Home NDC 50090-4716 TRAMADOL HYDROCHLORIDE
Product NDC 50090-4716
11-digit product format 500904716
Labeler code 50090
Product ID 50090-4716_d7e910b0-e667-41b2-9b42-8cf67ff3dfc0
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name TRAMADOL HYDROCHLORIDE
Dosage form TABLET, FILM COATED
Route ORAL
Labeler A-S Medication Solutions
Application ANDA091498
Marketing category ANDA
Marketing start 2015-05-22
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 2020-12-31
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 2 · 120 matching rows.
View current auxiliary records. · View the auxiliary file history.
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 A091498-001 TRAMADOL HYDROCHLORIDE TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL AB 2013-03-29
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A091498-001 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 A091498-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL AB 2013-03-29 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A091498-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL AB 2013-03-29 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A091498-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL AB 2013-03-29 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A091498-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL AB 2013-03-29 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A091498-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL AB 2013-03-29 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A091498-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL AB 2013-03-29 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A091498-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL AB 2013-03-29 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A091498-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL AB 2013-03-29 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A091498-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL AB 2013-03-29 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A091498-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL AB 2013-03-29 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A091498-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL AB 2013-03-29 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A091498-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL AB 2013-03-29 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A091498-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL AB 2013-03-29 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A091498-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL AB 2013-03-29 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A091498-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL AB 2013-03-29 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A091498-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL AB 2013-03-29 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A091498-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL AB 2013-03-29 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A091498-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL AB 2013-03-29 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A091498-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL AB 2013-03-29 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A091498-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL AB 2013-03-29 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A091498-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL AB 2013-03-29 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A091498-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL AB 2013-03-29 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A091498-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL AB 2013-03-29 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A091498-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL AB 2013-03-29 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A091498-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL AB 2013-03-29 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A091498-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL AB 2013-03-29 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A091498-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL AB 2013-03-29 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A091498-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL AB 2013-03-29 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A091498-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL AB 2013-03-29 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A091498-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL AB 2013-03-29 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A091498-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL AB 2013-03-29 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A091498-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL AB 2013-03-29 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A091498-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL AB 2013-03-29 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A091498-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL AB 2013-03-29 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A091498-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL AB 2013-03-29 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A091498-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL AB 2013-03-29 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A091498-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL AB 2013-03-29 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A091498-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL AB 2013-03-29 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A091498-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL AB 2013-03-29 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A091498-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL AB 2013-03-29 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, Related label table NDC Related label 50090-4716-0 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, CIV Initial U.S. Approval: 1995 50090-4716-1 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, CIV Initial U.S. Approval: 1995 50090-4716-2 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, CIV Initial U.S. Approval: 1995 50090-4716-3 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, CIV Initial U.S. Approval: 1995 50090-4716-4 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, CIV Initial U.S. Approval: 1995 50090-4716-5 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, CIV Initial U.S. Approval: 1995 50090-4716-9 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, CIV Initial U.S. Approval: 1995
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 50090-4716-0 TRAMADOL HYDROCHLORIDE 30 in 1 BOTTLE TABLET, FILM COATED 30 1 50090-4716-1 TRAMADOL HYDROCHLORIDE 20 in 1 BOTTLE TABLET, FILM COATED 20 1 50090-4716-2 TRAMADOL HYDROCHLORIDE 50 in 1 BOTTLE TABLET, FILM COATED 50 1 50090-4716-3 TRAMADOL HYDROCHLORIDE 100 in 1 BOTTLE TABLET, FILM COATED 100 1 50090-4716-4 TRAMADOL HYDROCHLORIDE 15 in 1 BOTTLE TABLET, FILM COATED 15 1 50090-4716-5 TRAMADOL HYDROCHLORIDE 60 in 1 BOTTLE TABLET, FILM COATED 60 1 50090-4716-9 TRAMADOL HYDROCHLORIDE 120 in 1 BOTTLE TABLET, FILM COATED 120 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50090-4716 TRAMADOL HYDROCHLORIDE TABLET, FILM COATED [A-S MEDICATION SOLUTIONS] 1 Legacy NDC, 7 package rows 20191206_333b1122-b960-4e20-a675-e2c08361defc.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 Marketing start Marketing end Sample Exclude flag Status 50090-4716-0 50090471600 30 TABLET, FILM COATED in 1 BOTTLE (50090-4716-0) 2019-11-13 0000-00-00 No No Current 50090-4716-1 50090471601 20 TABLET, FILM COATED in 1 BOTTLE (50090-4716-1) 2019-11-13 0000-00-00 No No Current 50090-4716-2 50090471602 50 TABLET, FILM COATED in 1 BOTTLE (50090-4716-2) 2019-11-13 0000-00-00 No No Current 50090-4716-3 50090471603 100 TABLET, FILM COATED in 1 BOTTLE (50090-4716-3) 2019-11-13 0000-00-00 No No Current 50090-4716-4 50090471604 15 TABLET, FILM COATED in 1 BOTTLE (50090-4716-4) 2019-11-13 0000-00-00 No No Current 50090-4716-5 50090471605 60 TABLET, FILM COATED in 1 BOTTLE (50090-4716-5) 2019-11-13 0000-00-00 No No Current 50090-4716-9 50090471609 120 TABLET, FILM COATED in 1 BOTTLE (50090-4716-9) 2019-11-13 0000-00-00 No No Current