NUCYNTA

Product NDC
50458-840
11-digit product format
504580840
Labeler code
50458
Product ID
50458-840_926544cc-122c-4f9f-9434-a886827b0871
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
tapentadol hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Janssen Pharmaceuticals, Inc.
Application
NDA022304
Marketing category
NDA
Marketing start
2009-06-01
Marketing end
2020-03-31
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
0000-00-00
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct50458-840DDiscontinued by firm2026-08-11
excluded packagepackage50458-84050458-840-02DDiscontinued by firm2026-08-11
excluded packagepackage50458-84050458-840-04DDiscontinued by firm2026-08-11

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.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage50458-840-02d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage50458-840-04d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage50458-840-02f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage50458-840-04f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage50458-840-022ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage50458-840-042ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage50458-840-02a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage50458-840-04a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage50458-840-02cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage50458-840-04cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage50458-840-02cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage50458-840-04cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage50458-840-02302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage50458-840-04302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage50458-840-02ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage50458-840-04ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage50458-840-020efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage50458-840-040efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage50458-840-02ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage50458-840-04ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage50458-840-02367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage50458-840-04367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage50458-840-02557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage50458-840-04557ba5c1ecfa…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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N022304-001NUCYNTATAPENTADOL HYDROCHLORIDEEQ 50MG BASETABLET / ORALABRLD2008-11-20
N022304-002NUCYNTATAPENTADOL HYDROCHLORIDEEQ 75MG BASETABLET / ORALABRLD2008-11-20
N022304-003NUCYNTATAPENTADOL HYDROCHLORIDEEQ 100MG BASETABLET / ORALABRLD, RS2008-11-20

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
N022304-001AB
N022304-002AB
N022304-003AB

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 6 matching rows.

Application-product, Exclusivity code, Expiration table
Application-productExclusivity codeExpiration
N022304-001NPP2026-07-03
N022304-001PED2027-01-03
N022304-002NPP2026-07-03
N022304-002PED2027-01-03
N022304-003NPP2026-07-03
N022304-003PED2027-01-03

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N022304-001NUCYNTAEQ 50MG BASETABLET / ORALABRLD2008-11-20011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022304-002NUCYNTAEQ 75MG BASETABLET / ORALABRLD2008-11-20011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022304-003NUCYNTAEQ 100MG BASETABLET / ORALABRLD, RS2008-11-20011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022304-001NUCYNTAEQ 50MG BASETABLET / ORALRLD2008-11-2031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022304-002NUCYNTAEQ 75MG BASETABLET / ORALRLD2008-11-2031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022304-003NUCYNTAEQ 100MG BASETABLET / ORALRLD, RS2008-11-2031067a03dcf5…
2025-08-23 18:47 UTC2025-08N022304-001NUCYNTAEQ 50MG BASETABLET / ORALRLD2008-11-206a471c1ec25d…
2025-08-23 18:47 UTC2025-08N022304-002NUCYNTAEQ 75MG BASETABLET / ORALRLD2008-11-206a471c1ec25d…
2025-08-23 18:47 UTC2025-08N022304-003NUCYNTAEQ 100MG BASETABLET / ORALRLD, RS2008-11-206a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022304-001NUCYNTAEQ 50MG BASETABLET / ORALRLD2008-11-20fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022304-002NUCYNTAEQ 75MG BASETABLET / ORALRLD2008-11-20fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022304-003NUCYNTAEQ 100MG BASETABLET / ORALRLD, RS2008-11-20fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N022304-001NUCYNTAEQ 50MG BASETABLET / ORALRLD2008-11-20b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N022304-002NUCYNTAEQ 75MG BASETABLET / ORALRLD2008-11-20b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N022304-003NUCYNTAEQ 100MG BASETABLET / ORALRLD, RS2008-11-20b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N022304-001NUCYNTAEQ 50MG BASETABLET / ORALRLD2008-11-2003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N022304-002NUCYNTAEQ 75MG BASETABLET / ORALRLD2008-11-2003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N022304-003NUCYNTAEQ 100MG BASETABLET / ORALRLD, RS2008-11-2003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N022304-001NUCYNTAEQ 50MG BASETABLET / ORALRLD2008-11-202680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N022304-002NUCYNTAEQ 75MG BASETABLET / ORALRLD2008-11-202680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N022304-003NUCYNTAEQ 100MG BASETABLET / ORALRLD, RS2008-11-202680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N022304-001NUCYNTAEQ 50MG BASETABLET / ORALRLD2008-11-205bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N022304-002NUCYNTAEQ 75MG BASETABLET / ORALRLD2008-11-205bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N022304-003NUCYNTAEQ 100MG BASETABLET / ORALRLD, RS2008-11-205bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N022304-001NUCYNTAEQ 50MG BASETABLET / ORALRLD2008-11-20d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N022304-002NUCYNTAEQ 75MG BASETABLET / ORALRLD2008-11-20d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N022304-003NUCYNTAEQ 100MG BASETABLET / ORALRLD, RS2008-11-20d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N022304-001NUCYNTAEQ 50MG BASETABLET / ORALRLD2008-11-20d06236e962d9…
2024-10-29 15:01 UTC2024-10N022304-002NUCYNTAEQ 75MG BASETABLET / ORALRLD2008-11-20d06236e962d9…
2024-10-29 15:01 UTC2024-10N022304-003NUCYNTAEQ 100MG BASETABLET / ORALRLD, RS2008-11-20d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N022304-001NUCYNTAEQ 50MG BASETABLET / ORALRLD2008-11-2079d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N022304-002NUCYNTAEQ 75MG BASETABLET / ORALRLD2008-11-2079d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N022304-003NUCYNTAEQ 100MG BASETABLET / ORALRLD, RS2008-11-2079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N022304-001NUCYNTAEQ 50MG BASETABLET / ORALRLD2008-11-20301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N022304-002NUCYNTAEQ 75MG BASETABLET / ORALRLD2008-11-20301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N022304-003NUCYNTAEQ 100MG BASETABLET / ORALRLD, RS2008-11-20301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N022304-001NUCYNTAEQ 50MG BASETABLET / ORALRLD2008-11-201e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N022304-002NUCYNTAEQ 75MG BASETABLET / ORALRLD2008-11-201e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N022304-003NUCYNTAEQ 100MG BASETABLET / ORALRLD, RS2008-11-201e350fbaab3a…
2024-05-31 18:47 UTC2024-05N022304-001NUCYNTAEQ 50MG BASETABLET / ORALRLD2008-11-208072bd15b7f6…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02N022304-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022304-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022304-003AB1011fe1cb6892…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N022304-001AB1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N022304-002AB1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N022304-003AB1a50c72e98297…

