FDA.reportPublic FDA data

NDC 70022-004 - 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
70022-004
Package NDCs from labels
70022-004-10
Manufacturer
PAYLESS COMPOUNDERS, LLC
Effective date
2024-12-11
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
buprenorphine - PAYLESS COMPOUNDERS, LLCPAYLESS COMPOUNDERS, LLC2024-12-11ANIMAL COMPOUNDED DRUG LABEL
buprenorphine - PAYLESS COMPOUNDERS, LLCPAYLESS COMPOUNDERS, LLC2015-10-21ANIMAL COMPOUNDED DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70022-004-10buprenorphine10 mL in 1 VIAL, MULTI-DOSESOLUTION1010
70022-004-10buprenorphine10 mL in 1 VIAL, MULTI-DOSESOLUTION102

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70022-004BUPRENORPHINE INJECTION, SOLUTION BUPRENORPHINE SOLUTION [PAYLESS COMPOUNDERS, LLC]101 package rows20241213_a1c1f498-e101-467f-b81c-1451c44e7a01.zip
70022-004BUPRENORPHINE SOLUTION [PAYLESS COMPOUNDERS, LLC]21 package rows20151022_c385095b-152a-45fd-8c49-3e44493e9a00.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BUPRENORPHINE HYDROCHLORIDEACTIVE INGREDIENT56W8MW3EN1BUPRENORPHINE SOLUTION [PAYLESS COMPOUNDERS, LLC]2
BUPRENORPHINEACTIVE MOIETY40D3SCR4GZBUPRENORPHINE SOLUTION [PAYLESS COMPOUNDERS, LLC]2
ANHYDROUS DEXTROSEINACTIVE INGREDIENT5SL0G7R0OKBUPRENORPHINE SOLUTION [PAYLESS COMPOUNDERS, LLC]2
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBHBUPRENORPHINE SOLUTION [PAYLESS COMPOUNDERS, LLC]2
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBBUPRENORPHINE SOLUTION [PAYLESS COMPOUNDERS, LLC]2
MANNITOLINACTIVE INGREDIENT3OWL53L36ABUPRENORPHINE SOLUTION [PAYLESS COMPOUNDERS, LLC]2
WATERINACTIVE INGREDIENT059QF0KO0RBUPRENORPHINE SOLUTION [PAYLESS COMPOUNDERS, LLC]2
BUPRENORPHINE HYDROCHLORIDEACTIVE INGREDIENT56W8MW3EN1BUPRENORPHINE SOLUTION [PAYLESS COMPOUNDERS, LLC]1
BUPRENORPHINEACTIVE MOIETY40D3SCR4GZBUPRENORPHINE SOLUTION [PAYLESS COMPOUNDERS, LLC]1
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLBUPRENORPHINE SOLUTION [PAYLESS COMPOUNDERS, LLC]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TBUPRENORPHINE SOLUTION [PAYLESS COMPOUNDERS, LLC]1
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHBUPRENORPHINE SOLUTION [PAYLESS COMPOUNDERS, LLC]1
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUBUPRENORPHINE SOLUTION [PAYLESS COMPOUNDERS, LLC]1
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRBUPRENORPHINE SOLUTION [PAYLESS COMPOUNDERS, LLC]1
SUCROSEINACTIVE INGREDIENTC151H8M554BUPRENORPHINE SOLUTION [PAYLESS COMPOUNDERS, LLC]1
WATERINACTIVE INGREDIENT059QF0KO0RBUPRENORPHINE SOLUTION [PAYLESS COMPOUNDERS, LLC]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 13 of 26 · 507 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Buprenorphine HClBUPRENORPHINE HCLBryant Ranch Prepackd5a8c41e-413e-4d48-9739-d158e5681dd02025-03-28Warnings, Adverse reactionsExact identifier
unii: 56W8MW3EN1
Buprenorphine HydrochlorideBUPRENORPHINE HYDROCHLORIDEHikma Pharmaceuticals USA Inc.adc1167e-910e-4d7b-abdc-751d3df0c3dc2025-03-13Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 238129
unii: 56W8MW3EN1
AddiclenzASPARTAME, BENZALKONIUM CHLORIDE, FORMALINUM, METHYLENE CHLORIDE, METHYLPARABEN, PROPYLPARABEN, SODIUM BENZOATE, SODIUM CITRATE, TITANIUM DIOXIDE, ZINCUM OXYDATUM, ARSENICUM ALBUM, BETA VULGARIS, BISPHENOL A, BOLDO, CHELIDONIUM MAJUS, COBALTUM METALLICUM, CUPRUM METALLICUM, GLYPHOSATE, IODIUM, LYCOPODIUM CLAVATUM, PETROSELINUM SATIVUM, PHOSPHORICUM ACIDUM, SELENIUM METALLICUM, TARAXACUM OFFICINALE, ZINCUM METALLICUMDeseret Biologicals, Inc.25036c26-1c21-4e5a-b4db-b8e1774583412025-03-11WarningsExact identifier
unii: OJ245FE5EU
unii: 1Q73Q2JULR
unii: Z8IX2SC1OH
unii: A2I8C7HI9T
