FDA.reportPublic FDA data

NDC 66304-971 - Clarithromycin Extended Release

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
66304-971
Package NDCs from labels
66304-971-10
Manufacturer
Ranbaxy Pharmaceuticals Inc.
Effective date
2008-08-08
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Clarithromycin Extended Release - Ranbaxy Pharmaceuticals Inc.Ranbaxy Pharmaceuticals Inc.2008-08-08HUMAN PRESCRIPTION DRUG LABELING

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63304-971-05Clarithromycin Extended Release500 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE5001
63304-971-14Clarithromycin Extended Release14 in 1 BOX, UNIT-DOSETABLET, FILM COATED, EXTENDED RE141
63304-971-70Clarithromycin Extended Release70 in 1 BOX, UNIT-DOSETABLET, FILM COATED, EXTENDED RE701
66304-971-10Clarithromycin Extended Release10 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE101

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66304-971CLARITHROMYCIN EXTENDED RELEASE (CLARITHROMYCIN) TABLET, FILM COATED, EXTENDED RELEASE [RANBAXY PHARMACEUTICALS INC.]14 package rows20080908_f21494ed-c5e8-4ddf-b140-ecd68c5c312b.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ClarithromycinACTIVE INGREDIENTH1250JIK0ACLARITHROMYCIN EXTENDED RELEASE (CLARITHROMYCIN) TABLET, FILM COATED, EXTENDED RELEASE [RANBAXY PHARMACEUTICALS INC.]1
ClarithromycinACTIVE MOIETYH1250JIK0ACLARITHROMYCIN EXTENDED RELEASE (CLARITHROMYCIN) TABLET, FILM COATED, EXTENDED RELEASE [RANBAXY PHARMACEUTICALS INC.]1
ammonium hydroxideINACTIVE INGREDIENTCLARITHROMYCIN EXTENDED RELEASE (CLARITHROMYCIN) TABLET, FILM COATED, EXTENDED RELEASE [RANBAXY PHARMACEUTICALS INC.]1
colloidal silicon dioxideINACTIVE INGREDIENTETJ7Z6XBU4CLARITHROMYCIN EXTENDED RELEASE (CLARITHROMYCIN) TABLET, FILM COATED, EXTENDED RELEASE [RANBAXY PHARMACEUTICALS INC.]1
D & C yellow No 10 aluminum lakeINACTIVE INGREDIENTCLARITHROMYCIN EXTENDED RELEASE (CLARITHROMYCIN) TABLET, FILM COATED, EXTENDED RELEASE [RANBAXY PHARMACEUTICALS INC.]1
fumarateINACTIVE INGREDIENTCLARITHROMYCIN EXTENDED RELEASE (CLARITHROMYCIN) TABLET, FILM COATED, EXTENDED RELEASE [RANBAXY PHARMACEUTICALS INC.]1
hydroxypropyl celluloseINACTIVE INGREDIENTRFW2ET671PCLARITHROMYCIN EXTENDED RELEASE (CLARITHROMYCIN) TABLET, FILM COATED, EXTENDED RELEASE [RANBAXY PHARMACEUTICALS INC.]1
hypromelloseINACTIVE INGREDIENTCLARITHROMYCIN EXTENDED RELEASE (CLARITHROMYCIN) TABLET, FILM COATED, EXTENDED RELEASE [RANBAXY PHARMACEUTICALS INC.]1
iron oxide blackINACTIVE INGREDIENTXM0M87F357CLARITHROMYCIN EXTENDED RELEASE (CLARITHROMYCIN) TABLET, FILM COATED, EXTENDED RELEASE [RANBAXY PHARMACEUTICALS INC.]1
lactose monohydrateINACTIVE INGREDIENTEWQ57Q8I5XCLARITHROMYCIN EXTENDED RELEASE (CLARITHROMYCIN) TABLET, FILM COATED, EXTENDED RELEASE [RANBAXY PHARMACEUTICALS INC.]1
magnesium stearateINACTIVE INGREDIENT70097M6I30CLARITHROMYCIN EXTENDED RELEASE (CLARITHROMYCIN) TABLET, FILM COATED, EXTENDED RELEASE [RANBAXY PHARMACEUTICALS INC.]1
polyethylene glycolINACTIVE INGREDIENTCLARITHROMYCIN EXTENDED RELEASE (CLARITHROMYCIN) TABLET, FILM COATED, EXTENDED RELEASE [RANBAXY PHARMACEUTICALS INC.]1
polysorbateINACTIVE INGREDIENTCLARITHROMYCIN EXTENDED RELEASE (CLARITHROMYCIN) TABLET, FILM COATED, EXTENDED RELEASE [RANBAXY PHARMACEUTICALS INC.]1
povidoneINACTIVE INGREDIENTFZ989GH94ECLARITHROMYCIN EXTENDED RELEASE (CLARITHROMYCIN) TABLET, FILM COATED, EXTENDED RELEASE [RANBAXY PHARMACEUTICALS INC.]1
propylene glycolINACTIVE INGREDIENT6DC9Q167V3CLARITHROMYCIN EXTENDED RELEASE (CLARITHROMYCIN) TABLET, FILM COATED, EXTENDED RELEASE [RANBAXY PHARMACEUTICALS INC.]1
shellacINACTIVE INGREDIENTCLARITHROMYCIN EXTENDED RELEASE (CLARITHROMYCIN) TABLET, FILM COATED, EXTENDED RELEASE [RANBAXY PHARMACEUTICALS INC.]1
sodium stearylINACTIVE INGREDIENTCLARITHROMYCIN EXTENDED RELEASE (CLARITHROMYCIN) TABLET, FILM COATED, EXTENDED RELEASE [RANBAXY PHARMACEUTICALS INC.]1
