Home NDC 50458-659 ULTRAM
Product NDC 50458-659
11-digit product format 504580659
Labeler code 50458
Product ID 50458-659_573482f4-b6a3-11ec-b822-b84b65fc2800
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name tramadol hydrochloride
Dosage form TABLET, COATED
Route ORAL
Labeler Janssen Pharmaceuticals, Inc.
Application NDA020281
Marketing category NDA
Marketing start 1995-03-03
Marketing end 2040-09-30
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 0000-00-00
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 · 24 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 50458-659-60 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 50458-659-60 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 50458-659-60 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 50458-659-60 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 50458-659-60 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 50458-659-60 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 50458-659-60 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 50458-659-60 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 50458-659-60 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 50458-659-60 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 50458-659-60 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 50458-659-60 557ba5c1ecfa…9c80585c8c6e…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N020281-001 ULTRAM TRAMADOL HYDROCHLORIDE 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1995-03-03 N020281-002 ULTRAM TRAMADOL HYDROCHLORIDE 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1995-03-03
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 3 · 82 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 N020281-001 ULTRAM 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1995-03-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N020281-002 ULTRAM 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1995-03-03 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020281-001 ULTRAM 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1995-03-03 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020281-002 ULTRAM 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1995-03-03 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N020281-001 ULTRAM 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1995-03-03 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N020281-002 ULTRAM 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1995-03-03 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020281-001 ULTRAM 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1995-03-03 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020281-002 ULTRAM 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1995-03-03 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020281-001 ULTRAM 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1995-03-03 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020281-002 ULTRAM 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1995-03-03 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020281-001 ULTRAM 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1995-03-03 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020281-002 ULTRAM 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1995-03-03 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020281-001 ULTRAM 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1995-03-03 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020281-002 ULTRAM 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1995-03-03 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020281-001 ULTRAM 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1995-03-03 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020281-002 ULTRAM 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1995-03-03 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020281-001 ULTRAM 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1995-03-03 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020281-002 ULTRAM 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1995-03-03 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N020281-001 ULTRAM 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1995-03-03 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N020281-002 ULTRAM 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1995-03-03 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020281-001 ULTRAM 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1995-03-03 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020281-002 ULTRAM 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1995-03-03 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N020281-001 ULTRAM 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1995-03-03 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N020281-002 ULTRAM 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1995-03-03 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N020281-001 ULTRAM 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1995-03-03 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N020281-002 ULTRAM 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1995-03-03 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N020281-001 ULTRAM 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1995-03-03 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N020281-002 