Registrants1
Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.
Blenheim Pharmacal, Inc.
171434587
Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Blenheim Pharmacal, Inc.
Blenheim Pharmacal, Inc.
Blenheim Pharmacal, Inc.
171434587
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
10544-522Application Number
ANDA065266Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
January 12, 2016ClarithromycinActive
Code: H1250JIK0AClass: ACTIBQuantity: 500 mg in 1 1
HYDROXYPROPYL CELLULOSEInactive
Code: RFW2ET671PClass: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WOClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
POLYETHYLENE GLYCOLSInactive
Code: 3WJQ0SDW1AClass: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2Class: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT