FDA.reportPublic FDA data

NDC 83634-102-41 - Penicillin G Potassium

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
83634-102
Requested NDC
83634-102-41
Package NDCs from labels
83634-102-41, 83634-102-20
Manufacturer
Avenacy Inc.
Effective date
2025-02-01
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Penicillin G Potassium for Injection, USPAvenacy Inc.2025-02-01HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83634-102-20Penicillin G Potassium10 in 1 CARTONINJECTION, POWDER, FOR SOLUTION101
83634-102-41Penicillin G Potassium1 in 1 VIALINJECTION, POWDER, FOR SOLUTION11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83634-102PENICILLIN G POTASSIUM INJECTION, POWDER, FOR SOLUTION [AVENACY INC.]1Current NDC, 2 package rows20250201_969a421e-37d8-499e-9e89-67e210bd5d9d.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
83634-102-20EA - Each83634-1029bc392f5-7d4f-4fa9-b9a5-8134d16e0e8312025-05-14
83634-102-41EA - Each83634-1024a0284da-51ef-4af9-af3f-7cdcb3cc3c7b12026-02-05

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 2 of 3 · 44 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sodium Citrate and Citric AcidSODIUM CITRATE AND CITRIC ACIDKesin Pharma Corporation3140f8fe-0644-7561-e063-6394a90a2c282025-04-21Adverse reactionsExact identifier
unii: 1Q73Q2JULR
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: 1Q73Q2JULR
Penicillin G PotassiumPENICILLIN G POTASSIUMAvenacy Inc.969a421e-37d8-499e-9e89-67e210bd5d9d2025-02-01Warnings, Adverse reactionsExact identifier
application number: ANDA065448
ndc (package): 83634-102-41
ndc (package): 83634-102-20
ndc (package): 83634-103-51
ndc (product): 83634-102
ndc (product): 83634-103
ndc11 (package): 83634010241
rxcui: 863538
spl id: 727994cd-436d-4347-a023-5a861abd3264
spl set id: 969a421e-37d8-499e-9e89-67e210bd5d9d
unii: VL775ZTH4C
Penicillin G PotassiumPENICILLIN G POTASSIUMAthenex Pharmaceutical Division, LLC.1442486a-05d6-4dce-8b95-857a30f478c22025-01-28Warnings, Adverse reactionsExact identifier
application number: ANDA065448
rxcui: 863538
unii: VL775ZTH4C
Anticoagulant Citrate Dextrose A ACD-AANTICOAGULANT CITRATE DEXTROSE A ACD-AArteriocyte Medical Systems, Inc.b850deac-161f-4bb0-ac7f-bceac2a230c02025-01-23Exact identifier
unii: 1Q73Q2JULR
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
Sodium Citrate and Citric AcidSODIUM CITRATE AND CITRIC ACID MONOHYDRATEAvPAKfe070e2e-3e72-fb84-e053-6294a90afd882025-01-09Adverse reactionsExact identifier
unii: 1Q73Q2JULR
PfizerpenPENICILLIN G POTASSIUMRoerig2f7ea103-56cc-492f-b862-af45f9aed9802024-12-12Warnings, Adverse reactionsExact identifier
rxcui: 863538
unii: VL775ZTH4C
PfizerpenPENICILLIN G POTASSIUMRoerigd8aaefb6-3f7d-4bc5-b40a-1c58c30543202024-12-10Warnings, Adverse reactionsExact identifier
rxcui: 863538
unii: VL775ZTH4C
Penicillin G PotassiumPENICILLIN G POTASSIUMSagent Pharmaceuticalsfb2f3afe-0072-4383-bad8-9da9e94db4f22024-12-04Warnings, Adverse reactionsExact identifier
application number: ANDA065448
rxcui: 863538
unii: VL775ZTH4C
TRICITRATESPOTASSIUM CITRATE, SODIUM CITRATE, AND CITRIC ACID MONOHYDRATEPAI Holdings, LLC dba PAI Pharma2ecb42a2-82f1-456b-8f1e-02c2d0a7b5ad2024-11-15Warnings, Adverse reactionsExact identifier
unii: 1Q73Q2JULR
Sodium Citrate and Citric AcidSODIUM CITRATE AND CITRIC ACID MONOHYDRATEPharmaceutical Associates, Inc.63201a61-6ac5-41ae-8b2d-ff0d3a8ddfd52024-11-13Adverse reactionsExact identifier
unii: 1Q73Q2JULR
AddiclenzBOLDO, CARDUUS MARIANUS, CHELIDONIUM MAJUS, PETROSELINUM SATIVUM, TARAXACUM OFFICINALE, ARSENICUM ALBUM, BISPHENOL A, COBALTUM METALLICUM, CUPRUM METALLICUM, GLYPHOSATE, IODIUM, LYCOPODIUM CLAVATUM, PHOSPHORICUM ACIDUM, SELENIUM METALLICUM, ZINCUM METALLICUM, ASPARTAME, BENZALKONIUM CHLORIDE, FORMALINUM, METHYLENE CHLORIDE, METHYL PARABEN, PROPYL PARABEN, SODIUM BENZOATE, SODIUM CITRATE, TITANIUM DIOXIDE, ZINCUM OXYDATUMDeseret Biologicals, Inc.8a3b75ca-8fec-4318-8a55-8bde0b82637d2024-10-31WarningsExact identifier
unii: 1Q73Q2JULR
Sodium Citrate and Citric AcidSODIUM CITRATE AND CITRIC ACID MONOHYDRATEAmerican Health Packaging58fa9952-c8ab-4ebb-a073-15cc45f4832a2024-07-16Adverse reactionsExact identifier
unii: 1Q73Q2JULR
Penicillin G PotassiumPENICILLIN G POTASSIUMNorthStar Rx, LLC8732b7ff-2e47-4f99-aadf-81861b431f4f2024-06-28Warnings, Adverse reactionsExact identifier
application number: ANDA065448
rxcui: 863538
unii: VL775ZTH4C
Sodium Citrate and Citric AcidSODIUM CITRATE AND CITRIC ACIDChartwell RX, LLC525136c9-7758-437b-b57b-94b9057868252024-05-31Adverse reactionsExact identifier
unii: 1Q73Q2JULR
Balanced SaltSODIUM CHLORIDE, POTASSIUM CHLORIDE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE, SODIUM ACETATE, AND SODIUM CITRATEB. Braun Medical Inc.74ab8883-0a5f-46b4-8998-9358f6fd4ef42024-03-13Warnings, Adverse reactionsExact identifier
unii: 1Q73Q2JULR
BSSBALANCED SALT SOLUTIONAlcon Laboratories, Inc.4bd4d59c-eb3b-4a5e-9eb7-ae95b0a92bea2024-01-25Warnings, Adverse reactionsExact identifier
unii: 1Q73Q2JULR
BSSBALANCED SALT SOLUTIONAlcon Laboratories, Inc.28488c7b-cf6a-4a03-916f-cc66b3afdc572023-12-14Warnings, Adverse reactionsExact identifier
unii: 1Q73Q2JULR

Reported adverse events (FAERS/openFDA)#

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