FDA.reportPublic FDA data

NDC 57664-265 - 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
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

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 5 of 5 · 95 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AtenololATENOLOLUnichem Pharmaceuticals (USA), Inc.35d99c43-7305-4a4a-886e-a9bf3ee88fa82024-01-18Warnings, Adverse reactionsExact identifier
rxcui: 197379
rxcui: 197380
rxcui: 197381
AtenololATENOLOLZydus Pharmaceuticals USA Inc.db801706-1362-44c7-92ab-f584f96c7e1c2024-01-11Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197379
rxcui: 197380
rxcui: 197381
AtenololATENOLOLA-S Medication Solutionsd73a475a-c8c9-44a0-89ac-6a2d665c0d242023-12-26Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197380
AtenololATENOLOLA-S Medication Solutionsa0e3b2a5-5ea1-4549-8144-bd059f7966f02023-12-03Warnings, Adverse reactionsExact identifier
rxcui: 197379
AtenololATENOLOLA-S Medication Solutions98471493-56ee-47a4-9120-0975c265361e2023-12-03Warnings, Adverse reactionsExact identifier
rxcui: 197381
AtenololATENOLOLNCS HealthCare of KY, LLC dba Vangard Labsc8cdb347-1767-4595-baff-b50987cd8c3a2023-02-23Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197380
rxcui: 197381
AtenololATENOLOLAphena Pharma Solutions - Tennessee, LLC9aef7a49-d21f-4529-8abf-68bdc343bb6c2022-08-24Warnings, Adverse reactionsExact identifier
rxcui: 197380
AtenololATENOLOLProficient Rx LP0a54656e-60dd-4ffc-b01a-423af19cd6182022-07-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197381
AtenololATENOLOLProficient Rx LP24f1f3f4-bbda-458b-b15f-d942c90534e22022-06-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197380
AtenololATENOLOLProficient Rx LPe115f27a-6a7c-498c-b4a1-2d4c5716af222020-10-01Warnings, Adverse reactionsExact identifier
rxcui: 197381
AtenololATENOLOLBryant Ranch Prepackba0b0221-d4b3-4cb1-9435-53a75fcc4b402020-07-07Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197380
AtenololATENOLOLProficient Rx LPb198b34c-861a-4b52-b4df-8c48b807520a2020-02-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197381
AtenololATENOLOLProficient Rx LPc3a23869-1e3f-40f0-9726-8337005801132019-10-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197380
AtenololATENOLOLAphena Pharma Solutions - Tennessee, LLCb02b4be4-b75c-4153-b402-cf330a0774392017-12-08Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197379
rxcui: 197381
703B8B58-E0F2-9A0B-3443-E5F84ED5BF47f36d4ed3-dcbb-4465-9fa6-1da811f555e62007-07-10Boxed warning, Warnings, Adverse reactionsExact identifier
spl id: 703B8B58-E0F2-9A0B-3443-E5F84ED5BF47
spl set id: f36d4ed3-dcbb-4465-9fa6-1da811f555e6

Reported adverse events (FAERS/openFDA)#

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