ULTRAM 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1995-03-03 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N020281-001 ULTRAM 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL 1995-03-03 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N020281-002 ULTRAM 50MG TABLET / ORAL AB RLD, RS 1995-03-03 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N020281-001 ULTRAM 100MG TABLET / ORAL 1995-03-03 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N020281-002 ULTRAM 50MG TABLET / ORAL AB RLD, RS 1995-03-03 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N020281-001 ULTRAM 100MG TABLET / ORAL 1995-03-03 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N020281-002 ULTRAM 50MG TABLET / ORAL AB RLD, RS 1995-03-03 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N020281-001 ULTRAM 100MG TABLET / ORAL 1995-03-03 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N020281-002 ULTRAM 50MG TABLET / ORAL AB RLD, RS 1995-03-03 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N020281-001 ULTRAM 100MG TABLET / ORAL 1995-03-03 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N020281-002 ULTRAM 50MG TABLET / ORAL AB RLD, RS 1995-03-03 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N020281-001 ULTRAM 100MG TABLET / ORAL 1995-03-03 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N020281-002 ULTRAM 50MG TABLET / ORAL AB RLD, RS 1995-03-03 782e0a99824c…
Observed Orange Book normalized TE history# Observed Orange Book patent history# Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2019-12-13 00:20 UTC 2019-12 N020281-001 6339105 2019-10-12 U-435 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N020281-001 6339105*PED 2020-04-12 Pediatric extension 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N020281-002 6339105 2019-10-12 U-435 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N020281-002 6339105*PED 2020-04-12 Pediatric extension 74a2ff9319b5…2020-12-22 03:56 UTC 2020-12 N020281-001 6339105*PED 2020-04-12 Pediatric extension 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 N020281-002 6339105*PED 2020-04-12 Pediatric extension 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N020281-001 6339105*PED 2020-04-12 Pediatric extension c0c555d07b60…2020-11-12 02:37 UTC 2020-11 N020281-002 6339105*PED 2020-04-12 Pediatric extension c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N020281-001 6339105 2019-10-12 U-435 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N020281-001 6339105*PED 2020-04-12 Pediatric extension 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N020281-002 6339105 2019-10-12 U-435 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N020281-002 6339105*PED 2020-04-12 Pediatric extension 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N020281-001 6339105 2019-10-12 U-435 b00525d2431f…2019-09-15 20:21 UTC 2019-09 N020281-001 6339105*PED 2020-04-12 Pediatric extension b00525d2431f…2019-09-15 20:21 UTC 2019-09 N020281-002 6339105 2019-10-12 U-435 b00525d2431f…2019-09-15 20:21 UTC 2019-09 N020281-002 6339105*PED 2020-04-12 Pediatric extension b00525d2431f…2019-07-19 19:46 UTC 2019-07 N020281-001 6339105 2019-10-12 U-435 ea99ee380514…2019-07-19 19:46 UTC 2019-07 N020281-001 6339105*PED 2020-04-12 Pediatric extension ea99ee380514…2019-07-19 19:46 UTC 2019-07 N020281-002 6339105 2019-10-12 U-435 ea99ee380514…2019-07-19 19:46 UTC 2019-07 N020281-002 6339105*PED 2020-04-12 Pediatric extension ea99ee380514…
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded tramadol hydrochloride ACTIVE INGREDIENT 9N7R477WCK ULTRAM (TRAMADOL HYDROCHLORIDE) TABLET, COATED [JANSSEN PHARMACEUTICALS, INC.] 6 tramadol ACTIVE MOIETY 39J1LGJ30J ULTRAM (TRAMADOL HYDROCHLORIDE) TABLET, COATED [JANSSEN PHARMACEUTICALS, INC.] 6 carnauba wax INACTIVE INGREDIENT R12CBM0EIZ ULTRAM (TRAMADOL HYDROCHLORIDE) TABLET, COATED [JANSSEN PHARMACEUTICALS, INC.] 6 cellulose, microcrystalline INACTIVE INGREDIENT OP1R32D61U ULTRAM (TRAMADOL HYDROCHLORIDE) TABLET, COATED [JANSSEN PHARMACEUTICALS, INC.] 6 hypromelloses INACTIVE INGREDIENT 3NXW29V3WO ULTRAM (TRAMADOL HYDROCHLORIDE) TABLET, COATED [JANSSEN PHARMACEUTICALS, INC.] 6 lactose INACTIVE INGREDIENT J2B2A4N98G ULTRAM (TRAMADOL HYDROCHLORIDE) TABLET, COATED [JANSSEN PHARMACEUTICALS, INC.] 6 magnesium stearate INACTIVE INGREDIENT 70097M6I30 ULTRAM (TRAMADOL HYDROCHLORIDE) TABLET, COATED [JANSSEN PHARMACEUTICALS, INC.] 6 modified corn starch (1-octenyl succinic anhydride) INACTIVE INGREDIENT 461P5CJN6T ULTRAM (TRAMADOL HYDROCHLORIDE) TABLET, COATED [JANSSEN PHARMACEUTICALS, INC.] 6 polyethylene glycols INACTIVE INGREDIENT 3WJQ0SDW1A ULTRAM (TRAMADOL HYDROCHLORIDE) TABLET, COATED [JANSSEN PHARMACEUTICALS, INC.] 6 polysorbate 80 INACTIVE INGREDIENT 6OZP39ZG8H ULTRAM (TRAMADOL HYDROCHLORIDE) TABLET, COATED [JANSSEN PHARMACEUTICALS, INC.] 6 sodium starch glycolate type a potato INACTIVE INGREDIENT 5856J3G2A2 ULTRAM (TRAMADOL HYDROCHLORIDE) TABLET, COATED [JANSSEN PHARMACEUTICALS, INC.] 6 starch, corn INACTIVE INGREDIENT O8232NY3SJ ULTRAM (TRAMADOL HYDROCHLORIDE) TABLET, COATED [JANSSEN PHARMACEUTICALS, INC.] 6 titanium dioxide INACTIVE INGREDIENT 15FIX9V2JP ULTRAM (TRAMADOL HYDROCHLORIDE) TABLET, COATED [JANSSEN PHARMACEUTICALS, INC.] 6
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 50458-659-60 50458065960 100 TABLET, COATED in 1 BOTTLE (50458-659-60) 1995-03-03 0000-00-00 No No Current