Home NDC 55700-606 Nucynta
Product NDC 55700-606
11-digit product format 557000606
Labeler code 55700
Product ID 55700-606_b09da754-192b-4390-892c-1946dedf704a
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name tapentadol hydrochloride
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Lake Erie Medical DBA Quality Care Products LLC
Application NDA022304
Marketing category NDA
Marketing start 2018-04-20
Marketing end 0000-00-00
Substance TAPENTADOL HYDROCHLORIDE
Active strength 50 mg/1
Pharmacologic classes Opioid Agonist [EPC],Opioid Agonists [MoA]
DEA schedule CII
NDC exclude flag No
Listing certified through 2020-12-31
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 · 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 55700-606-30 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 55700-606-30 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 55700-606-30 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 55700-606-30 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 55700-606-30 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 55700-606-30 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 55700-606-30 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 55700-606-30 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 55700-606-30 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 55700-606-30 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 55700-606-30 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 55700-606-30 557ba5c1ecfa…9c80585c8c6e…
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.
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.