Home NDC 50458-650 ULTRACET
Product NDC 50458-650
11-digit product format 504580650
Labeler code 50458
Product ID 50458-650_a2b86fcc-0371-11ed-8fc7-fdbb42d6beab
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name tramadol hydrochloride and acetaminophen
Dosage form TABLET, COATED
Route ORAL
Labeler Janssen Pharmaceuticals, Inc.
Application NDA021123
Marketing category NDA
Marketing start 2001-08-15
Marketing end 0000-00-00
Substance ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE
Active strength 325 mg/1; mg/1
Pharmacologic classes Full Opioid Agonists [MoA], Opioid Agonist [EPC]
DEA schedule CIV
NDC exclude flag No
Listing certified through 2023-12-31
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.
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 N021123-001 ULTRACET ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE 325MG;37.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2001-08-15
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UTC 2026-02 N021123-001 ULTRACET 325MG;37.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2001-08-15 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021123-001 ULTRACET 325MG;37.5MG TABLET / ORAL RLD 2001-08-15 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N021123-001 ULTRACET 325MG;37.5MG TABLET / ORAL RLD 2001-08-15 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021123-001 ULTRACET 325MG;37.5MG TABLET / ORAL RLD 2001-08-15 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021123-001 ULTRACET 325MG;37.5MG TABLET / ORAL RLD 2001-08-15 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021123-001 ULTRACET 325MG;37.5MG TABLET / ORAL RLD 2001-08-15 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021123-001 ULTRACET 325MG;37.5MG TABLET / ORAL RLD 2001-08-15 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021123-001 ULTRACET 325MG;37.5MG TABLET / ORAL RLD 2001-08-15 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021123-001 ULTRACET 325MG;37.5MG TABLET / ORAL RLD 2001-08-15 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N021123-001 ULTRACET 325MG;37.5MG TABLET / ORAL RLD 2001-08-15 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021123-001 ULTRACET 325MG;37.5MG TABLET / ORAL RLD 2001-08-15 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021123-001 ULTRACET 325MG;37.5MG TABLET / ORAL RLD 2001-08-15 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021123-001 ULTRACET 325MG;37.5MG TABLET / ORAL RLD 2001-08-15 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N021123-001 ULTRACET 325MG;37.5MG TABLET / ORAL RLD 2001-08-15 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021123-001 ULTRACET 325MG;37.5MG TABLET / ORAL AB RLD, RS 2001-08-15 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N021123-001 ULTRACET 325MG;37.5MG TABLET / ORAL AB RLD, RS 2001-08-15 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N021123-001 ULTRACET 325MG;37.5MG TABLET / ORAL AB RLD, RS 2001-08-15 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N021123-001 ULTRACET 325MG;37.5MG TABLET / ORAL AB RLD, RS 2001-08-15 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N021123-001 ULTRACET 325MG;37.5MG TABLET / ORAL AB RLD, RS 2001-08-15 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N021123-001 ULTRACET 325MG;37.5MG TABLET / ORAL AB RLD, RS 2001-08-15 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N021123-001 ULTRACET 325MG;37.5MG TABLET / ORAL AB RLD, RS 2001-08-15 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N021123-001 ULTRACET 325MG;37.5MG TABLET / ORAL AB RLD, RS 2001-08-15 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N021123-001 ULTRACET 325MG;37.5MG TABLET / ORAL AB RLD, RS 2001-08-15 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N021123-001 ULTRACET 325MG;37.5MG TABLET / ORAL AB RLD, RS 2001-08-15 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N021123-001 ULTRACET 325MG;37.5MG TABLET / ORAL AB RLD, RS 2001-08-15 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N021123-001 ULTRACET 325MG;37.5MG TABLET / ORAL AB RLD, RS 2001-08-15 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N021123-001 ULTRACET 325MG;37.5MG TABLET / ORAL AB RLD, RS 2001-08-15 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N021123-001 ULTRACET 325MG;37.5MG TABLET / ORAL RLD 2001-08-15 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N021123-001 ULTRACET 325MG;37.5MG TABLET / ORAL RLD 2001-08-15 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N021123-001 ULTRACET 325MG;37.5MG TABLET / ORAL RLD 2001-08-15 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N021123-001 ULTRACET 325MG;37.5MG TABLET / ORAL RLD 2001-08-15 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N021123-001 ULTRACET 325MG;37.5MG TABLET / ORAL RLD 2001-08-15 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N021123-001 ULTRACET 325MG;37.5MG TABLET / ORAL RLD 2001-08-15 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N021123-001 ULTRACET 325MG;37.5MG TABLET / ORAL RLD 2001-08-15 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N021123-001 ULTRACET 325MG;37.5MG TABLET / ORAL RLD 2001-08-15 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N021123-001 ULTRACET 325MG;37.5MG TABLET / ORAL AB RLD, RS 2001-08-15 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N021123-001 ULTRACET 325MG;37.5MG TABLET / ORAL AB RLD, RS 2001-08-15 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N021123-001 ULTRACET 325MG;37.5MG TABLET / ORAL AB RLD, RS 2001-08-15 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N021123-001 ULTRACET 325MG;37.5MG TABLET / ORAL AB RLD, RS 2001-08-15 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N021123-001 ULTRACET 325MG;37.5MG TABLET / ORAL AB RLD, RS 2001-08-15 cb3db0bc1861…
