Application 020281

Type
NDA
Sponsor
JANSSEN PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ULTRAMTRAMADOL HYDROCHLORIDETABLET;ORAL100MGNoNo
002ULTRAMTRAMADOL HYDROCHLORIDETABLET;ORAL50MGYesYes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N020281-001ULTRAMTRAMADOL HYDROCHLORIDE100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1995-03-03
N020281-002ULTRAMTRAMADOL HYDROCHLORIDE50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1995-03-03

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 3 · 86 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08N020281-001ULTRAM100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1995-03-0384e616aacf4f…
2026-09-14 22:38:342026-08N020281-002ULTRAM50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1995-03-0384e616aacf4f…
2026-08-18 06:07:402026-07N020281-001ULTRAM100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1995-03-03caaa826d4ba7…
2026-08-18 06:07:402026-07N020281-002ULTRAM50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1995-03-03caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N020281-001ULTRAM100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1995-03-03011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020281-002ULTRAM50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1995-03-03011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020281-001ULTRAM100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1995-03-0331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020281-002ULTRAM50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1995-03-0331067a03dcf5…
2025-08-23 18:47 UTC2025-08N020281-001ULTRAM100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1995-03-036a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020281-002ULTRAM50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1995-03-036a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020281-001ULTRAM100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1995-03-03fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020281-002ULTRAM50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1995-03-03fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020281-001ULTRAM100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1995-03-03b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020281-002ULTRAM50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1995-03-03b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020281-001ULTRAM100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1995-03-0303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020281-002ULTRAM50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1995-03-0303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020281-001ULTRAM100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1995-03-032680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020281-002ULTRAM50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1995-03-032680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020281-001ULTRAM100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1995-03-035bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020281-002ULTRAM50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1995-03-035bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020281-001ULTRAM100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1995-03-03d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020281-002ULTRAM50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1995-03-03d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N020281-001ULTRAM100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1995-03-03d06236e962d9…
2024-10-29 15:01 UTC2024-10N020281-002ULTRAM50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1995-03-03d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N020281-001ULTRAM100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1995-03-0379d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N020281-002ULTRAM50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1995-03-0379d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N020281-001ULTRAM100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1995-03-03301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N020281-002ULTRAM50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1995-03-03301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N020281-001ULTRAM100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1995-03-031e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N020281-002ULTRAM50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1995-03-031e350fbaab3a…
2024-05-31 18:47 UTC2024-05N020281-001ULTRAM100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1995-03-038072bd15b7f6…
2024-05-31 18:47 UTC2024-05N020281-002ULTRAM50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1995-03-038072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N020281-001ULTRAM100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORAL1995-03-035c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N020281-002ULTRAM50MGTABLET / ORALABRLD, RS1995-03-035c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N020281-001ULTRAM100MGTABLET / ORAL1995-03-035d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N020281-002ULTRAM50MGTABLET / ORALABRLD, RS1995-03-035d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N020281-001ULTRAM100MGTABLET / ORAL1995-03-034b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N020281-002ULTRAM50MGTABLET / ORALABRLD, RS1995-03-034b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N020281-001ULTRAM100MGTABLET / ORAL1995-03-0374a2ff9319b5…
2019-12-13 00:20 UTC2019-12N020281-002ULTRAM50MGTABLET / ORALABRLD, RS1995-03-0374a2ff9319b5…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N020281-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N020281-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N020281-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N020281-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03N020281-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N020281-002AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N020281-002AB187673890dc5c…
2021-03-12 10:30 UTC2021-03N020281-002AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N020281-002AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11N020281-002AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12N020281-002AB13f01610625f2…
2019-09-15 20:21 UTC2019-09N020281-002AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07N020281-002AB1ea99ee380514…
2022-09-29 23:25 UTC2022-09N020281-002AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N020281-002AB1cb3db0bc1861…