Observed Orange Book patent history#

Patent history page 1 of 6 · 201 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022304-00179943642025-06-27U-931Drug substance, Drug product2011-09-0231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022304-0017994364*PED2025-12-27Pediatric extension31067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022304-00279943642025-06-27U-931Drug substance, Drug product31067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022304-0027994364*PED2025-12-27Pediatric extension31067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022304-00379943642025-06-27U-931Drug substance, Drug product31067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022304-0037994364*PED2025-12-27Pediatric extension31067a03dcf5…
2025-08-23 18:47 UTC2025-08N022304-00179943642025-06-27U-931Drug substance, Drug product2011-09-026a471c1ec25d…
2025-08-23 18:47 UTC2025-08N022304-0017994364*PED2025-12-27Pediatric extension6a471c1ec25d…
2025-08-23 18:47 UTC2025-08N022304-00279943642025-06-27U-931Drug substance, Drug product6a471c1ec25d…
2025-08-23 18:47 UTC2025-08N022304-0027994364*PED2025-12-27Pediatric extension6a471c1ec25d…
2025-08-23 18:47 UTC2025-08N022304-00379943642025-06-27U-931Drug substance, Drug product6a471c1ec25d…
2025-08-23 18:47 UTC2025-08N022304-0037994364*PED2025-12-27Pediatric extension6a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022304-00179943642025-06-27U-931Drug substance, Drug product2011-09-02fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022304-0017994364*PED2025-12-27Pediatric extensionfd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022304-00279943642025-06-27U-931Drug substance, Drug productfd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022304-0027994364*PED2025-12-27Pediatric extensionfd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022304-00379943642025-06-27U-931Drug substance, Drug productfd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022304-0037994364*PED2025-12-27Pediatric extensionfd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N022304-00179943642025-06-27U-931Drug substance, Drug product2011-09-02b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N022304-0017994364*PED2025-12-27Pediatric extensionb8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N022304-00279943642025-06-27U-931Drug substance, Drug productb8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N022304-0027994364*PED2025-12-27Pediatric extensionb8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N022304-00379943642025-06-27U-931Drug substance, Drug productb8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N022304-0037994364*PED2025-12-27Pediatric extensionb8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N022304-00179943642025-06-27U-931Drug substance, Drug product2011-09-0203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N022304-0017994364*PED2025-12-27Pediatric extension03ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N022304-00279943642025-06-27U-931Drug substance, Drug product03ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N022304-0027994364*PED2025-12-27Pediatric extension03ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N022304-00379943642025-06-27U-931Drug substance, Drug product03ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N022304-0037994364*PED2025-12-27Pediatric extension03ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N022304-00179943642025-06-27U-931Drug substance, Drug product2011-09-022680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N022304-0017994364*PED2025-12-27Pediatric extension2680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N022304-00279943642025-06-27U-931Drug substance, Drug product2680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N022304-0027994364*PED2025-12-27Pediatric extension2680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N022304-00379943642025-06-27U-931Drug substance, Drug product2680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N022304-0037994364*PED2025-12-27Pediatric extension2680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N022304-00179943642025-06-27U-931Drug substance, Drug product2011-09-025bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N022304-0017994364*PED2025-12-27Pediatric extension5bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N022304-00279943642025-06-27U-931Drug substance, Drug product5bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N022304-0027994364*PED2025-12-27Pediatric extension5bbf6a4d5a75…

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 3 · 96 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2026-02-19 14:30 UTC2026-02N022304-001NPP2026-07-03011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022304-001PED2027-01-03011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022304-002NPP2026-07-03011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022304-002PED2027-01-03011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022304-003NPP2026-07-03011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022304-003PED2027-01-03011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022304-001NPP2026-07-0331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022304-001PED2027-01-0331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022304-002NPP2026-07-0331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022304-002PED2027-01-0331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022304-003NPP2026-07-0331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022304-003PED2027-01-0331067a03dcf5…
2025-08-23 18:47 UTC2025-08N022304-001NPP2026-07-036a471c1ec25d…
2025-08-23 18:47 UTC2025-08N022304-001PED2027-01-036a471c1ec25d…
2025-08-23 18:47 UTC2025-08N022304-002NPP2026-07-036a471c1ec25d…
2025-08-23 18:47 UTC2025-08N022304-002PED2027-01-036a471c1ec25d…
2025-08-23 18:47 UTC2025-08N022304-003NPP2026-07-036a471c1ec25d…
2025-08-23 18:47 UTC2025-08N022304-003PED2027-01-036a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022304-001NPP2026-07-03fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022304-001PED2027-01-03fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022304-002NPP2026-07-03fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022304-002PED2027-01-03fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022304-003NPP2026-07-03fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022304-003PED2027-01-03fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N022304-001NPP2026-07-03b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N022304-001PED2027-01-03b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N022304-002NPP2026-07-03b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N022304-002PED2027-01-03b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N022304-003NPP2026-07-03b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N022304-003PED2027-01-03b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N022304-001NPP2026-07-0303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N022304-001PED2027-01-0303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N022304-002NPP2026-07-0303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N022304-002PED2027-01-0303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N022304-003NPP2026-07-0303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N022304-003PED2027-01-0303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N022304-001NPP2026-07-032680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N022304-001PED2027-01-032680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N022304-002NPP2026-07-032680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N022304-002PED2027-01-032680178bc6a6…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
279f6ab2-ad0d-a4be-abc3-377fa3441fa2Product name120140508
41331914-7851-9471-14c3-fea0cf65689eProduct name120140508
7142c439-ef45-40fb-d30b-dd20e4faf1c1Product name120140508

