buprenorphine

Manufacturer
PAYLESS COMPOUNDERS, LLC
Effective date
2015-10-29
Label type
ANIMAL COMPOUNDED DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 02:48:08

Label at a glance#

Productbuprenorphine
Active ingredientBUPRENORPHINE HYDROCHLORIDE
Label structure1 sections

Label contents#

Full prescribing information#

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Buprenorphine MDV 0.3mg/mL
Buprenorphine MDV 0.3mg/mL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
238129buprenorphine HCl 0.3 MG in 1 ML InjectionPSN3
2381291 ML buprenorphine 0.3 MG/ML InjectionSCD3
238129buprenorphine 0.3 MG/ML (as buprenorphine HCl 0.324 MG/ML) InjectionSY3
238129buprenorphine HCl 0.3 MG per 1 ML InjectionSY3

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
BUPRENORPHINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
68654759-f50b-79ef-24c5-544d94fe7d87Product name320251114
08a295bb-88df-4ab0-a120-a75a789a74f1Product name120231013
cb89b86a-369e-4204-8910-ae797c503af3Product name120230706
ab841ac7-728a-4fc9-be0a-35b96cecbf39Product name420230306
100316cc-94a9-474e-97ad-9b5c6ddec605Product name520230125
539bc5d3-546b-4af6-9c31-058ce6c459d3Product name220220210
b871fccd-1de6-4c7f-b9e5-045304641ee6Product name820220118
d4880ace-a516-8c47-8dfd-73a4ba5887d7Product name220180830
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
31e16ab2-c562-4617-a3e8-ed285320e16eProduct name120180201
4c23a34c-e8fc-424c-8fa0-ee064ba6eaefProduct name120170706
a5920611-4285-f024-69b9-39ff338b81eaProduct name520170609
3df867ed-9d48-45cf-bded-1394beaea0b1Product name320161206
973da5bf-b1f9-4de0-81ee-7ca066c98ca4Product name120160712
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70022-001-10buprenorphine10 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION103

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70022-001BUPRENORPHINE INJECTION, SOLUTION [PAYLESS COMPOUNDERS, LLC]31 package rows20151030_7fc0c3fd-5122-43ce-995d-a55a7ea02371.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
BUPRENORPHINE HYDROCHLORIDEACTIVE INGREDIENT56W8MW3EN13
BUPRENORPHINEACTIVE MOIETY40D3SCR4GZ3
ANHYDROUS DEXTROSEINACTIVE INGREDIENT5SL0G7R0OK3
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBH3
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CB3
MANNITOLINACTIVE INGREDIENT3OWL53L36A3
WATERINACTIVE INGREDIENT059QF0KO0R3

