Manufacturing Establishments2
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
DR. REDDY'S LABORATORIES LIMITED (FTO-Sez-Process Unit-01)
Dr.Reddy's Laboratories Limited
860037244
Dr.Reddy's Laboratories Limited
Dr.Reddy's Laboratories Limited
918608162
Products1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Clopidogrel bisulfate
Product Details
NDC Product Code
55111-196Application Number
ANDA076273Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
September 30, 2022ClopidogrelActive
Code: 08I79HTP27Class: ACTIMQuantity: 75 mg in 1 1
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
Croscarmellose SodiumInactive
Code: M28OL1HH48Class: IACT
MannitolInactive
Code: 3OWL53L36AClass: IACT
Hypromellose 2910 (5 Mpa.S)Inactive
Code: R75537T0T4Class: IACT
Cellulose, MicrocrystallineInactive
Code: OP1R32D61UClass: IACT
Polyethylene Glycol 400Inactive
Code: B697894SGQClass: IACT
titanium dioxideInactive
Code: 15FIX9V2JPClass: IACT
Magnesium StearateInactive
Code: 70097M6I30Class: IACT