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50458-840-02EA - Each50458-8406c41e9b4-e311-4eb1-8a81-e4a05b7c7fef12012-07-24
50458-840-04EA - Each50458-840269a1fcd-d27c-424a-bfe9-54a660e58a7912012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
tapentadol hydrochlorideACTIVE INGREDIENT71204KII53NUCYNTA (TAPENTADOL HYDROCHLORIDE) TABLET, FILM COATED [JANSSEN PHARMACEUTICALS, INC.]8
tapentadolACTIVE MOIETYH8A007M585NUCYNTA (TAPENTADOL HYDROCHLORIDE) TABLET, FILM COATED [JANSSEN PHARMACEUTICALS, INC.]8
aluminum oxideINACTIVE INGREDIENTLMI26O6933NUCYNTA (TAPENTADOL HYDROCHLORIDE) TABLET, FILM COATED [JANSSEN PHARMACEUTICALS, INC.]8
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UNUCYNTA (TAPENTADOL HYDROCHLORIDE) TABLET, FILM COATED [JANSSEN PHARMACEUTICALS, INC.]8
croscarmellose sodiumINACTIVE INGREDIENTM28OL1HH48NUCYNTA (TAPENTADOL HYDROCHLORIDE) TABLET, FILM COATED [JANSSEN PHARMACEUTICALS, INC.]8
lactose monohydrateINACTIVE INGREDIENTEWQ57Q8I5XNUCYNTA (TAPENTADOL HYDROCHLORIDE) TABLET, FILM COATED [JANSSEN PHARMACEUTICALS, INC.]8
magnesium stearateINACTIVE INGREDIENT70097M6I30NUCYNTA (TAPENTADOL HYDROCHLORIDE) TABLET, FILM COATED [JANSSEN PHARMACEUTICALS, INC.]8
polyethylene glycolsINACTIVE INGREDIENT3WJQ0SDW1ANUCYNTA (TAPENTADOL HYDROCHLORIDE) TABLET, FILM COATED [JANSSEN PHARMACEUTICALS, INC.]8
polyvinyl alcoholINACTIVE INGREDIENT532B59J990NUCYNTA (TAPENTADOL HYDROCHLORIDE) TABLET, FILM COATED [JANSSEN PHARMACEUTICALS, INC.]8
povidonesINACTIVE INGREDIENTFZ989GH94ENUCYNTA (TAPENTADOL HYDROCHLORIDE) TABLET, FILM COATED [JANSSEN PHARMACEUTICALS, INC.]8
talcINACTIVE INGREDIENT7SEV7J4R1UNUCYNTA (TAPENTADOL HYDROCHLORIDE) TABLET, FILM COATED [JANSSEN PHARMACEUTICALS, INC.]8
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPNUCYNTA (TAPENTADOL HYDROCHLORIDE) TABLET, FILM COATED [JANSSEN PHARMACEUTICALS, INC.]8
tapentadol hydrochlorideACTIVE INGREDIENT71204KII53NUCYNTA (TAPENTADOL HYDROCHLORIDE) TABLET, FILM COATED [STAT RX USA]2
TAPENTADOL HYDROCHLORIDEACTIVE INGREDIENT71204KII53NUCYNTA (TAPENTADOL HYDROCHLORIDE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]2
tapentadolACTIVE MOIETYH8A007M585NUCYNTA (TAPENTADOL HYDROCHLORIDE) TABLET, FILM COATED [STAT RX USA]2
TAPENTADOLACTIVE MOIETYH8A007M585NUCYNTA (TAPENTADOL HYDROCHLORIDE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]2
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933NUCYNTA (TAPENTADOL HYDROCHLORIDE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]2
aluminum oxideINACTIVE INGREDIENTLMI26O6933NUCYNTA (TAPENTADOL HYDROCHLORIDE) TABLET, FILM COATED [STAT RX USA]2
cellulose, microcrystallineINACTIVE INGREDIENTOP1R32D61UNUCYNTA (TAPENTADOL HYDROCHLORIDE) TABLET, FILM COATED [STAT RX USA]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UNUCYNTA (TAPENTADOL HYDROCHLORIDE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]2
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48NUCYNTA (TAPENTADOL HYDROCHLORIDE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]2
croscarmellose sodiumINACTIVE INGREDIENTM28OL1HH48NUCYNTA (TAPENTADOL HYDROCHLORIDE) TABLET, FILM COATED [STAT RX USA]2
lactose monohydrateINACTIVE INGREDIENTEWQ57Q8I5XNUCYNTA (TAPENTADOL HYDROCHLORIDE) TABLET, FILM COATED [STAT RX USA]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XNUCYNTA (TAPENTADOL HYDROCHLORIDE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30NUCYNTA (TAPENTADOL HYDROCHLORIDE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]2
magnesium stearateINACTIVE INGREDIENT70097M6I30NUCYNTA (TAPENTADOL HYDROCHLORIDE) TABLET, FILM COATED [STAT RX USA]2
polyethylene glycolINACTIVE INGREDIENT3WJQ0SDW1ANUCYNTA (TAPENTADOL HYDROCHLORIDE) TABLET, FILM COATED [STAT RX USA]2
POLYETHYLENE GLYCOLINACTIVE INGREDIENT3WJQ0SDW1ANUCYNTA (TAPENTADOL HYDROCHLORIDE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]2
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990NUCYNTA (TAPENTADOL HYDROCHLORIDE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]2
polyvinyl alcoholINACTIVE INGREDIENT532B59J990NUCYNTA (TAPENTADOL HYDROCHLORIDE) TABLET, FILM COATED [STAT RX USA]2
povidoneINACTIVE INGREDIENTFZ989GH94ENUCYNTA (TAPENTADOL HYDROCHLORIDE) TABLET, FILM COATED [STAT RX USA]2
POVIDONEINACTIVE INGREDIENTFZ989GH94ENUCYNTA (TAPENTADOL HYDROCHLORIDE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]2
talcINACTIVE INGREDIENT7SEV7J4R1UNUCYNTA (TAPENTADOL HYDROCHLORIDE) TABLET, FILM COATED [STAT RX USA]2
TALCINACTIVE INGREDIENT7SEV7J4R1UNUCYNTA (TAPENTADOL HYDROCHLORIDE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]2
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPNUCYNTA (TAPENTADOL HYDROCHLORIDE) TABLET, FILM COATED [STAT RX USA]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPNUCYNTA (TAPENTADOL HYDROCHLORIDE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TAPENTADOLTAPENTADOL HYDROCHLORIDEHikma Pharmaceuticals USA Inc.863f3fd3-1e8d-41b0-855f-8f9a29237cda2026-02-26Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 022304
application number: NDA022304
NucyntaTAPENTADOL HYDROCHLORIDECollegium Pharmaceutical, Inc.80938c30-9fe3-4c7d-9d9c-5476638cfb2d2025-12-30Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 022304
application number: NDA022304