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70022-00170022-001-10

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 5 · 277 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
ANHYDROUS DEXTROSEANHYDROUS DEXTROSE5SL0G7R0OKINJECTION / SUBCUTANEOUS7.5 %w/vExact identifier — unii candidate
14 equally ranked IID candidates
HYDROCHLORIC ACIDHYDROCHLORIC ACIDQTT17582CBSOLUTION/ DROPS / AURICULAR (OTIC)ADJ PHExact identifier — unii candidate
148 equally ranked IID candidates
HYDROCHLORIC ACIDHYDROCHLORIC ACIDQTT17582CBSOLUTION, CONCENTRATE / INTRAVENOUSADJ PHExact identifier — unii candidate
148 equally ranked IID candidates
MANNITOLMANNITOL3OWL53L36ATABLET, FOR SUSPENSION / ORAL7621 mgExact identifier — unii candidate
65 equally ranked IID candidates
HYDROCHLORIC ACIDHYDROCHLORIC ACIDQTT17582CBINJECTION, SUSPENSION, LIPOSOMAL / INTRAVENOUSADJ PHExact identifier — unii candidate
148 equally ranked IID candidates
HYDROCHLORIC ACIDHYDROCHLORIC ACIDQTT17582CBINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAMUSCULARADJ PHExact identifier — unii candidate
148 equally ranked IID candidates
HYDROCHLORIC ACIDHYDROCHLORIC ACIDQTT17582CBINJECTION, SUSPENSION / INTRAVITREALADJ PHExact identifier — unii candidate
148 equally ranked IID candidates
HYDROCHLORIC ACIDHYDROCHLORIC ACIDQTT17582CBINJECTION, SOLUTION / INTRAVESICAL157 mgExact identifier — unii candidate
148 equally ranked IID candidates
MANNITOLMANNITOL3OWL53L36ASUSPENSION/ DROPS / TOPICAL0.3 %w/vExact identifier — unii candidate
65 equally ranked IID candidates
MANNITOLMANNITOL3OWL53L36APOWDER, FOR SUSPENSION / ORAL7093 mgExact identifier — unii candidate
65 equally ranked IID candidates
MANNITOLMANNITOL3OWL53L36AINJECTION, SOLUTION / SUBMUCOSAL2.94 %w/vExact identifier — unii candidate
65 equally ranked IID candidates
MANNITOLMANNITOL3OWL53L36ACAPSULE, COATED, EXTENDED RELEASE / ORALNAExact identifier — unii candidate
65 equally ranked IID candidates
ANHYDROUS DEXTROSEANHYDROUS DEXTROSE5SL0G7R0OKINJECTION, POWDER, FOR SOLUTION / INTRAMUSCULAR3.9 %w/vExact identifier — unii candidate
14 equally ranked IID candidates
MANNITOLMANNITOL3OWL53L36AGRANULE, FOR SUSPENSION / ORAL6000 mgExact identifier — unii candidate
65 equally ranked IID candidates
HYDROCHLORIC ACIDHYDROCHLORIC ACIDQTT17582CBINJECTION, SUSPENSION / INTRAVENOUSADJ PHExact identifier — unii candidate
148 equally ranked IID candidates
HYDROCHLORIC ACIDHYDROCHLORIC ACIDQTT17582CBSOLUTION / URETERALADJ PHExact identifier — unii candidate
148 equally ranked IID candidates
HYDROCHLORIC ACIDHYDROCHLORIC ACIDQTT17582CBPOWDER / INTRAVENOUSADJ PHExact identifier — unii candidate
148 equally ranked IID candidates
MANNITOLMANNITOL3OWL53L36ATABLET, CHEWABLE / ORAL3726 mgExact identifier — unii candidate
65 equally ranked IID candidates
MANNITOLMANNITOL3OWL53L36ASOLUTION / INTRAVENOUS15400 mgExact identifier — unii candidate
65 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHINJECTION, EMULSION / INTRAMUSCULAR225 mgExact identifier — unii candidate
50 equally ranked IID candidates
HYDROCHLORIC ACIDHYDROCHLORIC ACIDQTT17582CBSOLUTION / TOPICALADJ PHExact identifier — unii candidate
148 equally ranked IID candidates
HYDROCHLORIC ACIDHYDROCHLORIC ACIDQTT17582CBINJECTION / SOFT TISSUEADJ PHExact identifier — unii candidate
148 equally ranked IID candidates
MANNITOLMANNITOL3OWL53L36ASOLUTION / SUBCUTANEOUS4.54 %w/vExact identifier — unii candidate
65 equally ranked IID candidates
HYDROCHLORIC ACIDHYDROCHLORIC ACIDQTT17582CBINJECTION, POWDER, FOR SOLUTION / INTRADERMALADJ PHExact identifier — unii candidate
148 equally ranked IID candidates
HYDROCHLORIC ACIDHYDROCHLORIC ACIDQTT17582CBINJECTION / INTRALESIONALADJ PHExact identifier — unii candidate
148 equally ranked IID candidates
HYDROCHLORIC ACIDHYDROCHLORIC ACIDQTT17582CBCONCENTRATE / ORAL2.17 mg/1mlExact identifier — unii candidate
148 equally ranked IID candidates
MANNITOLMANNITOL3OWL53L36ACAPSULE, EXTENDED RELEASE / ORAL160 mgExact identifier — unii candidate
65 equally ranked IID candidates
MANNITOLMANNITOL3OWL53L36AINJECTION, POWDER, FOR SOLUTION / INTRAVENOUS980.4 mgExact identifier — unii candidate
65 equally ranked IID candidates
HYDROCHLORIC ACIDHYDROCHLORIC ACIDQTT17582CBSHAMPOO / TOPICAL104 mgExact identifier — unii candidate
