FDA.reportPublic FDA data

NDC 57664-265-18 - 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
57664-265
Requested NDC
57664-265-18
Package NDCs from labels
57664-265-88, 57664-265-13, 57664-265-18
Manufacturer
CARACO PHARMACEUTICAL LABORATORIES, LTD.
Effective date
2007-07-10
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Atenolol - CARACO PHARMACEUTICAL LABORATORIES, LTD.CARACO PHARMACEUTICAL LABORATORIES, LTD.2007-07-10HUMAN PRESCRIPTION DRUG LABEL
National Council for Prescription Drug Programs indexing - billing unitNational Council for Prescription Drug Programs2013-02-13Indexing - Billing Unit

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57664-265-13Atenolol500 in 1 BOTTLETABLET5001
57664-265-18Atenolol1000 in 1 BOTTLETABLET10001
57664-265-88Atenolol100 in 1 BOTTLETABLET1001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57664-265ATENOLOL (ATENOLOL) TABLET [CARACO PHARMACEUTICAL LABORATORIES, LTD.]13 package rows20070921_f36d4ed3-dcbb-4465-9fa6-1da811f555e6.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
57664-265-18EA - Each57664-2650c053fdb-3d4b-49a6-acd9-1eb2f194892812013-02-13
57664-265-88EA - Each57664-2656b08e501-9a83-4ab8-bb66-b09c8b1e3d2012013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
atenololACTIVE INGREDIENT50VV3VW0TIATENOLOL (ATENOLOL) TABLET [CARACO PHARMACEUTICAL LABORATORIES, LTD.]1
atenololACTIVE MOIETY50VV3VW0TIATENOLOL (ATENOLOL) TABLET [CARACO PHARMACEUTICAL LABORATORIES, LTD.]1
colloidal silicon dioxideINACTIVE INGREDIENTATENOLOL (ATENOLOL) TABLET [CARACO PHARMACEUTICAL LABORATORIES, LTD.]1
corn starchINACTIVE INGREDIENTATENOLOL (ATENOLOL) TABLET [CARACO PHARMACEUTICAL LABORATORIES, LTD.]1
croscarmellose sodiumINACTIVE INGREDIENTATENOLOL (ATENOLOL) TABLET [CARACO PHARMACEUTICAL LABORATORIES, LTD.]1
magnesium stearateINACTIVE INGREDIENT70097M6I30ATENOLOL (ATENOLOL) TABLET [CARACO PHARMACEUTICAL LABORATORIES, LTD.]1
microcrystalline celluloseINACTIVE INGREDIENTATENOLOL (ATENOLOL) TABLET [CARACO PHARMACEUTICAL LABORATORIES, LTD.]1
povidoneINACTIVE INGREDIENTATENOLOL (ATENOLOL) TABLET [CARACO PHARMACEUTICAL LABORATORIES, LTD.]1
sodium lauryl sulfateINACTIVE INGREDIENT368GB5141JATENOLOL (ATENOLOL) TABLET [CARACO PHARMACEUTICAL LABORATORIES, LTD.]1
sodium stearyl fumarateINACTIVE INGREDIENTATENOLOL (ATENOLOL) TABLET [CARACO PHARMACEUTICAL LABORATORIES, LTD.]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 5 · 95 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AtenololATENOLOLREMEDYREPACK INC.897e18f6-3b57-4ef0-85ff-9dfa23521eb92026-09-03Warnings, Adverse reactionsExact identifier
rxcui: 197380
AtenololATENOLOLREMEDYREPACK INC.cdca0ef8-2ac3-4430-a662-f88522f68d8e2026-08-27Warnings, Adverse reactionsExact identifier
rxcui: 197379
AtenololATENOLOLSt. Mary's Medical Park Pharmacy59f418e6-47db-6a71-e063-6294a90a632c2026-08-25Warnings, Adverse reactionsExact identifier
rxcui: 197381
AtenololATENOLOLCardinal Health 107, LLC15c0c2df-f195-45f9-a1e4-1ed2a43c22162026-08-07Warnings, Adverse reactionsExact identifier
rxcui: 197380
rxcui: 197381
AtenololATENOLOLREMEDYREPACK INC.4ca8dd77-cdac-41fe-a742-b1b32551203b2026-07-31Warnings, Adverse reactionsExact identifier
rxcui: 197381
AtenololATENOLOLCardinal Health 107, LLC0fadc652-b075-46ec-ae05-beaf7d91ae132026-07-20Warnings, Adverse reactionsExact identifier
rxcui: 197381
AtenololATENOLOLSafecor Health, LLC35d04cfd-34d4-429c-b990-a6c00137bc772026-07-10Warnings, Adverse reactionsExact identifier
rxcui: 197379
rxcui: 197380
rxcui: 197381
AtenololATENOLOLSt. Mary's Medical Park Pharmacy7f8304a4-93de-774f-e053-2a91aa0aa5b52026-06-20Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197381
AtenololATENOLOLSt Mary's Medical Park Pharmacy78d394b8-8ffb-a846-e053-2991aa0aa58c2026-06-17Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197379
AtenololATENOLOLSt. Mary's Medical Park Pharmacy8501f6c1-8157-4189-e053-2a91aa0ac4ef2026-06-02Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197380
AtenololATENOLOLASCLEMED USA INC.2ee7b7da-303d-4a57-a1eb-25e8923660c02026-05-19Warnings, Adverse reactionsExact identifier
rxcui: 197379
rxcui: 197380
rxcui: 197381
AtenololATENOLOLCoupler LLC5126a70e-632d-e626-e063-6394a90ab7912026-05-06Warnings, Adverse reactionsExact identifier
rxcui: 197379
AtenololATENOLOLCoupler LLC50760735-9305-0bbf-e063-6294a90a5b4c2026-04-27Warnings, Adverse reactionsExact identifier
rxcui: 197381
AtenololATENOLOLCoupler LLC50762eee-e139-4d7f-e063-6294a90a777c2026-04-27Warnings, Adverse reactionsExact identifier
rxcui: 197380
AtenololATENOLOLPreferred Pharmaceuticals Inc.0ad0c7dd-e4e5-4968-9372-7a9bb30073ec2026-04-22Warnings, Adverse reactionsExact identifier
rxcui: 197379
AtenololATENOLOLREMEDYREPACK INC.f5c86a73-70b6-46b2-ad9a-272c8d4673e92026-04-13Warnings, Adverse reactionsExact identifier
rxcui: 197380
AtenololATENOLOLPreferred Pharmaceuticals Inc.5ad1426a-5a74-427b-812d-c7b144c844742026-03-10Warnings, Adverse reactionsExact identifier
rxcui: 197380
AtenololATENOLOLPreferred Pharmaceuticals, Inc.26d3df38-20c6-40e0-a456-da4f10fff6322026-03-10Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197379
AtenololATENOLOLPreferred Pharmaceuticals, Inc.a8d48a47-ccab-4a35-a092-6e562683ade32026-03-10Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197381
AtenololATENOLOLPreferred Pharmaceuticals Inc.82100fc8-5a5a-4d80-8101-72024ee0abef2026-03-09Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197380

Reported adverse events (FAERS/openFDA)#

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