FDA.reportPublic FDA data

NDC 63304-971-70 - 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
63304-971
Requested NDC
63304-971-70
Package NDCs from labels
63304-971-05, 63304-971-14, 63304-971-70
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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63304-971CLARITHROMYCIN EXTENDED RELEASE (CLARITHROMYCIN) TABLET, FILM COATED, EXTENDED RELEASE [RANBAXY PHARMACEUTICALS INC.]1Unmatched20080908_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 1 of 3 · 41 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ClarithromycinCLARITHROMYCINREMEDYREPACK INC.9d5848f0-e9f0-4112-a7ca-bcc8ea2e69c62026-06-24Warnings, Adverse reactionsName fallback
brand name: Clarithromycin
ClarithromycinCLARITHROMYCINSportpharm LLCde33ba3a-9df1-4076-8d5f-b603d26980962026-04-17Warnings, Adverse reactionsName fallback
brand name: Clarithromycin
ClarithromycinCLARITHROMYCINSolaris Pharma Corporation4d42821d-ce7a-7d64-e063-6294a90a08752026-04-09Warnings, Adverse reactionsName fallback
brand name: Clarithromycin
ClarithromycinCLARITHROMYCINProficient Rx LP88c7ded8-333c-408d-b693-a72881710f592026-04-01Warnings, Adverse reactionsName fallback
brand name: Clarithromycin
ClarithromycinCLARITHROMYCINPreferred Pharmaceuticals Inc.81c0c69e-b1ae-42f3-9e85-09b8daa75d8d2026-03-30Warnings, Adverse reactionsName fallback
brand name: Clarithromycin
ClarithromycinCLARITHROMYCINMajor Pharmaceuticalsd0a66646-6774-4fc6-9b26-a98c3a5df2742026-03-26Warnings, Adverse reactionsName fallback
brand name: Clarithromycin
ClarithromycinCLARITHROMYCINAmerican Health Packaging59ebe6cb-c830-45c7-8242-52f9f42a90a02026-03-19Warnings, Adverse reactionsName fallback
brand name: Clarithromycin
ClarithromycinCLARITHROMYCINSolaris Pharma Corporation4d4303f8-88dd-8b88-e063-6394a90ab48f2026-03-17Warnings, Adverse reactionsName fallback
brand name: Clarithromycin
ClarithromycinCLARITHROMYCINAmerican Health Packagingfa69ea92-0b41-43fb-918f-ed80e0dedf042026-03-04Warnings, Adverse reactionsName fallback
brand name: Clarithromycin
ClarithromycinCLARITHROMYCINA-S Medication Solutionsfad1e5a3-59f9-4868-9937-d3b061ab8f002026-02-19Warnings, Adverse reactionsName fallback
brand name: Clarithromycin
ClarithromycinCLARITHROMYCINAvPAK1920f943-bbf1-cfd9-7475-96a35680a9e02026-02-11Warnings, Adverse reactionsName fallback
brand name: Clarithromycin
ClarithromycinCLARITHROMYCINNorthwind Health Company, LLC471f638a-9dd1-09d3-e063-6294a90a2d4f2026-01-08Warnings, Adverse reactionsName fallback
brand name: Clarithromycin
ClarithromycinCLARITHROMYCINNorthwind Health Company, LLCf98aacb4-2f01-3e94-e053-6294a90a9aa02026-01-01Warnings, Adverse reactionsName fallback
brand name: Clarithromycin
CLARITHROMYCINCLARITHROMYCINChartwell RX, LLCdea5bd78-7f93-4bc4-a2e4-1b021f5fe0982025-12-10Warnings, Adverse reactionsName fallback
brand name: CLARITHROMYCIN
ClarithromycinCLARITHROMYCINProficient Rx LP9eb306e0-ccfb-418c-82ca-204f20a788f72025-11-01Warnings, Adverse reactionsName fallback
brand name: Clarithromycin
ClarithromycinCLARITHROMYCINPD-Rx Pharmaceuticals, Inc.1d328f5d-73c1-4df7-a3df-71d0e02211812025-10-17Warnings, Adverse reactionsName fallback
brand name: Clarithromycin
ClarithromycinCLARITHROMYCINPD-Rx Pharmaceuticals, Inc.1cb8a78a-0f07-49e8-a23e-a776280062092025-10-16Warnings, Adverse reactionsName fallback
brand name: Clarithromycin
ClarithromycinCLARITHROMYCINPD-Rx Pharmaceuticals, Inc.0be243c6-de02-45dd-8210-cab1bbc8dfa72025-10-15Warnings, Adverse reactionsName fallback
brand name: Clarithromycin
ClarithromycinCLARITHROMYCINDirect_Rx3ba1da51-ba5b-323f-e063-6294a90a03332025-09-08Warnings, Adverse reactionsName fallback
brand name: Clarithromycin
ClarithromycinCLARITHROMYCINPD-Rx Pharmaceuticals, Inc.ba216276-b0bd-420a-9e0d-090bdfcc24602025-08-05Warnings, Adverse reactionsName fallback
brand name: Clarithromycin

Reported adverse events (FAERS/openFDA)#

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