148 equally ranked IID candidates
HYDROCHLORIC ACIDHYDROCHLORIC ACIDQTT17582CBSUSPENSION / AURICULAR (OTIC)0.04 %w/vExact identifier — unii candidate
148 equally ranked IID candidates
MANNITOLMANNITOL3OWL53L36AINJECTION / INTRAVENOUS15200 mgExact identifier — unii candidate
65 equally ranked IID candidates
HYDROCHLORIC ACIDHYDROCHLORIC ACIDQTT17582CBLIQUID / INTRAMUSCULARADJ PHExact identifier — unii candidate
148 equally ranked IID candidates
MANNITOLMANNITOL3OWL53L36AINJECTION, SUSPENSION / INTRAVENOUS2.5 %w/vExact identifier — unii candidate
65 equally ranked IID candidates
MANNITOLMANNITOL3OWL53L36ALOZENGE / ORAL20546 mgExact identifier — unii candidate
65 equally ranked IID candidates
HYDROCHLORIC ACIDHYDROCHLORIC ACIDQTT17582CBSUSPENSION/ DROPS / AURICULAR (OTIC)ADJ PHExact identifier — unii candidate
148 equally ranked IID candidates
MANNITOLMANNITOL3OWL53L36ASUSPENSION / OPHTHALMIC9 mgExact identifier — unii candidate
65 equally ranked IID candidates
HYDROCHLORIC ACIDHYDROCHLORIC ACIDQTT17582CBLOTION / TOPICALADJ PHExact identifier — unii candidate
148 equally ranked IID candidates
MANNITOLMANNITOL3OWL53L36AGUM, CHEWING / BUCCAL891 mgExact identifier — unii candidate
65 equally ranked IID candidates
HYDROCHLORIC ACIDHYDROCHLORIC ACIDQTT17582CBINJECTION / INTRABURSALADJ PHExact identifier — unii candidate
148 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHSUSPENSION / TOPICAL1 %w/wExact identifier — unii candidate
50 equally ranked IID candidates
HYDROCHLORIC ACIDHYDROCHLORIC ACIDQTT17582CBPOWDER, FOR SUSPENSION / ORAL125 mgExact identifier — unii candidate
148 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHINJECTION / INTRAVENOUS1620 mgExact identifier — unii candidate
50 equally ranked IID candidates
HYDROCHLORIC ACIDHYDROCHLORIC ACIDQTT17582CBINJECTION, SOLUTION / INTRAVASCULARADJ PHExact identifier — unii candidate
148 equally ranked IID candidates
HYDROCHLORIC ACIDHYDROCHLORIC ACIDQTT17582CBINJECTION, SOLUTION / INTRA-ARTERIALADJ PHExact identifier — unii candidate
148 equally ranked IID candidates
HYDROCHLORIC ACIDHYDROCHLORIC ACIDQTT17582CBINJECTION / PARENTERALADJ PHExact identifier — unii candidate
148 equally ranked IID candidates
HYDROCHLORIC ACIDHYDROCHLORIC ACIDQTT17582CBINJECTION, SUSPENSION / INTRALESIONALADJ PHExact identifier — unii candidate
148 equally ranked IID candidates
HYDROCHLORIC ACIDHYDROCHLORIC ACIDQTT17582CBAEROSOL, METERED / RESPIRATORY (INHALATION)0.7 %w/wExact identifier — unii candidate
148 equally ranked IID candidates
HYDROCHLORIC ACIDHYDROCHLORIC ACIDQTT17582CBDROPS / NASAL10 mlExact identifier — unii candidate
148 equally ranked IID candidates
MANNITOLMANNITOL3OWL53L36ASOLUTION / OPHTHALMIC4.7 %w/vExact identifier — unii candidate
65 equally ranked IID candidates
HYDROCHLORIC ACIDHYDROCHLORIC ACIDQTT17582CBINJECTION / INTRACARDIACADJ PHExact identifier — unii candidate
148 equally ranked IID candidates
ANHYDROUS DEXTROSEANHYDROUS DEXTROSE5SL0G7R0OKINJECTION / INTRAVENOUS36000 mgExact identifier — unii candidate
14 equally ranked IID candidates
HYDROCHLORIC ACIDHYDROCHLORIC ACIDQTT17582CBGEL / TOPICAL10 mgExact identifier — unii candidate
148 equally ranked IID candidates
HYDROCHLORIC ACIDHYDROCHLORIC ACIDQTT17582CBINJECTABLE, LIPOSOMAL / INTRAVENOUSADJ PHExact identifier — unii candidate
148 equally ranked IID candidates
HYDROCHLORIC ACIDHYDROCHLORIC ACIDQTT17582CBSOLUTION / NASAL91.7 mg/100mlExact identifier — unii candidate
148 equally ranked IID candidates
HYDROCHLORIC ACIDHYDROCHLORIC ACIDQTT17582CBINJECTION / INTRAVITREALADJ PHExact identifier — unii candidate
148 equally ranked IID candidates
HYDROCHLORIC ACIDHYDROCHLORIC ACIDQTT17582CBSOLUTION / IRRIGATIONADJ PHExact identifier — unii candidate
148 equally ranked IID candidates
MANNITOLMANNITOL3OWL53L36ATABLET, FILM COATED, EXTENDED RELEASE / ORAL543 mgExact identifier — unii candidate
65 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHSUSPENSION / ORAL100 mgExact identifier — unii candidate
50 equally ranked IID candidates
HYDROCHLORIC ACIDHYDROCHLORIC ACIDQTT17582CBSOLUTION / INTRAVASCULARADJ PHExact identifier — unii candidate
148 equally ranked IID candidates
HYDROCHLORIC ACIDHYDROCHLORIC ACIDQTT17582CBEMULSION / TOPICALADJ PHExact identifier — unii candidate
148 equally ranked IID candidates