Observed Orange Book normalized TE history# DailyMed Product Concepts# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded acetaminophen ACTIVE INGREDIENT 362O9ITL9D ULTRACET (TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN) TABLET, COATED [JANSSEN PHARMACEUTICALS, INC.] 8 tramadol hydrochloride ACTIVE INGREDIENT 9N7R477WCK ULTRACET (TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN) TABLET, COATED [JANSSEN PHARMACEUTICALS, INC.] 8 acetaminophen ACTIVE MOIETY 362O9ITL9D ULTRACET (TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN) TABLET, COATED [JANSSEN PHARMACEUTICALS, INC.] 8 tramadol ACTIVE MOIETY 39J1LGJ30J ULTRACET (TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN) TABLET, COATED [JANSSEN PHARMACEUTICALS, INC.] 8 carnauba wax INACTIVE INGREDIENT R12CBM0EIZ ULTRACET (TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN) TABLET, COATED [JANSSEN PHARMACEUTICALS, INC.] 8 FERROSOFERRIC OXIDE INACTIVE INGREDIENT XM0M87F357 ULTRACET (TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN) TABLET, COATED [JANSSEN PHARMACEUTICALS, INC.] 8 hypromelloses INACTIVE INGREDIENT 3NXW29V3WO ULTRACET (TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN) TABLET, COATED [JANSSEN PHARMACEUTICALS, INC.] 8 magnesium stearate INACTIVE INGREDIENT 70097M6I30 ULTRACET (TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN) TABLET, COATED [JANSSEN PHARMACEUTICALS, INC.] 8 polyethylene glycols INACTIVE INGREDIENT 3WJQ0SDW1A ULTRACET (TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN) TABLET, COATED [JANSSEN PHARMACEUTICALS, INC.] 8 polysorbate 80 INACTIVE INGREDIENT 6OZP39ZG8H ULTRACET (TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN) TABLET, COATED [JANSSEN PHARMACEUTICALS, INC.] 8 powdered cellulose INACTIVE INGREDIENT SMD1X3XO9M ULTRACET (TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN) TABLET, COATED [JANSSEN PHARMACEUTICALS, INC.] 8 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 ULTRACET (TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN) TABLET, COATED [JANSSEN PHARMACEUTICALS, INC.] 8 starch, corn INACTIVE INGREDIENT O8232NY3SJ ULTRACET (TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN) TABLET, COATED [JANSSEN PHARMACEUTICALS, INC.] 8 titanium dioxide INACTIVE INGREDIENT 15FIX9V2JP ULTRACET (TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN) TABLET, COATED [JANSSEN PHARMACEUTICALS, INC.] 8 acetaminophen ACTIVE INGREDIENT 362O9ITL9D ULTRACET (TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN) TABLET, COATED [PHYSICIANS TOTAL CARE, INC.] 1 tramadol hydrochloride ACTIVE INGREDIENT 9N7R477WCK ULTRACET (TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN) TABLET, COATED [PHYSICIANS TOTAL CARE, INC.] 1 acetaminophen ACTIVE MOIETY 362O9ITL9D ULTRACET (TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN) TABLET, COATED [PHYSICIANS TOTAL CARE, INC.] 1 tramadol ACTIVE MOIETY 39J1LGJ30J ULTRACET (TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN) TABLET, COATED [PHYSICIANS TOTAL CARE, INC.] 1 carnauba wax INACTIVE INGREDIENT R12CBM0EIZ ULTRACET (TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN) TABLET, COATED [PHYSICIANS TOTAL CARE, INC.] 1 FERROSOFERRIC OXIDE INACTIVE INGREDIENT XM0M87F357 ULTRACET (TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN) TABLET, COATED [PHYSICIANS TOTAL CARE, INC.] 1 hypromelloses INACTIVE INGREDIENT 3NXW29V3WO ULTRACET (TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN) TABLET, COATED [PHYSICIANS TOTAL CARE, INC.] 1 magnesium stearate INACTIVE INGREDIENT 70097M6I30 ULTRACET (TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN) TABLET, COATED [PHYSICIANS TOTAL CARE, INC.] 1 polyethylene glycols INACTIVE INGREDIENT 3WJQ0SDW1A ULTRACET (TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN) TABLET, COATED [PHYSICIANS TOTAL CARE, INC.] 1 polysorbate 80 INACTIVE INGREDIENT 6OZP39ZG8H ULTRACET (TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN) TABLET, COATED [PHYSICIANS TOTAL CARE, INC.] 1 powdered cellulose INACTIVE INGREDIENT SMD1X3XO9M ULTRACET (TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN) TABLET, COATED [PHYSICIANS TOTAL CARE, INC.] 1 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 ULTRACET (TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN) TABLET, COATED [PHYSICIANS TOTAL CARE, INC.] 1 starch, corn INACTIVE INGREDIENT O8232NY3SJ ULTRACET (TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN) TABLET, COATED [PHYSICIANS TOTAL CARE, INC.] 1 titanium dioxide INACTIVE INGREDIENT 15FIX9V2JP ULTRACET (TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN) TABLET, COATED [PHYSICIANS TOTAL CARE, INC.] 1
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 50458-650-10 50458065010 10 BLISTER PACK in 1 BOX, UNIT-DOSE (50458-650-10) > 10 TABLET, COATED in 1 BLISTER PACK 10 blister pack 2001-08-15 0000-00-00 No No Current 50458-650-60 50458065060 100 TABLET, COATED in 1 BOTTLE (50458-650-60) 2001-08-15 2022-10-26 No No Current