Home NDC 0054-0945 TAPENTADOL
Product NDC 0054-0945
11-digit product format 000540945
Labeler code 0054
Product ID 0054-0945_7f43eb28-160b-4256-bde1-ed711407ad01
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Tapentadol Hydrochloride
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Hikma Pharmaceuticals USA Inc.
Application NDA022304
Marketing category NDA AUTHORIZED GENERIC
Marketing start 2025-12-15
Substance TAPENTADOL HYDROCHLORIDE
Active strength 100 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 1 .
Orange Book products# Current product rows page 1 of 1 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N022304-001 NUCYNTA TAPENTADOL HYDROCHLORIDE EQ 50MG BASE TABLET / ORAL AB RLD 2008-11-20 N022304-002 NUCYNTA TAPENTADOL HYDROCHLORIDE EQ 75MG BASE TABLET / ORAL AB RLD 2008-11-20 N022304-003 NUCYNTA TAPENTADOL HYDROCHLORIDE EQ 100MG BASE TABLET / ORAL AB RLD, RS 2008-11-20
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 matching rows.
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 6 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 4 · 123 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 N022304-001 NUCYNTA EQ 50MG BASE TABLET / ORAL AB RLD 2008-11-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022304-002 NUCYNTA EQ 75MG BASE TABLET / ORAL AB RLD 2008-11-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022304-003 NUCYNTA EQ 100MG BASE TABLET / ORAL AB RLD, RS 2008-11-20 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022304-001 NUCYNTA EQ 50MG BASE TABLET / ORAL RLD 2008-11-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022304-002 NUCYNTA EQ 75MG BASE TABLET / ORAL RLD 2008-11-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022304-003 NUCYNTA EQ 100MG BASE TABLET / ORAL RLD, RS 2008-11-20 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N022304-001 NUCYNTA EQ 50MG BASE TABLET / ORAL RLD 2008-11-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022304-002 NUCYNTA EQ 75MG BASE TABLET / ORAL RLD 2008-11-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022304-003 NUCYNTA EQ 100MG BASE TABLET / ORAL RLD, RS 2008-11-20 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022304-001 NUCYNTA EQ 50MG BASE TABLET / ORAL RLD 2008-11-20 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022304-002 NUCYNTA EQ 75MG BASE TABLET / ORAL RLD 2008-11-20 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022304-003 NUCYNTA EQ 100MG BASE TABLET / ORAL RLD, RS 2008-11-20 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022304-001 NUCYNTA EQ 50MG BASE TABLET / ORAL RLD 2008-11-20 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022304-002 NUCYNTA EQ 75MG BASE TABLET / ORAL RLD 2008-11-20 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022304-003 NUCYNTA EQ 100MG BASE TABLET / ORAL RLD, RS 2008-11-20 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022304-001 NUCYNTA EQ 50MG BASE TABLET / ORAL RLD 2008-11-20 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022304-002 NUCYNTA EQ 75MG BASE TABLET / ORAL RLD 2008-11-20 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022304-003 NUCYNTA EQ 100MG BASE TABLET / ORAL RLD, RS 2008-11-20 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022304-001 NUCYNTA EQ 50MG BASE TABLET / ORAL RLD 2008-11-20 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022304-002 NUCYNTA EQ 75MG BASE TABLET / ORAL RLD 2008-11-20 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022304-003 NUCYNTA EQ 100MG BASE TABLET / ORAL RLD, RS 2008-11-20 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022304-001 NUCYNTA EQ 50MG BASE TABLET / ORAL RLD 2008-11-20 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022304-002 NUCYNTA EQ 75MG BASE TABLET / ORAL RLD 2008-11-20 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022304-003 NUCYNTA EQ 100MG BASE TABLET / ORAL RLD, RS 2008-11-20 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022304-001 NUCYNTA EQ 50MG BASE TABLET / ORAL RLD 2008-11-20 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022304-002 NUCYNTA EQ 75MG BASE TABLET / ORAL RLD 2008-11-20 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022304-003 NUCYNTA EQ 100MG BASE TABLET / ORAL RLD, RS 2008-11-20 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N022304-001 NUCYNTA EQ 50MG BASE TABLET / ORAL RLD 2008-11-20 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N022304-002 NUCYNTA EQ 75MG BASE TABLET / ORAL RLD 2008-11-20 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N022304-003 NUCYNTA EQ 100MG BASE TABLET / ORAL RLD, RS 2008-11-20 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N022304-001 NUCYNTA EQ 50MG BASE TABLET / ORAL RLD 2008-11-20 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N022304-002 NUCYNTA EQ 75MG BASE TABLET / ORAL RLD 2008-11-20 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N022304-003 NUCYNTA EQ 100MG BASE TABLET / ORAL RLD, RS 2008-11-20 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N022304-001 NUCYNTA EQ 50MG BASE TABLET / ORAL RLD 2008-11-20 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N022304-002 NUCYNTA EQ 75MG BASE TABLET / ORAL RLD 2008-11-20 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N022304-003 NUCYNTA EQ 100MG BASE TABLET / ORAL RLD, RS 2008-11-20 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N022304-001 NUCYNTA EQ 50MG BASE TABLET / ORAL RLD 2008-11-20 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N022304-002 NUCYNTA EQ 75MG BASE TABLET / ORAL RLD 2008-11-20 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N022304-003 NUCYNTA EQ 100MG BASE TABLET / ORAL RLD, RS 2008-11-20 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N022304-001 NUCYNTA EQ 50MG BASE TABLET / ORAL RLD 2008-11-20 8072bd15b7f6…
