075964-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL AB 2002-06-19 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A075964-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL AB 2002-06-19 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A075964-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL AB 2002-06-19 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A075964-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL AB 2002-06-19 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A075964-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL AB 2002-06-19 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A075964-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL AB RS 2002-06-19 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A075964-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL AB RS 2002-06-19 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A075964-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL AB RS 2002-06-19 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A075964-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL AB RS 2002-06-19 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A075964-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL AB RS 2002-06-19 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A075964-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL AB RS 2002-06-19 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A075964-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL AB RS 2002-06-19 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A075964-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL AB RS 2002-06-19 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A075964-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL AB RS 2002-06-19 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A075964-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL AB RS 2002-06-19 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A075964-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL AB RS 2002-06-19 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A075964-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL AB 2002-06-19 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A075964-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL AB 2002-06-19 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 50090-0807-0 2023-02-07 These highlights do not include all the information needed to use TRAMADOL HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for TRAMADOL HYDROCHLORIDE TABLETS. TRAMADOL HYDROCHLORIDE tablets, for oral use, C-IV Initial U.S. Approval: 1995 50090-0807-1 2023-02-07 These highlights do not include all the information needed to use TRAMADOL HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for TRAMADOL HYDROCHLORIDE TABLETS. TRAMADOL HYDROCHLORIDE tablets, for oral use, C-IV Initial U.S. Approval: 1995 50090-0807-2 2023-02-07 These highlights do not include all the information needed to use TRAMADOL HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for TRAMADOL HYDROCHLORIDE TABLETS. TRAMADOL HYDROCHLORIDE tablets, for oral use, C-IV Initial U.S. Approval: 1995 50090-0807-3 2023-02-07 These highlights do not include all the information needed to use TRAMADOL HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for TRAMADOL HYDROCHLORIDE TABLETS. TRAMADOL HYDROCHLORIDE tablets, for oral use, C-IV Initial U.S. Approval: 1995 50090-0807-4 2023-02-07 These highlights do not include all the information needed to use TRAMADOL HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for TRAMADOL HYDROCHLORIDE TABLETS. TRAMADOL HYDROCHLORIDE tablets, for oral use, C-IV Initial U.S. Approval: 1995 50090-0807-5 2023-02-07 These highlights do not include all the information needed to use TRAMADOL HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for TRAMADOL HYDROCHLORIDE TABLETS. TRAMADOL HYDROCHLORIDE tablets, for oral use, C-IV Initial U.S. Approval: 1995 50090-0807-6 2023-02-07 These highlights do not include all the information needed to use TRAMADOL HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for TRAMADOL HYDROCHLORIDE TABLETS. TRAMADOL HYDROCHLORIDE tablets, for oral use, C-IV Initial U.S. Approval: 1995 50090-0807-0 2023-01-30 These highlights do not include all the information needed to use TRAMADOL HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for TRAMADOL HYDROCHLORIDE TABLETS. TRAMADOL HYDROCHLORIDE tablets, for oral use, C-IV Initial U.S. Approval: 1995 50090-0807-1 2023-01-30 These highlights do not include all the information needed to use TRAMADOL HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for TRAMADOL HYDROCHLORIDE TABLETS. TRAMADOL HYDROCHLORIDE tablets, for oral use, C-IV Initial U.S. Approval: 1995 50090-0807-2 2023-01-30 These highlights do not include all the information needed to use TRAMADOL HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for TRAMADOL HYDROCHLORIDE TABLETS. TRAMADOL HYDROCHLORIDE tablets, for oral use, C-IV Initial U.S. Approval: 1995 50090-0807-3 2023-01-30 These highlights do not include all the information needed to use TRAMADOL HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for TRAMADOL HYDROCHLORIDE TABLETS. TRAMADOL HYDROCHLORIDE tablets, for oral use, C-IV Initial U.S. Approval: 1995 50090-0807-4 2023-01-30 These highlights do not include all the information needed to use TRAMADOL HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for TRAMADOL HYDROCHLORIDE TABLETS. TRAMADOL HYDROCHLORIDE tablets, for oral use, C-IV Initial U.S. Approval: 1995 50090-0807-5 2023-01-30 These highlights do not include all the information needed to use TRAMADOL HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for TRAMADOL HYDROCHLORIDE TABLETS. TRAMADOL HYDROCHLORIDE tablets, for oral use, C-IV Initial U.S. Approval: 1995 50090-0807-6 2023-01-30 These highlights do not include all the information needed to use TRAMADOL HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for TRAMADOL HYDROCHLORIDE TABLETS. TRAMADOL HYDROCHLORIDE tablets, for oral use, C-IV Initial U.S. Approval: 1995
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50090-0807 TRAMADOL HYDROCHLORIDE TABLET [A-S MEDICATION SOLUTIONS] 19 Legacy NDC 20250406_c42fcf3f-9625-469b-b437-486c41d0531b.zip
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 50090-0807-2 50090080702 10 TABLET in 1 BOTTLE (50090-0807-2) 10 tablet 2014-11-28 0000-00-00 No No Current