Home NDC 0054-0940 TAPENTADOL
Product NDC 0054-0940
11-digit product format 000540940
Labeler code 0054
Product ID 0054-0940_7fef46e2-c049-44d8-962f-fdd233dad041
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Tapentadol Hydrochloride
Dosage form TABLET, FILM COATED, EXTENDED RELEASE
Route ORAL
Labeler Hikma Pharmaceuticals USA Inc.
Application NDA200533
Marketing category NDA AUTHORIZED GENERIC
Marketing start 2025-12-15
Substance TAPENTADOL HYDROCHLORIDE
Active strength 250 mg/1
Pharmacologic classes Opioid Agonist [EPC], Opioid Agonists [MoA]
DEA schedule CII
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 45 .
Orange Book products# Current product rows page 1 of 1 · 5 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N200533-001 NUCYNTA ER TAPENTADOL HYDROCHLORIDE EQ 50MG BASE TABLET, EXTENDED RELEASE / ORAL RLD 2011-08-25 N200533-002 NUCYNTA ER TAPENTADOL HYDROCHLORIDE EQ 100MG BASE TABLET, EXTENDED RELEASE / ORAL RLD 2011-08-25 N200533-003 NUCYNTA ER TAPENTADOL HYDROCHLORIDE EQ 150MG BASE TABLET, EXTENDED RELEASE / ORAL RLD 2011-08-25 N200533-004 NUCYNTA ER TAPENTADOL HYDROCHLORIDE EQ 200MG BASE TABLET, EXTENDED RELEASE / ORAL RLD 2011-08-25 N200533-005 NUCYNTA ER TAPENTADOL HYDROCHLORIDE EQ 250MG BASE TABLET, EXTENDED RELEASE / ORAL RLD, RS 2011-08-25
Orange Book patents# Current patent rows page 1 of 1 · 25 matching rows.
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 6 · 225 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 2026-11-14 07:37:17 2026-10 N200533-001 NUCYNTA ER EQ 50MG BASE TABLET, EXTENDED RELEASE / ORAL RLD 2011-08-25 d4dbc9d85df4…2026-11-14 07:37:17 2026-10 N200533-002 NUCYNTA ER EQ 100MG BASE TABLET, EXTENDED RELEASE / ORAL RLD 2011-08-25 d4dbc9d85df4…2026-11-14 07:37:17 2026-10 N200533-003 NUCYNTA ER EQ 150MG BASE TABLET, EXTENDED RELEASE / ORAL RLD 2011-08-25 d4dbc9d85df4…2026-11-14 07:37:17 2026-10 N200533-004 NUCYNTA ER EQ 200MG BASE TABLET, EXTENDED RELEASE / ORAL RLD 2011-08-25 d4dbc9d85df4…2026-11-14 07:37:17 2026-10 N200533-005 NUCYNTA ER EQ 250MG BASE TABLET, EXTENDED RELEASE / ORAL RLD, RS 2011-08-25 d4dbc9d85df4…2026-10-15 13:18:30 2026-09 N200533-001 NUCYNTA ER EQ 50MG BASE TABLET, EXTENDED RELEASE / ORAL RLD 2011-08-25 c2088c7a36db…2026-10-15 13:18:30 2026-09 N200533-002 NUCYNTA ER EQ 100MG BASE TABLET, EXTENDED RELEASE / ORAL RLD 2011-08-25 c2088c7a36db…2026-10-15 13:18:30 2026-09 N200533-003 NUCYNTA ER EQ 150MG BASE TABLET, EXTENDED RELEASE / ORAL RLD 2011-08-25 c2088c7a36db…2026-10-15 13:18:30 2026-09 N200533-004 NUCYNTA ER EQ 200MG BASE TABLET, EXTENDED RELEASE / ORAL RLD 2011-08-25 c2088c7a36db…2026-10-15 13:18:30 2026-09 N200533-005 NUCYNTA ER EQ 250MG BASE TABLET, EXTENDED RELEASE / ORAL RLD, RS 2011-08-25 c2088c7a36db…2026-09-14 22:38:34 2026-08 N200533-001 NUCYNTA ER EQ 50MG BASE TABLET, EXTENDED RELEASE / ORAL RLD 2011-08-25 84e616aacf4f…2026-09-14 22:38:34 2026-08 N200533-002 NUCYNTA ER EQ 100MG BASE TABLET, EXTENDED RELEASE / ORAL RLD 2011-08-25 84e616aacf4f…2026-09-14 22:38:34 2026-08 N200533-003 NUCYNTA ER EQ 150MG BASE TABLET, EXTENDED RELEASE / ORAL RLD 2011-08-25 84e616aacf4f…2026-09-14 22:38:34 2026-08 N200533-004 NUCYNTA ER EQ 200MG BASE TABLET, EXTENDED RELEASE / ORAL RLD 2011-08-25 84e616aacf4f…2026-09-14 22:38:34 2026-08 N200533-005 NUCYNTA ER EQ 250MG BASE TABLET, EXTENDED RELEASE / ORAL RLD, RS 2011-08-25 84e616aacf4f…2026-08-18 06:07:40 2026-07 N200533-001 NUCYNTA ER EQ 50MG BASE TABLET, EXTENDED RELEASE / ORAL RLD 2011-08-25 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N200533-002 NUCYNTA ER EQ 100MG BASE TABLET, EXTENDED RELEASE / ORAL RLD 2011-08-25 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N200533-003 NUCYNTA ER EQ 150MG BASE TABLET, EXTENDED RELEASE / ORAL RLD 2011-08-25 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N200533-004 NUCYNTA ER EQ 200MG BASE TABLET, EXTENDED RELEASE / ORAL RLD 2011-08-25 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N200533-005 NUCYNTA ER EQ 250MG BASE TABLET, EXTENDED RELEASE / ORAL RLD, RS 2011-08-25 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N200533-001 NUCYNTA ER EQ 50MG BASE TABLET, EXTENDED RELEASE / ORAL RLD 2011-08-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N200533-002 NUCYNTA ER EQ 100MG BASE TABLET, EXTENDED RELEASE / ORAL RLD 2011-08-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N200533-003 NUCYNTA ER EQ 150MG BASE TABLET, EXTENDED RELEASE / ORAL RLD 2011-08-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N200533-004 NUCYNTA ER EQ 200MG BASE TABLET, EXTENDED RELEASE / ORAL RLD 2011-08-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N200533-005 NUCYNTA ER EQ 250MG BASE TABLET, EXTENDED RELEASE / ORAL RLD, RS 2011-08-25 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N200533-001 NUCYNTA ER EQ 50MG BASE TABLET, EXTENDED RELEASE / ORAL RLD 2011-08-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N200533-002 NUCYNTA ER EQ 100MG BASE TABLET, EXTENDED RELEASE / ORAL RLD 2011-08-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N200533-003 NUCYNTA ER EQ 150MG BASE TABLET, EXTENDED RELEASE / ORAL RLD 2011-08-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N200533-004 NUCYNTA ER EQ 200MG BASE TABLET, EXTENDED RELEASE / ORAL RLD 2011-08-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N200533-005 NUCYNTA ER EQ 250MG BASE TABLET, EXTENDED RELEASE / ORAL RLD, RS 2011-08-25 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N200533-001 NUCYNTA ER EQ 50MG BASE TABLET, EXTENDED RELEASE / ORAL RLD 2011-08-25 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N200533-002 NUCYNTA ER EQ 100MG BASE TABLET, EXTENDED RELEASE / ORAL RLD 2011-08-25 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N200533-003 NUCYNTA ER EQ 150MG BASE TABLET, EXTENDED RELEASE / ORAL RLD 2011-08-25 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N200533-004 NUCYNTA ER EQ 200MG BASE TABLET, EXTENDED RELEASE / ORAL RLD 2011-08-25 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N200533-005 NUCYNTA ER EQ 250MG BASE TABLET, EXTENDED RELEASE / ORAL RLD, RS 2011-08-25 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N200533-001 NUCYNTA ER EQ 50MG BASE TABLET, EXTENDED RELEASE / ORAL RLD 2011-08-25 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N200533-002 NUCYNTA ER EQ 100MG BASE TABLET, EXTENDED RELEASE / ORAL RLD 2011-08-25 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N200533-003 NUCYNTA ER EQ 150MG BASE TABLET, EXTENDED RELEASE / ORAL RLD 2011-08-25 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N200533-004 NUCYNTA ER EQ 200MG BASE TABLET, EXTENDED RELEASE / ORAL RLD 2011-08-25 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N200533-005 NUCYNTA ER EQ 250MG BASE TABLET, EXTENDED RELEASE / ORAL RLD, RS 2011-08-25 fd3edfee7708…
Observed Orange Book patent history# Patent history page 1 of 52 · 2,080 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base TAPENTADOL
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength TAPENTADOL HYDROCHLORIDE 250 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 71204KII53 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 5 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1148797 Internal RxNorm lookup 1148800 Internal RxNorm lookup 1148803 Internal RxNorm lookup 1148807 Internal RxNorm lookup 1148809 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0054-0940-21 TAPENTADOL 60 in 1 BOTTLE, PLASTIC TABLET, FILM COATED, EXTENDED RE 60 3
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 · 2 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 0054-0940-21 00054094021 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0054-0940-21) 2025-12-15 No No Current