Observed Orange Book normalized TE history# Observed Orange Book patent history# Patent history page 1 of 6 · 201 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022304-001 7994364 2025-06-27 U-931 Drug substance, Drug product 2011-09-02 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022304-001 7994364*PED 2025-12-27 Pediatric extension 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022304-002 7994364 2025-06-27 U-931 Drug substance, Drug product 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022304-002 7994364*PED 2025-12-27 Pediatric extension 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022304-003 7994364 2025-06-27 U-931 Drug substance, Drug product 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022304-003 7994364*PED 2025-12-27 Pediatric extension 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N022304-001 7994364 2025-06-27 U-931 Drug substance, Drug product 2011-09-02 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022304-001 7994364*PED 2025-12-27 Pediatric extension 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022304-002 7994364 2025-06-27 U-931 Drug substance, Drug product 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022304-002 7994364*PED 2025-12-27 Pediatric extension 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022304-003 7994364 2025-06-27 U-931 Drug substance, Drug product 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022304-003 7994364*PED 2025-12-27 Pediatric extension 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022304-001 7994364 2025-06-27 U-931 Drug substance, Drug product 2011-09-02 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022304-001 7994364*PED 2025-12-27 Pediatric extension fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022304-002 7994364 2025-06-27 U-931 Drug substance, Drug product fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022304-002 7994364*PED 2025-12-27 Pediatric extension fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022304-003 7994364 2025-06-27 U-931 Drug substance, Drug product fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022304-003 7994364*PED 2025-12-27 Pediatric extension fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022304-001 7994364 2025-06-27 U-931 Drug substance, Drug product 2011-09-02 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022304-001 7994364*PED 2025-12-27 Pediatric extension b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022304-002 7994364 2025-06-27 U-931 Drug substance, Drug product b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022304-002 7994364*PED 2025-12-27 Pediatric extension b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022304-003 7994364 2025-06-27 U-931 Drug substance, Drug product b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022304-003 7994364*PED 2025-12-27 Pediatric extension b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022304-001 7994364 2025-06-27 U-931 Drug substance, Drug product 2011-09-02 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022304-001 7994364*PED 2025-12-27 Pediatric extension 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022304-002 7994364 2025-06-27 U-931 Drug substance, Drug product 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022304-002 7994364*PED 2025-12-27 Pediatric extension 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022304-003 7994364 2025-06-27 U-931 Drug substance, Drug product 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022304-003 7994364*PED 2025-12-27 Pediatric extension 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022304-001 7994364 2025-06-27 U-931 Drug substance, Drug product 2011-09-02 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022304-001 7994364*PED 2025-12-27 Pediatric extension 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022304-002 7994364 2025-06-27 U-931 Drug substance, Drug product 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022304-002 7994364*PED 2025-12-27 Pediatric extension 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022304-003 7994364 2025-06-27 U-931 Drug substance, Drug product 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022304-003 7994364*PED 2025-12-27 Pediatric extension 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022304-001 7994364 2025-06-27 U-931 Drug substance, Drug product 2011-09-02 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022304-001 7994364*PED 2025-12-27 Pediatric extension 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022304-002 7994364 2025-06-27 U-931 Drug substance, Drug product 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022304-002 7994364*PED 2025-12-27 Pediatric extension 5bbf6a4d5a75…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 3 · 96 observed states.
Additional Listing Data#
Finished product Yes
Brand name base TAPENTADOL
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength TAPENTADOL HYDROCHLORIDE 100 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 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 825409 Internal RxNorm lookup 825411 Internal RxNorm lookup 825413 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 0054-0945-25 TAPENTADOL 100 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 100 2
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 0054-0945-25 00054094525 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0054-0945-25) 2025-12-15 No No Current