FDA.reportPublic FDA data

NDC 61570-020 - Quibron-T

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
61570-020
Package NDCs from labels
61570-020-01
Manufacturer
Monarch Pharmaceuticals, Inc.
Effective date
2006-11-09
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Quibron-T - Monarch Pharmaceuticals, Inc.Monarch Pharmaceuticals, Inc.2006-11-09Human prescription drug label

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61570-020-01Quibron-T100 in 1 BOTTLETABLET1001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61570-020QUIBRON-T (THEOPHYLLIN, ANHYDROUS) TABLET [MONARCH PHARMACEUTICALS, INC.]11 package rows20061215_6C08B50E-CC9F-4C49-D7AE-F0FDDCB10199.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
theophylline, anhydrousACTIVE INGREDIENT0I55128JYKQUIBRON-T (THEOPHYLLIN, ANHYDROUS) TABLET [MONARCH PHARMACEUTICALS, INC.]1
theophyllineACTIVE MOIETYC137DTR5RGQUIBRON-T (THEOPHYLLIN, ANHYDROUS) TABLET [MONARCH PHARMACEUTICALS, INC.]1
celluloseINACTIVE INGREDIENTQUIBRON-T (THEOPHYLLIN, ANHYDROUS) TABLET [MONARCH PHARMACEUTICALS, INC.]1
hydroxypropyl methylcellulose 2910INACTIVE INGREDIENTQUIBRON-T (THEOPHYLLIN, ANHYDROUS) TABLET [MONARCH PHARMACEUTICALS, INC.]1
lactose monohydrateINACTIVE INGREDIENTQUIBRON-T (THEOPHYLLIN, ANHYDROUS) TABLET [MONARCH PHARMACEUTICALS, INC.]1
magnesium stearateINACTIVE INGREDIENT70097M6I30QUIBRON-T (THEOPHYLLIN, ANHYDROUS) TABLET [MONARCH PHARMACEUTICALS, INC.]1
silicon dioxideINACTIVE INGREDIENTETJ7Z6XBU4QUIBRON-T (THEOPHYLLIN, ANHYDROUS) TABLET [MONARCH PHARMACEUTICALS, INC.]1
sodium starch glycolateINACTIVE INGREDIENTQUIBRON-T (THEOPHYLLIN, ANHYDROUS) TABLET [MONARCH PHARMACEUTICALS, INC.]1
yellow ferric oxideINACTIVE INGREDIENTQUIBRON-T (THEOPHYLLIN, ANHYDROUS) TABLET [MONARCH PHARMACEUTICALS, INC.]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 1 ยท 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
6C08B50E-CC9F-4C49-D7AE-F0FDDCB101996C08B50E-CC9F-4C49-D7AE-F0FDDCB101992006-11-09Warnings, Adverse reactionsExact identifier
spl id: 6C08B50E-CC9F-4C49-D7AE-F0FDDCB10199
spl set id: 6C08B50E-CC9F-4C49-D7AE-F0FDDCB10199

Reported adverse events (FAERS/openFDA)#

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