FDA.reportPublic FDA data

NDC 0781-7249-06 - BUPRENORPHINE AND NALOXONE

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
0781-7249
Requested NDC
0781-7249-06
Package NDCs from labels
0781-7249-06, 0781-7249-64
Manufacturer
Indivior Inc.
Effective date
2021-04-19
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
BUPRENORPHINE AND NALOXONE - Indivior Inc.Indivior Inc.2021-04-19HUMAN PRESCRIPTION DRUG LABEL

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0781-7249-06EA - Each0781-72491bb36689-3c63-4b20-b327-05bc578f533712019-10-07
0781-7249-64EA - Each0781-7249064c1984-7eb1-4e07-8102-b7b4b7aeabae12019-03-12

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 3 of 15 · 281 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Buprenorphine Hydrochloride and Naloxone Hydrochloride DihydrateBUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE DIHYDRATESpecGx LLC62abde41-46cb-4e90-a798-23d6531bf9aa2026-06-10Warnings, Adverse reactionsExact identifier
unii: 56W8MW3EN1
Buprenorphine HCl and Naloxone HClBUPRENORPHINE AND NALOXONEBryant Ranch Prepacke82e2d74-33a8-4894-82f6-788fc0f9feec2026-06-08Warnings, Adverse reactionsExact identifier
unii: 56W8MW3EN1
Buprenorphine HClBUPRENORPHINE HCLSpecGx LLCb60d514d-a88a-4fa2-a5b0-30ac29e049732026-06-05Warnings, Adverse reactionsExact identifier
unii: 56W8MW3EN1
Naloxone HydrochlorideNALOXONE HYDROCHLORIDEA-S Medication Solutions5906381c-81f4-4635-867a-e56e4d6296922026-06-03Warnings, Adverse reactionsExact identifier
unii: F850569PQR
Rohto Digi-EyeHYPROMELLOSE, TETRAHYDROZOLINE HYDROCHLORIDEThe Mentholatum Company5d6f37b9-b568-4cb6-92de-eb40779f3f8c2026-06-03WarningsExact identifier
unii: 3NXW29V3WO
Buprenorphine and NaloxoneBUPRENORPHINE AND NALOXONEBryant Ranch Prepackdd3bfccd-86a1-413f-affd-187f81dd07aa2026-06-03Warnings, Adverse reactionsExact identifier
unii: 56W8MW3EN1
Buprenorphine and NaloxoneBUPRENORPHINE AND NALOXONEBryant Ranch Prepackdd6e4fc9-a6f7-458a-b075-d736ce8b71722026-06-03Warnings, Adverse reactionsExact identifier
unii: 56W8MW3EN1
BUPRENORPHINEBUPRENORPHINEBryant Ranch Prepackbc5a7137-9e8f-438e-84d9-bdbf1db129982026-06-03Warnings, Adverse reactionsExact identifier
unii: 56W8MW3EN1
Naloxone HydrochlorideNALOXONE HYDROCHLORIDEHospira, Inc.8535cc84-ad4a-4d67-8480-fb5a2e3406f82026-05-27Warnings, Adverse reactionsExact identifier
unii: F850569PQR
BuprenorphineBUPRENORPHINEActavis Pharma, Inc.03819118-86f6-4329-adaf-4599e7b71f462026-05-25Warnings, Adverse reactionsExact identifier
unii: 56W8MW3EN1
Buprenorphine and NaloxoneBUPRENORPHINE AND NALOXONEREMEDYREPACK INC.072b2c2e-a564-4bb4-8954-9349a79238072026-05-22Warnings, Adverse reactionsExact identifier
unii: 56W8MW3EN1
ACD ACITRIC ACID MONOHYDRATE, DEXTROSE MONOHYDRATE, AND TRISODIUM CITRATE DIHYDRATETerumo BCT, Ltd8e255bc7-a120-460a-a32d-43931f8115de2026-05-21Warnings, Adverse reactionsExact identifier
unii: 2968PHW8QP
Buprenorphine Hydrochloride and Naloxone Hydrochloride DihydrateBUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE DIHYDRATEBryant Ranch Prepackb9b5b1d5-482e-42ad-aabd-869e9ade51262026-05-14Warnings, Adverse reactionsExact identifier
unii: 56W8MW3EN1
buprenorphine hydrochloride and naloxone hydrochloride dihydrateBUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE DIHYDRATEBryant Ranch Prepacka0f8c28c-ed9a-4a26-91a3-b996c117ac2c2026-05-14Warnings, Adverse reactionsExact identifier
unii: 56W8MW3EN1
buprenorphine hydrochloride and naloxone hydrochloride dihydrateBUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE DIHYDRATEBryant Ranch Prepackd25b1a73-9794-4e86-82eb-dee3f159a2142026-05-13Warnings, Adverse reactionsExact identifier
unii: 56W8MW3EN1
Naloxone HydrochlorideNALOXONE HYDROCHLORIDESomerset Therapeutics, LLCdfa48492-d83b-48cc-9ad1-bdc0c2ac99312026-05-05Warnings, Adverse reactionsExact identifier
unii: F850569PQR
BUPRENORPHINEBUPRENORPHINERhodes Pharmaceuticals LLCda90618a-5621-4b15-bc48-9dcc631418de2026-05-04Warnings, Adverse reactionsExact identifier
unii: 56W8MW3EN1
Buprenorphine and NaloxoneBUPRENORPHINE AND NALOXONERhodes Pharmaceuticals LLC794724a6-0fba-bc8d-ecdb-9e3be8ea21912026-05-01Warnings, Adverse reactionsExact identifier
unii: 56W8MW3EN1
NARCANNALOXONE HYDROCHLORIDE NASALSportpharm LLC3d43b2a2-9cc3-4c14-8ae7-fea4c83a7f922026-04-24WarningsExact identifier
unii: F850569PQR
buprenorphine hydrochloride and naloxone hydrochloride dihydrateBUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE DIHYDRATEGolden State Medical Supply, Inc.4f6e0056-b19d-0d0e-e063-6294a90a16e52026-04-24Warnings, Adverse reactionsExact identifier
unii: 56W8MW3EN1

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.