talcINACTIVE INGREDIENT7SEV7J4R1UCLARITHROMYCIN EXTENDED RELEASE (CLARITHROMYCIN) TABLET, FILM COATED, EXTENDED RELEASE [RANBAXY PHARMACEUTICALS INC.]1
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPCLARITHROMYCIN EXTENDED RELEASE (CLARITHROMYCIN) TABLET, FILM COATED, EXTENDED RELEASE [RANBAXY 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 2 of 3 · 41 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ClarithromycinCLARITHROMYCINA-S Medication Solutions25debd85-0840-4f8d-9898-027772061dd22025-06-09Warnings, Adverse reactionsName fallback
brand name: Clarithromycin
ClarithromycinCLARITHROMYCINCoupler LLC2d6cfd87-9b8c-bba9-e063-6294a90aff5a2025-02-05Warnings, Adverse reactionsName fallback
brand name: Clarithromycin
ClarithromycinCLARITHROMYCINNuCare Pharmaceuticals,Inc.9143b79c-4c79-43ac-e053-2995a90ad7082025-02-04Warnings, Adverse reactionsName fallback
brand name: Clarithromycin
ClarithromycinCLARITHROMYCINDirectRxd22bd12c-737b-4aab-e053-2995a90aff602025-01-20Warnings, Adverse reactionsName fallback
brand name: Clarithromycin
ClarithromycinCLARITHROMYCINBryant Ranch Prepack27e02b77-4332-49e0-8d0c-a072cf5dff922024-05-01Warnings, Adverse reactionsName fallback
brand name: Clarithromycin
ClarithromycinCLARITHROMYCINProficient Rx LP28f60574-4ecd-441c-aebe-5b1d18033ef62024-02-01Warnings, Adverse reactionsName fallback
brand name: Clarithromycin
ClarithromycinCLARITHROMYCINBryant Ranch Prepack0c7d8391-50ef-4827-abe6-e0fc0c2f16362024-01-16Warnings, Adverse reactionsName fallback
brand name: Clarithromycin
ClarithromycinCLARITHROMYCINRising Pharma Holdings, Inc.0c4db97f-f4c9-4cac-9f12-9db1d967ebeb2024-01-05Warnings, Adverse reactionsName fallback
brand name: Clarithromycin
ClarithromycinCLARITHROMYCINA-S Medication Solutionsadba78c2-9e51-4bed-8c6a-6f977f79c40c2023-12-14Warnings, Adverse reactionsName fallback
brand name: Clarithromycin
ClarithromycinCLARITHROMYCINLannett Company, Inc.9bf207c0-86eb-4f3b-92e7-f65f3fccd5a72023-11-13Warnings, Adverse reactionsName fallback
brand name: Clarithromycin
ClarithromycinCLARITHROMYCINAurobindo Pharma Limited9aaffb41-408c-4372-8fd5-1d649450c0e92023-10-10Warnings, Adverse reactionsName fallback
brand name: Clarithromycin
ClarithromycinCLARITHROMYCINLannett Company, Inc.71a836d0-d60f-6418-e053-2a95a90aa6ef2023-09-22Warnings, Adverse reactionsName fallback
brand name: Clarithromycin
ClarithromycinCLARITHROMYCINSandoz Inc22457862-0f88-4be8-b507-1c8f264269f22023-09-13Warnings, Adverse reactionsName fallback
brand name: Clarithromycin
ClarithromycinCLARITHROMYCINA-S Medication Solutions1d6f5a9d-51b2-4e0d-b573-ccf08fe6ea232023-07-31Warnings, Adverse reactionsName fallback
brand name: Clarithromycin
ClarithromycinCLARITHROMYCINSandoz Incb98b02bb-2609-49a0-b29f-e5911aa0cbc12023-05-30Warnings, Adverse reactionsName fallback
brand name: Clarithromycin
ClarithromycinCLARITHROMYCINAlembic Pharmaceuticals Limited268d21f9-02c9-41b0-9487-7968ea12720d2023-05-29Warnings, Adverse reactionsName fallback
brand name: Clarithromycin
ClarithromycinCLARITHROMYCINAlembic Pharmaceuticals Inc.cde51c9f-f7b8-413f-8b8e-e56370cd57542023-05-26Warnings, Adverse reactionsName fallback
brand name: Clarithromycin
CLARITHROMYCINCLARITHROMYCINChartwell RX, LLC.99d2fd6b-39ca-42f9-ad06-30e7fbc22c472022-12-23Warnings, Adverse reactionsName fallback
brand name: CLARITHROMYCIN
Polyethylene GlycolPOLYETHYLENE GLYCOLBluePoint Laboratoriesc4cae70c-68da-0bbc-e053-2a95a90a395a2021-09-20WarningsName fallback
brand name: Polyethylene Glycol
ClarithromycinCLARITHROMYCINProficient Rx LPb1bdf526-4f16-4130-b614-4cb678f060d72021-01-01Warnings, Adverse reactionsName fallback
brand name: Clarithromycin

Reported adverse events (FAERS/openFDA)#

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