MedPath
FDA Approval

Clarithromycin

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

FDA Approval Summary

Company
Effective Date
December 6, 2023
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Clarithromycin(500 mg in 1 1)

Manufacturing Establishments1

FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.

NuCare Pharmaceuticals,Inc.

NuCare Pharmaceuticals,Inc.

010632300

Products1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Clarithromycin

Product Details

NDC Product Code
68071-5045
Application Number
ANDA065489
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
December 6, 2023
HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive
Code: RFW2ET671PClass: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
POVIDONE K30Inactive
Code: U725QWY32XClass: IACT
HYPROMELLOSE 2910 (15 MPA.S)Inactive
Code: 36SFW2JZ0WClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRTClass: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3Class: IACT
VANILLINInactive
Code: CHI530446XClass: IACT
SORBIC ACIDInactive
Code: X045WJ989BClass: IACT
Code: H1250JIK0AClass: ACTIBQuantity: 500 mg in 1 1
© Copyright 2025. All Rights Reserved by MedPath