Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Alembic Pharmaceuticals Limited
Alembic Pharmaceuticals Limited
650574671
Products2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
CHLORTHALIDONE CHLORTHALIDONE
Product Details
NDC Product Code
46708-677Application Number
ANDA216262Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
September 6, 2022ChlorthalidoneActive
Code: Q0MQD1073QClass: ACTIBQuantity: 50 mg in 1 1
SODIUM STARCH GLYCOLATE TYPE A CORNInactive
Code: AG9B65PV6BClass: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65APClass: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
D&C YELLOW NO. 10 ALUMINUM LAKEInactive
Code: CQ3XH3DET6Class: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBDClass: IACT
CHLORTHALIDONE CHLORTHALIDONE
Product Details
NDC Product Code
46708-676Application Number
ANDA216262Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
September 6, 2022ChlorthalidoneActive
Code: Q0MQD1073QClass: ACTIBQuantity: 25 mg in 1 1
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
SODIUM STARCH GLYCOLATE TYPE A CORNInactive
Code: AG9B65PV6BClass: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65APClass: IACT
D&C YELLOW NO. 10 ALUMINUM LAKEInactive
Code: CQ3XH3DET6Class: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBDClass: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT