FDA.reportPublic FDA data

NDC 0409-2012-03 - Buprenorphine Hydrochloride

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
0409-2012
Requested NDC
0409-2012-03
Package NDCs from labels
0409-2012-03, 0409-2012-32
Manufacturer
Hospira, Inc. | Macfarlan Smith Limited
Effective date
2025-12-31
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Buprenorphine Hydrochloride - Hospira, Inc. | Macfarlan Smith LimitedHospira, Inc. | Macfarlan Smith Limited2025-12-31HUMAN PRESCRIPTION DRUG LABEL
Buprenorphine Hydrochloride - Rebel Distributors CorpRebel Distributors Corp2010-12-10HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0409-2012-03Buprenorphine Hydrochloride1 mL in 1 CARTRIDGEINJECTION, SOLUTION120
0409-2012-32Buprenorphine Hydrochloride10 in 1 CARTONINJECTION, SOLUTION1020

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0409-2012BUPRENORPHINE HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.]19Current NDC, Legacy NDC, 2 package rows20240726_23aa1bb3-cecf-4e62-29bb-48488bb66fc3.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0409-2012-03ML - Milliliter0409-2012cfea3dc4-46db-4825-9a09-f7b80f48554f12017-07-07
0409-2012-32ML - Milliliter0409-20129849ebbb-eecf-4f04-90c7-5bc540c548f912012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BUPRENORPHINE HYDROCHLORIDEACTIVE INGREDIENT56W8MW3EN1BUPRENORPHINE HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.]10
BuprenorphineACTIVE MOIETY40D3SCR4GZBUPRENORPHINE HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.]10
ANHYDROUS DEXTROSEINACTIVE INGREDIENT5SL0G7R0OKBUPRENORPHINE HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.]10
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBBUPRENORPHINE HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.]10
WATERINACTIVE INGREDIENT059QF0KO0RBUPRENORPHINE HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.]10
BUPRENORPHINE HYDROCHLORIDEACTIVE INGREDIENT56W8MW3EN1BUPRENORPHINE HYDROCHLORIDE INJECTION, SOLUTION [REBEL DISTRIBUTORS CORP]1
BuprenorphineACTIVE MOIETY40D3SCR4GZBUPRENORPHINE HYDROCHLORIDE INJECTION, SOLUTION [REBEL DISTRIBUTORS CORP]1
ANHYDROUS DEXTROSEINACTIVE INGREDIENT5SL0G7R0OKBUPRENORPHINE HYDROCHLORIDE INJECTION, SOLUTION [REBEL DISTRIBUTORS CORP]1
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBBUPRENORPHINE HYDROCHLORIDE INJECTION, SOLUTION [REBEL DISTRIBUTORS CORP]1
WATERINACTIVE INGREDIENT059QF0KO0RBUPRENORPHINE HYDROCHLORIDE INJECTION, SOLUTION [REBEL DISTRIBUTORS CORP]1

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 · 290 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
KUGIG ALOE FOAMING INTIMATE WASHINTIMATE CLEANSING FOAMHong Kong KangXing Centennial Management Limited59f4d398-1186-a168-e063-6294a90ab44b2026-08-26WarningsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERREMEDYREPACK INC.5dd5d148-6e23-41de-bff5-551b2aea95982026-08-24Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
buprenorphine hydrochloride and naloxone hydrochloride dihydrateBUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE DIHYDRATEREMEDYREPACK INC.4124c4ad-ef62-4c95-8e57-0d843862ae712026-08-17Warnings, Adverse reactionsExact identifier
unii: 56W8MW3EN1
buprenorphine hydrochloride and naloxone hydrochloride dihydrateBUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE DIHYDRATEREMEDYREPACK INC.43027750-d218-49e5-867f-c941736d20562026-08-17Warnings, Adverse reactionsExact identifier
unii: 56W8MW3EN1
BM BM63 DROPSCEANOTHUS, KALI ARSEN, KALI MUR, SELENIUM, THALLIUM, WIESBADENBM Private Limited59006d82-610a-2e08-e063-6394a90af1ed2026-08-14WarningsExact identifier
unii: 059QF0KO0R
Buprenorphine and Naloxone Sublingual FilmBUPRENORPHINE AND NALOXONERedpharm Drug58d2c995-c0cf-a007-e063-6394a90a3f772026-08-12Warnings, Adverse reactionsExact identifier
unii: 56W8MW3EN1
Sterile WaterWATERCardinal Health 107, LLC48d75a7c-8329-48a8-bea0-a8c144ddf6372026-08-07Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
GarzulysINSULIN ASPART-FSANMeitheal Pharmaceuticals Inc.30c64769-d2f7-4604-ac9e-2a6bc09506c92026-07-31Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
DECONIMO ReconstitutionDECONIMO RECONSTITUTIONImage Amazon LLC57ab9b1c-9a18-3786-e063-6394a90a2c632026-07-28WarningsExact identifier
unii: 059QF0KO0R
buprenorphine and naloxoneBUPRENORPHINE AND NALOXONEHikma Pharmaceuticals USA Inc.713db2c6-0544-4633-b874-cfbeaf93db892026-07-26Warnings, Adverse reactionsExact identifier
unii: 56W8MW3EN1
Sterile WaterWATERCardinal Health 107, LLC9655cd02-82b5-4a75-813b-854b195514812026-07-21Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
buprenorphine hydrochlorideBUPRENORPHINE HYDROCHLORIDEAdvagen Pharma Ltd699638dd-3a53-445f-a545-d0e6eabfe1c92026-07-17Warnings, Adverse reactionsExact identifier
unii: 56W8MW3EN1
Buprenorphine HClBUPRENORPHINE HCLREMEDYREPACK INC.e1aac2bb-cb83-46cb-9a29-502a620106672026-07-17Warnings, Adverse reactionsExact identifier
unii: 56W8MW3EN1
BuprenorphineBUPRENORPHINEREMEDYREPACK INC.aa86a438-1ebf-4c08-bf27-38f1e81efb3a2026-07-07Warnings, Adverse reactionsExact identifier
unii: 56W8MW3EN1
buprenorphine hydrochlorideBUPRENORPHINE HYDROCHLORIDEREMEDYREPACK INC.11686845-f5fd-4e96-8a4f-9b132bf488402026-07-07Warnings, Adverse reactionsExact identifier
unii: 56W8MW3EN1
Dr. Drop NMN Vital Balance (Drop No.1 Cream 90g)NMN (NICOTINAMIDE MONONUCLEOTIDE), ECTOIN (ECTOINE)Reedfresh Co., LTD55d703ca-ff9d-0dbc-e063-6294a90ab6b12026-07-05WarningsExact identifier
unii: 059QF0KO0R
Eyesaline Eyewash ConcentratePURIFIED WATERProtective Industrial Products, Inc.558e5926-9027-d3f6-e063-6294a90ab1212026-07-02WarningsExact identifier
unii: 059QF0KO0R
Fendall 2000 Pure FlowPURIFIED WATERProtective Industrial Products, Inc.55a1d07e-0006-0c75-e063-6394a90a7acc2026-07-02WarningsExact identifier
unii: 059QF0KO0R
Fendall 1000 Pure FlowPURIFIED WATERProtective Industrial Products, Inc.55a2f4da-bb1e-8ead-e063-6394a90af72e2026-07-02WarningsExact identifier
unii: 059QF0KO0R
Sterile Eyesaline EyewashSTERILE EYESALINE EYEWASHProtective Industrial Products, Inc.55a290e8-8310-8be4-e063-6394a90abdce2026-07-02WarningsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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