Bestmade Natural Products Field of Flowers FormulaAESCULUS CAR, AESCULUS HIP, AGRIMONIA EUP, BROMUS RAM, CALLUNA VULG, CARPINUS BET, CASTANEA SAT, CENTAURIUM UMB, CERATOSTIGMA WILLM, CICHORIUM INT, CLEMATIS VIT, FAGUS SYLV, GENTIANELLA AMARELLA, HELIANTHEMUM NUMMULARIUM, ILEX AQUIFOLIUM, IMPATIENS GLAND, LARIX DECIDUA, LONICERA CAPRIFOLIUM, MALUS, MIMULUS GUT, OLEA EUROP, ORNITHOGALUM UMB, PINUS SYL, POPULUS TREM, PRUNUS CERA, QUERCUS ROB, ROCK WATER, ROSA CAN, SALIX VIT, SCLERANTHUS ANNNUS, SINAPIS ARV, ULEX EURO, ULMUS PROC, VERBENA, VITIS VINBestmade Natural Products2fbf9b7c-e54f-589d-e063-6394a90a14a72025-03-07WarningsExact identifier
unii: 059QF0KO0R
AlcostatTARAXACUM OFFICINALE, AVENA SATIVA, PASSIFLORA INCARNATA, AURUM METALLICUM, CAPSICUM ANNUUM, CHELIDONIUM MAJUS, LACHESIS MUTUS, LYCOPODIUM CLAVATUM, NOX VOMICA, QUERCUS GLANDIUM SPIRITUS, SULPHURICUM ACIDUM, ETHYLICUM, CARCINOSIN, SACCHARUM OFFICINALEEnergique, Inc.77daea02-3c32-4ba3-a7a8-af79b13ddc062025-02-27WarningsExact identifier
unii: C151H8M554
AeroWash EyewashEYEWASH SOLUTIONAero Healthcare US LLCa477de08-4301-0ee5-e053-2995a90af79d2025-02-26WarningsExact identifier
unii: 059QF0KO0R
BuprenorphineBUPRENORPHINEClinical Solutions Wholesale, LLC9d976ee7-9509-49da-89fd-48d7e712697b2025-02-17Warnings, Adverse reactionsExact identifier
unii: 56W8MW3EN1
Advanced Eye Relief Eye WashWATER SOLUTIONBausch & Lomb Incorporated9caccce1-4530-441d-bf76-244edeb9dedc2025-02-17WarningsExact identifier
unii: 059QF0KO0R
SODIUM PHENYLACETATE and SODIUM BENZOATESODIUM PHENYLACETATE AND SODIUM BENZOATEOmnivium Pharmaceuticals LLC9067c301-74f9-457a-9b0f-b7e9b06a35082025-02-15Warnings, Adverse reactionsExact identifier
unii: OJ245FE5EU
Buprenorphine HydrochlorideBUPRENORPHINE HYDROCHLORIDESomerset Therapeutics, LLC74e40c51-853b-4e7f-b3cb-a27af29e1cbf2025-02-11Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 238129
unii: 56W8MW3EN1
Eyesaline Eyewash ConcentratePURIFIED WATERHoneywell Safety Products, Inc.2d90c8e8-f479-3535-e063-6394a90af1222025-02-07WarningsExact identifier
unii: 059QF0KO0R
BuprenorphineBUPRENORPHINEClinical Solutions Wholesale, LLC023c7816-21b1-4f85-be36-9e32d5935c192025-02-03Warnings, Adverse reactionsExact identifier
unii: 56W8MW3EN1
Bestmade Natural Products BM62AMMONIUM BENZOICUM, AURUM MUR, CALC ARS, CARDUUS MAR, CROTALUS HORRIDUS, MURIATIC ACID, NUX VOM, PHOSPHORUS, VIPERABestmade Natural Products2ce99cb7-fe9e-5da2-e063-6294a90afc4e2025-01-30WarningsExact identifier
unii: QTT17582CB
Bestmade Natural Products BM63CEANOTHUS, KALI MUR, KALI ARS, OOPHRINUM, SELENIUM, THALLIUM, WEISBADENBestmade Natural Products2cea4552-3700-3da3-e063-6294a90a14b52025-01-30WarningsExact identifier
unii: 059QF0KO0R
Anticoagulant Citrate Dextrose A ACD-AANTICOAGULANT CITRATE DEXTROSE A ACD-AArteriocyte Medical Systems, Inc.b850deac-161f-4bb0-ac7f-bceac2a230c02025-01-23Exact identifier
unii: 1Q73Q2JULR
Anise PyriteANISE PYRITEUriel Pharmacy Inc.a03cdeb0-8347-40cc-8d17-5510d99575c72025-01-22WarningsExact identifier
unii: C151H8M554
ACD ADEXTROSE MONOHYDRATE, SODIUM CITRATE, AND CITRIC ACID MONOHYDRATETerumo BCT Ltd570770de-9b48-4fc1-a1ee-06002ca9504f2025-01-22Exact identifier
unii: 1Q73Q2JULR
Anticoagulant Citrate Dextrose (ACD-A)DEXTROSE MONOHYDRATE, SODIUM CITRATE, UNSPECIFIED FORM, AND CITRIC ACID MONOHYDRATETerumo BCT, Ltd0130d7c8-d067-4528-beb7-166559c33be92025-01-21Warnings, Adverse reactionsExact identifier
unii: 1Q73Q2JULR
Medics Choice Soothing Eye WashPURIFIED WATERKC Pharmaceuticals, Inc.10e49808-161e-f4ec-e063-6294a90a17752025-01-19WarningsExact identifier
unii: 059QF0KO0R
D-114ALUMINUM METALLICUM, AILANTHUS, BAPTISIA TINCTORIA, FRAGARIA VESCA, YOSCYAMUS NIGER, MURIATICUM ACIDDNA Labsf6f7d369-64ef-0ed9-e053-6294a90a40fa2025-01-13WarningsExact identifier
unii: QTT17582CB

Reported adverse events (FAERS/openFDA)#

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