Home Applications 021123 Application 021123
Type NDA
Sponsor JANSSEN PHARMS Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 ULTRACET ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE TABLET;ORAL 325MG;37.5MG Yes Yes
Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
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TRAMADOL HYDROCHLORIDE 325MG;37.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2001-08-15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 2 of 2 · 44 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 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…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N021123-001 ULTRACET 325MG;37.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2001-08-15 a50c72e98297…
Observed Orange Book normalized TE history# Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 9 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 21695-143 ULTRACET tramadol hydrochloride and acetaminophen Rebel Distributors Corp NDA Current 50458-650 ULTRACET tramadol hydrochloride and acetaminophen Janssen Pharmaceuticals, Inc. NDA Current 50458-650 ULTRACET tramadol hydrochloride and acetaminophen Janssen Pharmaceuticals, Inc. NDA Current 50458-650 ULTRACET tramadol hydrochloride and acetaminophen Janssen Pharmaceuticals, Inc. NDA Current 50458-650 ULTRACET tramadol hydrochloride and acetaminophen Janssen Pharmaceuticals, Inc. NDA Current 50458-650 ULTRACET tramadol hydrochloride and acetaminophen Janssen Pharmaceuticals, Inc. NDA Current 50458-650 ULTRACET tramadol hydrochloride and acetaminophen Janssen Pharmaceuticals, Inc. NDA Current 50458-650 ULTRACET tramadol hydrochloride and acetaminophen Janssen Pharmaceuticals, Inc. NDA Current 50458-650 ULTRACET tramadol hydrochloride and acetaminophen Janssen Pharmaceuticals, Inc. NDA Current