Registrants1
Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.
Bryant Ranch Prepack
171714327
Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Bryant Ranch Prepack
Bryant Ranch Prepack
Bryant Ranch Prepack
171714327
Products1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Chlorthalidone
Product Details
NDC Product Code
72162-2133Application Number
ANDA212878Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
September 20, 2023ChlorthalidoneActive
Code: Q0MQD1073QClass: ACTIBQuantity: 25 mg in 1 1
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
MICROCRYSTALLINE CELLULOSE 101Inactive
Code: 7T9FYH5QMKClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
POVIDONE K30Inactive
Code: U725QWY32XClass: IACT
SODIUM STARCH GLYCOLATE TYPE AInactive
Code: H8AV0SQX4DClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3GClass: IACT