FDA.reportPublic FDA data

NDC 0591-5778-01 - Atenolol

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
0591-5778
Requested NDC
0591-5778-01
Package NDCs from labels
0591-5778-01
Manufacturer
Rebel Distributors Corp.
Effective date
2009-06-01
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Atenolol Tablets, USPRebel Distributors Corp.2009-06-01HUMAN PRESCRIPTION DRUG LABEL
Atenolol Tablets USP Revised: April 2006 Rx onlyWatson Laboratories, Inc.2007-03-02HUMAN PRESCRIPTION DRUG LABELING
Atenolol Tablets USP Rx onlyWatson Laboratories, Inc.2006-03-08HUMAN PRESCRIPTION DRUG LABELING

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0591-5778-01Atenolol100 in 1 BOTTLETABLET1001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0591-5778ATENOLOL (ATENOLOL) TABLET [WATSON LABORATORIES, INC.]11 package rows20070309_A32ECCC4-16D1-47A5-9E61-261F5D38638C.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AtenololACTIVE INGREDIENT50VV3VW0TIATENOLOL (ATENOLOL) TABLET [WATSON LABORATORIES, INC.]1
ATENOLOLACTIVE INGREDIENT50VV3VW0TIATENOLOL TABLET [REBEL DISTRIBUTORS CORP.]1
AtenololACTIVE INGREDIENT50VV3VW0TIATENOLOL (ATENOLOL) TABLET [WATSON LABORATORIES, INC.]1
AtenololACTIVE MOIETY50VV3VW0TIATENOLOL (ATENOLOL) TABLET [WATSON LABORATORIES, INC.]1
ATENOLOLACTIVE MOIETY50VV3VW0TIATENOLOL TABLET [REBEL DISTRIBUTORS CORP.]1
AtenololACTIVE MOIETY50VV3VW0TIATENOLOL (ATENOLOL) TABLET [WATSON LABORATORIES, INC.]1
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ATENOLOL TABLET [REBEL DISTRIBUTORS CORP.]1
MAGNESIUM CARBONATEINACTIVE INGREDIENT0E53J927NAATENOLOL TABLET [REBEL DISTRIBUTORS CORP.]1
magnesium stearateINACTIVE INGREDIENT70097M6I30ATENOLOL (ATENOLOL) TABLET [WATSON LABORATORIES, INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ATENOLOL TABLET [REBEL DISTRIBUTORS CORP.]1
magnesium stearateINACTIVE INGREDIENT70097M6I30ATENOLOL (ATENOLOL) TABLET [WATSON LABORATORIES, INC.]1
microcrystalline celluloseINACTIVE INGREDIENTATENOLOL (ATENOLOL) TABLET [WATSON LABORATORIES, INC.]1
microcrystalline celluloseINACTIVE INGREDIENTATENOLOL (ATENOLOL) TABLET [WATSON LABORATORIES, INC.]1
povidoneINACTIVE INGREDIENTATENOLOL (ATENOLOL) TABLET [WATSON LABORATORIES, INC.]1
povidoneINACTIVE INGREDIENTATENOLOL (ATENOLOL) TABLET [WATSON LABORATORIES, INC.]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ATENOLOL TABLET [REBEL DISTRIBUTORS CORP.]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JATENOLOL TABLET [REBEL DISTRIBUTORS CORP.]1
sodium starch glycolateINACTIVE INGREDIENTATENOLOL (ATENOLOL) TABLET [WATSON LABORATORIES, INC.]1
sodium starch glycolateINACTIVE INGREDIENTATENOLOL (ATENOLOL) TABLET [WATSON LABORATORIES, INC.]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2ATENOLOL TABLET [REBEL DISTRIBUTORS CORP.]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJATENOLOL TABLET [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 39 of 39 · 762 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
C2C3B3F1-D236-EC09-9934-C3F9BA96E04BA32ECCC4-16D1-47A5-9E61-261F5D38638C2007-03-02Boxed warning, Warnings, Adverse reactionsExact identifier
spl id: C2C3B3F1-D236-EC09-9934-C3F9BA96E04B
spl set id: A32ECCC4-16D1-47A5-9E61-261F5D38638C
D18BCF6D-2F2D-4F70-735B-4CAD05CE9AF4A5C67C7A-0FFD-4C51-BADB-B5109D4D25B62006-03-08Warnings, Adverse reactionsExact identifier
spl id: D18BCF6D-2F2D-4F70-735B-4CAD05CE9AF4
spl set id: A5C67C7A-0FFD-4C51-BADB-B5109D4D25B6

Reported adverse events (FAERS/openFDA)#

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