Observed Orange Book patent history#

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2019-12-13 00:20 UTC2019-12N020281-00163391052019-10-12U-43574a2ff9319b5…
2019-12-13 00:20 UTC2019-12N020281-0016339105*PED2020-04-12Pediatric extension74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N020281-00263391052019-10-12U-43574a2ff9319b5…
2019-12-13 00:20 UTC2019-12N020281-0026339105*PED2020-04-12Pediatric extension74a2ff9319b5…
2020-12-22 03:56 UTC2020-12N020281-0016339105*PED2020-04-12Pediatric extension8869cabd3fbd…
2020-12-22 03:56 UTC2020-12N020281-0026339105*PED2020-04-12Pediatric extension8869cabd3fbd…
2020-11-12 02:37 UTC2020-11N020281-0016339105*PED2020-04-12Pediatric extensionc0c555d07b60…
2020-11-12 02:37 UTC2020-11N020281-0026339105*PED2020-04-12Pediatric extensionc0c555d07b60…
2019-12-14 00:12 UTC2019-12N020281-00163391052019-10-12U-4353f01610625f2…
2019-12-14 00:12 UTC2019-12N020281-0016339105*PED2020-04-12Pediatric extension3f01610625f2…
2019-12-14 00:12 UTC2019-12N020281-00263391052019-10-12U-4353f01610625f2…
2019-12-14 00:12 UTC2019-12N020281-0026339105*PED2020-04-12Pediatric extension3f01610625f2…
2019-09-15 20:21 UTC2019-09N020281-00163391052019-10-12U-435b00525d2431f…
2019-09-15 20:21 UTC2019-09N020281-0016339105*PED2020-04-12Pediatric extensionb00525d2431f…
2019-09-15 20:21 UTC2019-09N020281-00263391052019-10-12U-435b00525d2431f…
2019-09-15 20:21 UTC2019-09N020281-0026339105*PED2020-04-12Pediatric extensionb00525d2431f…
2019-07-19 19:46 UTC2019-07N020281-00163391052019-10-12U-435ea99ee380514…
2019-07-19 19:46 UTC2019-07N020281-0016339105*PED2020-04-12Pediatric extensionea99ee380514…
2019-07-19 19:46 UTC2019-07N020281-00263391052019-10-12U-435ea99ee380514…
2019-07-19 19:46 UTC2019-07N020281-0026339105*PED2020-04-12Pediatric extensionea99ee380514…

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 4 of 5 · 91 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TRAMADOL HYDROCHLORIDETRAMADOL HYDROCHLORIDECranbury Pharmaceuticals, LLC1d4af58f-17f3-4cbd-870c-098ace9548722024-12-31Boxed warning, Warnings, Adverse reactionsName fallback
generic name: TRAMADOL HYDROCHLORIDE
Tramadol HydrochlorideTRAMADOL HYDROCHLORIDEAdvanced Rx Pharmacy of Tennessee, LLCf4ea18b0-2cbd-0d42-e053-2995a90a92642024-12-31Boxed warning, Warnings, Adverse reactionsName fallback
generic name: TRAMADOL HYDROCHLORIDE
Tramadol HydrochlorideTRAMADOL HYDROCHLORIDEQuality Care Products, LLCf79fda81-f09a-4a08-babc-6bd3bb3ee6612024-12-19Boxed warning, Warnings, Adverse reactionsName fallback
generic name: TRAMADOL HYDROCHLORIDE
TRAMADOL HYDROCHLORIDETRAMADOL HYDROCHLORIDEQuality Care Products, LLC68484531-f908-473f-a422-f37234de96912024-12-19Boxed warning, Warnings, Adverse reactionsName fallback
generic name: TRAMADOL HYDROCHLORIDE
TRAMADOL HYDROCHLORIDETRAMADOL HYDROCHLORIDEQuality Care Products, LLC7e421fb6-737c-49b3-b299-50511e281a4d2024-12-19Boxed warning, Warnings, Adverse reactionsName fallback
generic name: TRAMADOL HYDROCHLORIDE
Tramadol HydrochlorideTRAMADOL HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLC27460cc6-0782-7838-e063-6394a90a19f12024-11-18Boxed warning, Warnings, Adverse reactionsName fallback
generic name: TRAMADOL HYDROCHLORIDE
tramadol hydrochlorideTRAMADOL HYDROCHLORIDEBryant Ranch Prepack6ebc5864-c222-4400-a9b2-f66fd6fb0da62024-11-04Boxed warning, Warnings, Adverse reactionsName fallback
generic name: TRAMADOL HYDROCHLORIDE
TRAMADOL HCL ERTRAMADOL HCLDIRECT RX5285f056-c32c-4e7a-bec6-3a726aa23d5a2024-10-17Boxed warning, Warnings, Adverse reactionsName fallback
generic name: TRAMADOL HYDROCHLORIDE
tramadol hydrochlorideTRAMADOL HYDROCHLORIDENuCare Pharmaceuticals, Inc.1cd3caee-bf54-7aba-e063-6394a90ad8cb2024-10-04Boxed warning, Warnings, Adverse reactionsName fallback
generic name: TRAMADOL HYDROCHLORIDE
Tramadol HydrochlorideTRAMADOL HYDROCHLORIDEAdvanced Rx Pharmacy of Tennessee, LLCf44c53ec-26ea-d272-e053-2a95a90a5e592024-09-09Boxed warning, Warnings, Adverse reactionsName fallback
generic name: TRAMADOL HYDROCHLORIDE
TRAMADOL HYDROCHLORIDETRAMADOL HYDROCHLORIDEBryant Ranch Prepack8cc09b31-6067-44ec-8aba-ea7bb1a1f4482024-08-28Boxed warning, Warnings, Adverse reactionsName fallback
generic name: TRAMADOL HYDROCHLORIDE
TRAMADOL HYDROCHLORIDETRAMADOL HYDROCHLORIDEBryant Ranch Prepackb2f3f007-6dda-4532-9f7f-d93f6e65254c2024-08-28Boxed warning, Warnings, Adverse reactionsName fallback
generic name: TRAMADOL HYDROCHLORIDE
TRAMADOL HYDROCHLORIDETRAMADOL HYDROCHLORIDENuCare Pharmaceuticals,Inc.93c9c960-afbf-6d3d-e053-2995a90a8d152024-07-15Boxed warning, Warnings, Adverse reactionsName fallback
generic name: TRAMADOL HYDROCHLORIDE
tramadol hydrochlorideTRAMADOL HYDROCHLORIDEProficient Rx LP2236031d-8596-4c21-8b16-83aa3e4122c12024-07-01Boxed warning, Warnings, Adverse reactionsName fallback
generic name: TRAMADOL HYDROCHLORIDE
TRAMADOL HYDROCHLORIDETRAMADOL HYDROCHLORIDENuCare Pharmaceuticals,Inc.93e129c8-64c4-1f6d-e053-2a95a90ac1f82024-06-19Boxed warning, Warnings, Adverse reactionsName fallback
generic name: TRAMADOL HYDROCHLORIDE
Tramadol HydrochlorideTRAMADOL HYDROCHLORIDEProficient Rx LPe90d4ef3-8b90-41b7-bf96-340852e89b5f2024-04-01Boxed warning, Warnings, Adverse reactionsName fallback
generic name: TRAMADOL HYDROCHLORIDE
TRAMADOL HYDROCHLORIDETRAMADOL HYDROCHLORIDEMedsource Pharmaceuticals1278980b-4068-df57-e063-6394a90a87422024-02-28Boxed warning, Warnings, Adverse reactionsName fallback
generic name: TRAMADOL HYDROCHLORIDE
Tramadol HydrochlorideTRAMADOL HYDROCHLORIDELupin Pharmaceuticals, Inc.3e0ccb95-3e8e-477c-b4d2-6060ee05f9302023-12-11Warnings, Adverse reactionsName fallback
generic name: TRAMADOL HYDROCHLORIDE
TRAMADOL HYDROCHLORIDETRAMADOL HYDROCHLORIDEAsclemed USA, Inc.a26ca887-e26c-4c32-8dbd-1fa2eb6db9dc2023-02-15Boxed warning, Warnings, Adverse reactionsName fallback
generic name: TRAMADOL HYDROCHLORIDE
Tramadol HydrochlorideTRAMADOL HYDROCHLORIDETruPharma, LLCaea56ff9-94ac-47a8-8f15-8790d538973b2023-01-25Boxed warning, Warnings, Adverse reactionsName fallback
generic name: TRAMADOL HYDROCHLORIDE