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
854140NUCYNTA 100 MG Oral TabletPSNe35e8385-db1f-41a8-8307-20979569ac722
854140NUCYNTA 100 MG Oral TabletPSN4a6953cd-9d64-4443-b7db-5aef2c81324d2
854142NUCYNTA 50 MG Oral TabletPSN4a6953cd-9d64-4443-b7db-5aef2c81324d2
854142NUCYNTA 50 MG Oral TabletPSNe35e8385-db1f-41a8-8307-20979569ac722
854144NUCYNTA 75 MG Oral TabletPSN4a6953cd-9d64-4443-b7db-5aef2c81324d2
825409tapentadol 100 MG Oral TabletPSNe35e8385-db1f-41a8-8307-20979569ac722
825409tapentadol 100 MG Oral TabletPSN4a6953cd-9d64-4443-b7db-5aef2c81324d2
825411tapentadol 50 MG Oral TabletPSNe35e8385-db1f-41a8-8307-20979569ac722
825411tapentadol 50 MG Oral TabletPSN4a6953cd-9d64-4443-b7db-5aef2c81324d2
825413tapentadol 75 MG Oral TabletPSN4a6953cd-9d64-4443-b7db-5aef2c81324d2
854140tapentadol 100 MG Oral Tablet [Nucynta]SBD4a6953cd-9d64-4443-b7db-5aef2c81324d2
854140tapentadol 100 MG Oral Tablet [Nucynta]SBDe35e8385-db1f-41a8-8307-20979569ac722
854142tapentadol 50 MG Oral Tablet [Nucynta]SBDe35e8385-db1f-41a8-8307-20979569ac722
854142tapentadol 50 MG Oral Tablet [Nucynta]SBD4a6953cd-9d64-4443-b7db-5aef2c81324d2
854144tapentadol 75 MG Oral Tablet [Nucynta]SBD4a6953cd-9d64-4443-b7db-5aef2c81324d2
825409tapentadol 100 MG Oral TabletSCDe35e8385-db1f-41a8-8307-20979569ac722
825409tapentadol 100 MG Oral TabletSCD4a6953cd-9d64-4443-b7db-5aef2c81324d2
825411tapentadol 50 MG Oral TabletSCDe35e8385-db1f-41a8-8307-20979569ac722
825411tapentadol 50 MG Oral TabletSCD4a6953cd-9d64-4443-b7db-5aef2c81324d2
825413tapentadol 75 MG Oral TabletSCD4a6953cd-9d64-4443-b7db-5aef2c81324d2
854140Nucynta 100 MG Oral TabletSY4a6953cd-9d64-4443-b7db-5aef2c81324d2
854140Nucynta 100 MG Oral TabletSYe35e8385-db1f-41a8-8307-20979569ac722
854142Nucynta 50 MG Oral TabletSYe35e8385-db1f-41a8-8307-20979569ac722
854142Nucynta 50 MG Oral TabletSY4a6953cd-9d64-4443-b7db-5aef2c81324d2
854144Nucynta 75 MG Oral TabletSY4a6953cd-9d64-4443-b7db-5aef2c81324d2
825409tapentadol 100 MG (as tapentadol hydrochloride) Oral TabletSYe35e8385-db1f-41a8-8307-20979569ac722
825409tapentadol 100 MG (as tapentadol hydrochloride) Oral TabletSY4a6953cd-9d64-4443-b7db-5aef2c81324d2
825411tapentadol 50 MG (as tapentadol hydrochloride) Oral TabletSYe35e8385-db1f-41a8-8307-20979569ac722
825411tapentadol 50 MG (as tapentadol hydrochloride) Oral TabletSY4a6953cd-9d64-4443-b7db-5aef2c81324d2
825413tapentadol 75 MG (as tapentadol hydrochloride) Oral TabletSY4a6953cd-9d64-4443-b7db-5aef2c81324d2