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 6 of 15 · 289 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
pH Neutral Emergency EyewashWATERINNOVATIVE SAFETY SUPPLY INC.29a1bd1e-d0dd-478f-e063-6394a90ab0aa2026-01-08WarningsExact identifier
unii: 059QF0KO0R
Cell Energy Performance Drops 2048CELL ENERGY PERFORMANCE DROPSProfessional Complementary Health Formulas8701ea61-5d5f-466b-8d2c-f808e7b4d8fe2026-01-08WarningsExact identifier
unii: 5SL0G7R0OK
Abdominal Pain Drops 2051ABDOMINAL PAIN DROPSProfessional Complementary Health Formulasf1b1dde6-bb37-4774-a58c-b4f648f9c2b52026-01-08WarningsExact identifier
unii: QTT17582CB
BELBUCABUPRENORPHINE HYDROCHLORIDEBioDelivery Sciences International Incbc2b7a3d-72cf-497c-95b0-ba2b71f63c642026-01-02Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 56W8MW3EN1
Buprenorphine and Naloxone Sublingual FilmBUPRENORPHINE AND NALOXONEAlvogen Inc.4210afeb-474c-d842-d68e-af7e0021851a2026-01-01Warnings, Adverse reactionsExact identifier
unii: 56W8MW3EN1
Eye CleanEYE WASHHART Health41f53e2e-c2bc-4bf1-a541-3bcb2cf630022025-12-31WarningsExact identifier
unii: 059QF0KO0R
Buprenorphine HydrochlorideBUPRENORPHINE HYDROCHLORIDEHospira, Inc.23aa1bb3-cecf-4e62-29bb-48488bb66fc32025-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA074137
ndc (package): 0409-2012-32
ndc (package): 0409-2012-03
ndc (product): 0409-2012
ndc11 (package): 00409201203
rxcui: 1655032
spl id: 37d2deb6-c54a-42bb-ad76-4873a59da562
spl set id: 23aa1bb3-cecf-4e62-29bb-48488bb66fc3
unii: 56W8MW3EN1
teeth and gumsCALC FLUORICA, CALC PHOS, FERRUM PHOS, KALI PHOS, MAG PHOS, MALUS PUMILA, FLOS, ROCK WATER, ULEX EUROPAEUS, FLOSSiddha Flower Essences LLC926c79d5-d270-4c0d-aca9-b58571c24f3a2025-12-31WarningsExact identifier
unii: 059QF0KO0R
lung and sinusCALC PHOS, FERRUM PHOS, GENTIANELLA AMARELLA, FLOS, KALI MUR, KALI PHOS, KALI SULPH, ROCK WATER, ROSE CANINA, FLOSSiddha Flower Essences LLC9f7c949f-21bc-473c-ab8d-24837893fccc2025-12-31WarningsExact identifier
unii: 059QF0KO0R
Quality Choice Eye WashWATERChain Drug Marketing Assoc., Inc.1fb8a109-351b-7039-e063-6394a90a73112025-12-30WarningsExact identifier
unii: 059QF0KO0R
Rite Aid Eye WashPURIFIED WATERRite Aid28a18e04-d735-a511-e063-6394a90af6bb2025-12-30WarningsExact identifier
unii: 059QF0KO0R
OCUFRESHWATEROptics Laboratory Inc.b8e477a9-66b9-496b-92fb-3d4bbd7b36b52025-12-29WarningsExact identifier
unii: 059QF0KO0R
Kollourion Eyesalve EyewashPURIFIED WATER 98.3%Miracle Eye Pharmaceuticalsb56d2ab9-169b-b490-e053-2a95a90a80b32025-12-28WarningsExact identifier
unii: 059QF0KO0R
Buprenorphine and Naloxone Sublingual FilmBUPRENORPHINE AND NALOXONERedpharm Drug2fd16916-95a9-14b5-e063-6294a90a79fa2025-12-27Warnings, Adverse reactionsExact identifier
unii: 56W8MW3EN1
ZubsolvBUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDEOrexo US, Inc.5f5cfcfe-d52b-49e6-8fe4-550477332dd22025-12-27Warnings, Adverse reactionsExact identifier
unii: 56W8MW3EN1
Buprenorphine HClBUPRENORPHINE HCLRedpharm Drug301eaed5-8499-ad95-e063-6294a90a58f52025-12-23Warnings, Adverse reactionsExact identifier
unii: 56W8MW3EN1
SuboxoneBUPRENORPHINE HYDROCHLORIDE, NALOXONE HYDROCHLORIDEINDIVIOR INC.8a5edcf9-828c-4f97-b671-268ab13a8ecd2025-12-22Warnings, Adverse reactionsExact identifier
unii: 56W8MW3EN1
Buprenorphine HydrochlorideBUPRENORPHINE HYDROCHLORIDEPar Health USA, LLC34767dda-ce52-4f98-a45f-bb5cee0cd5e62025-12-18Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 56W8MW3EN1
Sterile WaterWATERProPharma Distribution386a0a2f-4ff7-f128-e063-6294a90a7d4d2025-12-18Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
HemorrhoidAESCULUS HIPP, HAMAMELIS, ALOE, CALC PHOS, CARBO AN, CARBO VEG, LACHESIS, LYCOPODIUM, MURIATICUM AC, NITRICUM AC, NUX VOM, PAEONIA, RATANHIA, SEPIA, SULPHURNatural Creations, Incdb1b3aef-ba92-417c-b6f6-58e950ed42142025-12-16WarningsExact identifier
unii: QTT17582CB

Reported adverse events (FAERS/openFDA)#

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