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 · 7 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
50458-659ULTRAMtramadol hydrochlorideJanssen Pharmaceuticals, Inc.NDACurrent
50458-659ULTRAMtramadol hydrochlorideJanssen Pharmaceuticals, Inc.NDACurrent
50458-659ULTRAMtramadol hydrochlorideJanssen Pharmaceuticals, Inc.NDACurrent
50458-659ULTRAMtramadol hydrochlorideJanssen Pharmaceuticals, NDACurrent
50458-659ULTRAMtramadol hydrochlorideJanssen Pharmaceuticals, Inc.NDACurrent
50458-659ULTRAMtramadol hydrochlorideJanssen Pharmaceuticals, Inc.NDACurrent
50458-659ULTRAMtramadol hydrochlorideJanssen Pharmaceuticals, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
76230ORIG 2023-11-03
73501SUPPL 2023-02-14
73500SUPPL 2023-02-14
73491SUPPL 2023-02-14
68609SUPPL2021-09-14
68608SUPPL2021-09-13
68607SUPPL2021-09-13
66585SUPPL2021-03-08
66584SUPPL2021-03-08
66506SUPPL2021-03-05
60342SUPPL2019-10-08
60327SUPPL2019-10-08
60326SUPPL2019-10-08
58278SUPPL2019-04-10
58263SUPPL2019-04-09
57644ORIG2019-02-15
55875SUPPL2018-10-11
55874SUPPL2018-10-11
55679SUPPL2018-10-01
55678SUPPL2018-10-01
49625SUPPL2017-08-30
49595SUPPL2017-08-30
46386SUPPL2016-12-21
46385SUPPL2016-12-21
46252SUPPL2016-12-20
46251SUPPL2016-12-20
24731SUPPL2009-11-12
24730SUPPL2009-11-12
34472SUPPL2009-10-06
12419SUPPL2009-10-06
24728SUPPL2004-06-29
24727SUPPL2004-06-29
34471SUPPL2004-05-03
2293SUPPL2004-04-20
20585SUPPL2003-08-07
20584SUPPL2003-08-07
34470SUPPL2003-04-22
34469SUPPL1999-12-23
24729SUPPL1999-12-23