FDA.reportPublic FDA data

NDC 58118-4459-08 - Buprenorphine

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
58118-4459
Requested NDC
58118-4459-08
Package NDCs from labels
58118-4459-8, 58118-4459-08
Manufacturer
Clinical Solutions Wholesale, LLC
Effective date
2025-02-17
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Buprenorphine - Clinical Solutions Wholesale, LLCClinical Solutions Wholesale, LLC2025-02-17HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58118-4459-8Buprenorphine30 in 1 BLISTER PACKTABLET301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58118-4459BUPRENORPHINE TABLET [CLINICAL SOLUTIONS WHOLESALE, LLC]1Current NDC, 1 package rows20250221_9d976ee7-9509-49da-89fd-48d7e712697b.zip

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 15 · 297 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GOOD NEIGHBOR PHARMACY ARTIFICAL TEARS LUBRICANT EYE DROPSPOLYVINYL ALCOHOL, POVIDONEAmerisourceBergence6852a8-c5e6-403d-a7b4-a2e85d1ebb1f2026-07-22WarningsExact identifier
unii: FZ989GH94E
XenletaLEFAMULIN ACETATEMeitheal Pharmaceuticals Inc.eb972ea8-7502-422e-84bb-66cb8e93ca062026-07-22Warnings, Adverse reactionsExact identifier
unii: XF417D3PSL
buprenorphine hydrochlorideBUPRENORPHINE HYDROCHLORIDEAdvagen Pharma Ltd699638dd-3a53-445f-a545-d0e6eabfe1c92026-07-17Warnings, Adverse reactionsExact identifier
rxcui: 351265
rxcui: 351264
unii: 56W8MW3EN1
Buprenorphine HClBUPRENORPHINE HCLREMEDYREPACK INC.e1aac2bb-cb83-46cb-9a29-502a620106672026-07-17Warnings, Adverse reactionsExact identifier
rxcui: 351264
unii: 56W8MW3EN1
BuprenorphineBUPRENORPHINEREMEDYREPACK INC.aa86a438-1ebf-4c08-bf27-38f1e81efb3a2026-07-07Warnings, Adverse reactionsExact identifier
rxcui: 351264
unii: 56W8MW3EN1
buprenorphine hydrochlorideBUPRENORPHINE HYDROCHLORIDEREMEDYREPACK INC.11686845-f5fd-4e96-8a4f-9b132bf488402026-07-07Warnings, Adverse reactionsExact identifier
rxcui: 351265
unii: 56W8MW3EN1
BUPRENORPHINEBUPRENORPHINEUnit Dose Solutions, Inc.5578cd5c-c860-6e8a-e063-6394a90a56c72026-06-30Warnings, Adverse reactionsExact identifier
rxcui: 351265
unii: 56W8MW3EN1
BUPRENORPHINEBUPRENORPHINEBryant Ranch Prepackaa132031-9d12-45b4-81e0-4a58776613792026-06-29Warnings, Adverse reactionsExact identifier
rxcui: 351265
unii: 56W8MW3EN1
BuprenorphineBUPRENORPHINEBryant Ranch Prepack655e3e52-03be-496c-978a-5cffc74b2ae42026-06-29Warnings, Adverse reactionsExact identifier
application number: ANDA201760
rxcui: 351265
unii: 56W8MW3EN1
BUPRENORPHINE AND NALOXONEBUPRENORPHINE AND NALOXONEAscend Laboratories, LLC2e807ed0-6df3-47b5-b7ee-b421c5bf0aa72026-06-29Warnings, Adverse reactionsExact identifier
unii: 56W8MW3EN1
Rohto Sun and SportHYPROMELLOSE, POVIDONEThe Mentholatum Company8bcc8882-b886-4b55-9bc4-d4b92a41358f2026-06-19WarningsExact identifier
unii: FZ989GH94E
Rohto Dual Light ReliefHYPROMELLOSE, POVIDONEThe Mentholatum Company1b597f83-d7f1-cf93-e063-6394a90a99f72026-06-19WarningsExact identifier
unii: FZ989GH94E
BUPRENORPHINEBUPRENORPHINEUnit Dose Solutions, Inc.5479b218-a388-2c3c-e063-6294a90a0e852026-06-17Warnings, Adverse reactionsExact identifier
rxcui: 351264
unii: 56W8MW3EN1
BUPRENORPHINEBUPRENORPHINEBryant Ranch Prepack966adb01-71b4-4e0b-bbc6-b83da9987aa22026-06-16Warnings, Adverse reactionsExact identifier
rxcui: 351265
unii: 56W8MW3EN1
BuprenorphineBUPRENORPHINEMajor Pharmaceuticalsdba586f9-e3f2-4b9c-849b-907c81a5a0ef2026-06-16Warnings, Adverse reactionsExact identifier
rxcui: 351265
rxcui: 351264
unii: 56W8MW3EN1
Buprenorphine and NaloxoneBUPRENORPHINE AND NALOXONEBryant Ranch Prepackfe023dbf-e165-4b7f-a211-bd14696f1e2c2026-06-16Warnings, Adverse reactionsExact identifier
unii: 56W8MW3EN1
Buprenorphine and NaloxoneBUPRENORPHINE AND NALOXONEBryant Ranch Prepack4b1df792-f56c-4c0c-92b0-a887f42255672026-06-16Warnings, Adverse reactionsExact identifier
unii: 56W8MW3EN1
E-Z-GAS IIANTACID/ANTIFLATULENTE-Z-EM, INC.4e12e1cb-b033-076d-e054-00144ff8d46c2026-06-15WarningsExact identifier
unii: XF417D3PSL
Buprenorphine and Naloxone Sublingual FilmBUPRENORPHINE AND NALOXONERedpharm Drug541bf5be-8b2c-99bc-e063-6294a90a2f172026-06-13Warnings, Adverse reactionsExact identifier
unii: 56W8MW3EN1
ZubsolvBUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDEEdenbridge Pharmaceuticals LLC.57583c1d-9c44-4503-917d-68dba7377bd12026-06-12Warnings, Adverse reactionsExact identifier
unii: 56W8MW3EN1