FDA.reportPublic FDA data

NDC 13985-036 - PenOne Pro

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
13985-036
Package NDCs from labels
13985-036-02, 13985-036-04, 13985-036-05
Manufacturer
MWI Veterinary Supply Co | Norbrook Laboratories Limited
Effective date
2023-06-01
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
PenOne Pro - MWI Veterinary Supply Co | Norbrook Laboratories LimitedMWI Veterinary Supply Co | Norbrook Laboratories Limited2023-06-01PRESCRIPTION ANIMAL DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
13985-036-02PenOne Pro100 mL in 1 VIAL, GLASSINJECTION, SUSPENSION1004
13985-036-04PenOne Pro250 mL in 1 VIAL, GLASSINJECTION, SUSPENSION2504
13985-036-05PenOne Pro500 mL in 1 VIAL, GLASSINJECTION, SUSPENSION5004

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
13985-036PENONE PRO (PENICILLIN G PROCAINE) INJECTION, SUSPENSION [MWI VETERINARY SUPPLY CO]43 package rows20230609_4049a09f-422f-4220-99ef-8dd6b846945b.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
penicillin G procaineACTIVE INGREDIENT17R794ESYNPENONE PRO (PENICILLIN G PROCAINE) INJECTION, SUSPENSION [MWI/VETONE]1
penicillin GACTIVE MOIETYQ42T66VG0CPENONE PRO (PENICILLIN G PROCAINE) INJECTION, SUSPENSION [MWI/VETONE]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 23 of 26 · 504 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
K-Phos No. 2POTASSIUM PHOSPHATE, MONOBASIC AND SODIUM PHOSPHATE, MONOBASIC, ANHYDROUSBeach Products, Inc.9f446400-c403-4971-879e-1341f7f7d9da2023-02-23Adverse reactionsExact identifier
unii: 4J9FJ0HL51
K Phos OriginalPOTASSIUM PHOSPHATE, MONOBASICBeach Products, Inc.04557ab3-6d21-49b4-b849-744c75b8a6302023-02-23Adverse reactionsExact identifier
unii: 4J9FJ0HL51
K Phos NeutralSODIUM PHOSPHATE, DIBASIC, ANHYDROUS, POTASSIUM PHOSPHATE, MONOBASIC, AND SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATEBeach Products, Inc.83376725-ee0f-40ad-bd90-31a61b9445cf2023-02-23Adverse reactionsExact identifier
unii: 4J9FJ0HL51
Kali phosphoricumDIBASIC POTASSIUM PHOSPHATEBoiron860a5c8e-6d7b-e64d-e053-2991aa0af8022023-01-23Exact identifier
unii: CI71S98N1Z
RehydrateAVENA SATIVA, EQUISETUM HYEMALE, HYPERICUM PERFORATUM, ULMUS FULVA, GLYCYRRHIZA GLABRA, SILICEA, PUERARIA LOBATA, CARLSBAD AQUA, ADENOSINUM TRIPHOSPHORICUM DINATRUM, GERMANIUM SESQUIOXIDE, HYDROGEN, OXYGEN, WIESBADENParaDocs All Natural, Inc.648fab10-c46b-420f-a42c-6642009d83fb2023-01-10WarningsExact identifier
unii: 059QF0KO0R
Kali phosphoricumDIBASIC POTASSIUM PHOSPHATEBoiron860aa384-8552-7a57-e053-2991aa0a43aa2023-01-06Exact identifier
unii: CI71S98N1Z
SleepHYOSCYAMUS NIGER, STRYCHNOS IGNATII SEED, AND POTASSIUM PHOSPHATE, DIBASICHyland's Inc.8ad9775f-367c-45c9-890d-69a3734965f12022-12-14WarningsExact identifier
unii: CI71S98N1Z
Kali PhosDIBASIC POTASSIUM PHOSPHATEHylands Inc.d398ba78-c986-9f9a-e053-2995a90ace532022-12-12WarningsExact identifier
unii: CI71S98N1Z
CALMS FORTEAVENA SATIVA FLOWERING TOP, TRIBASIC CALCIUM PHOSPHATE, MATRICARIA RECUTITA, FERROSOFERRIC PHOSPHATE, HOPS, POTASSIUM PHOSPHATE, DIBASIC, MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE, SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE, AND PASSIFLORA INCARNATA FLOWERHyland's Inc.f48a35d4-aa0c-48b1-a2ad-a614ea2894e82022-12-07WarningsExact identifier
unii: CI71S98N1Z
Refresh Digital PFCARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN AND POLYSORBATE 80Allergan, Inc.97e83e68-6374-4df4-93f6-d707fc32748d2022-11-28WarningsExact identifier
unii: 6OZP39ZG8H
unii: K679OBS311
Refresh DigitalCARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN, POLYSORBATE 80Allergan, Inc.b2bd34d4-fab9-4f4b-9be2-5d30b55f5b812022-11-28WarningsExact identifier
unii: 6OZP39ZG8H
unii: K679OBS311
Sterile WaterWATERFresenius Kabi USA, LLCb45e9f1d-9c48-4b46-8541-d846b89540df2022-10-26Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Kali PhosphoricumKALI PHOSPHORICUMHahnemann Laboratories, INC.eb6ac6ad-4677-1072-e053-2995a90a02e92022-10-19Exact identifier
unii: CI71S98N1Z
Eye washPURIFIED WATERMcKessonbd089fde-24ba-4de5-e053-2995a90a39bb2022-10-18WarningsExact identifier
unii: 059QF0KO0R
Bach Original Flower Remedies Rock WaterWATERNelson Bach USA Limitedea242559-1618-3354-e053-2a95a90a1a952022-10-03WarningsExact identifier
unii: 059QF0KO0R
REFRESH OPTIVECARBOXYMETHYLCELLULOSE SODIUM AND GLYCERINAllergan, Inc.7f8d88af-fd3b-4138-af61-f24c59ccebd72022-09-23WarningsExact identifier
unii: K679OBS311
Sterile WaterWATERMedical Purchasing Solutions, LLCe90b47e3-9636-b9ee-e053-2a95a90ad48c2022-09-19Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
REFRESH OPTIVE AdvancedCARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN, POLYSORBATE 80Allergan, Inc.ebd0839e-2e1d-4e0e-986c-19f1f5c763582022-09-15WarningsExact identifier
unii: 6OZP39ZG8H
unii: K679OBS311
REFRESH OPTIVE AdvancedCARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN, AND POLYSORBATE 80Allergan, Inc.aaa943e4-7c38-4c5a-b7c0-5a656d8cafc02022-09-01WarningsExact identifier
unii: 6OZP39ZG8H
unii: K679OBS311
REFRESH TEARSCARBOXYMETHYLCELLULOSE SODIUMAllergan, Inc.329d1fe0-4432-4565-b7b1-65666bd865262022-06-30WarningsExact identifier
unii: K679OBS311

Reported adverse events (FAERS/openFDA)#

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