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 2 · 36 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
buprenorphine hydrochlorideBUPRENORPHINE HYDROCHLORIDEAdvagen Pharma Ltd699638dd-3a53-445f-a545-d0e6eabfe1c92026-07-17Warnings, Adverse reactionsName fallback
generic name: BUPRENORPHINE HYDROCHLORIDE
BuprenorphineBUPRENORPHINEREMEDYREPACK INC.aa86a438-1ebf-4c08-bf27-38f1e81efb3a2026-07-07Warnings, Adverse reactionsName fallback
brand name: Buprenorphine
buprenorphine hydrochlorideBUPRENORPHINE HYDROCHLORIDEREMEDYREPACK INC.11686845-f5fd-4e96-8a4f-9b132bf488402026-07-07Warnings, Adverse reactionsName fallback
generic name: BUPRENORPHINE HYDROCHLORIDE
BUPRENORPHINEBUPRENORPHINEUnit Dose Solutions, Inc.5578cd5c-c860-6e8a-e063-6394a90a56c72026-06-30Warnings, Adverse reactionsName fallback
brand name: BUPRENORPHINE
BUPRENORPHINEBUPRENORPHINEBryant Ranch Prepackaa132031-9d12-45b4-81e0-4a58776613792026-06-29Warnings, Adverse reactionsName fallback
brand name: BUPRENORPHINE
BuprenorphineBUPRENORPHINEBryant Ranch Prepack655e3e52-03be-496c-978a-5cffc74b2ae42026-06-29Warnings, Adverse reactionsName fallback
brand name: Buprenorphine
BUPRENORPHINEBUPRENORPHINEUnit Dose Solutions, Inc.5479b218-a388-2c3c-e063-6294a90a0e852026-06-17Warnings, Adverse reactionsName fallback
brand name: BUPRENORPHINE
BUPRENORPHINEBUPRENORPHINEBryant Ranch Prepack966adb01-71b4-4e0b-bbc6-b83da9987aa22026-06-16Warnings, Adverse reactionsName fallback
brand name: BUPRENORPHINE
BuprenorphineBUPRENORPHINEMajor Pharmaceuticalsdba586f9-e3f2-4b9c-849b-907c81a5a0ef2026-06-16Warnings, Adverse reactionsName fallback
brand name: Buprenorphine
BUPRENORPHINEBUPRENORPHINEBryant Ranch Prepackbc5a7137-9e8f-438e-84d9-bdbf1db129982026-06-03Warnings, Adverse reactionsName fallback
brand name: BUPRENORPHINE
BuprenorphineBUPRENORPHINERhodes Pharmaceuticals LLC2738feae-316e-426f-971c-5f142ac01b602026-05-29Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Buprenorphine
BuprenorphineBUPRENORPHINEActavis Pharma, Inc.03819118-86f6-4329-adaf-4599e7b71f462026-05-25Warnings, Adverse reactionsName fallback
brand name: Buprenorphine
BuprenorphineBUPRENORPHINETeva Pharmaceuticals USA, Inc.36995ce3-b515-447b-baa9-aa14f84060d82026-05-12Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Buprenorphine
BUPRENORPHINEBUPRENORPHINERhodes Pharmaceuticals LLCda90618a-5621-4b15-bc48-9dcc631418de2026-05-04Warnings, Adverse reactionsName fallback
brand name: BUPRENORPHINE
BuprenorphineBUPRENORPHINEINGENUS PHARMACEUTICALS, LLC186e3be6-8bc0-4bb9-96f5-429d53632f452026-04-28Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Buprenorphine
BuprenorphineBUPRENORPHINEAveva Drug Delivery Systems Inc.1aae9b13-7431-42ef-8558-14a2325820e62026-04-28Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Buprenorphine
BUPRENORPHINEBUPRENORPHINEBryant Ranch Prepackcd0a90c6-32cc-4114-8573-86ac85503bdf2026-04-03Warnings, Adverse reactionsName fallback
brand name: BUPRENORPHINE
buprenorphine hydrochlorideBUPRENORPHINE HYDROCHLORIDEPAI Holdings, LLC dba PAI Pharma442831cf-9636-433a-9a12-e9a8cd31f72a2026-02-28Warnings, Adverse reactionsName fallback
generic name: BUPRENORPHINE HYDROCHLORIDE
BuprenorphineBUPRENORPHINESun Pharmaceutical Industries, Inc.9fd1f18f-0b0f-4059-b603-19ecbf0ed63a2026-02-11Warnings, Adverse reactionsName fallback
brand name: Buprenorphine
BUPRENORPHINEBUPRENORPHINEA-S Medication Solutionsbfb02ea5-22f2-432e-afc8-f1dbe2ea06142026-02-06Warnings, Adverse reactionsName fallback
brand name: BUPRENORPHINE

Reported adverse events (FAERS/openFDA)#

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