Chlorthalidone
Chlorthalidone Tablets USP 25mg and 50mg
Approved
Approval ID
dea660bd-d4cc-4c5b-9c6d-674a6dc1c9c2
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 3, 2021
Manufacturers
FDA
Aphena Pharma Solutions - Tennessee, LLC
DUNS: 128385585
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Chlorthalidone
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code71610-029
Application NumberANDA089286
Product Classification
M
Marketing Category
C73584
G
Generic Name
Chlorthalidone
Product Specifications
Route of AdministrationORAL
Effective DateAugust 3, 2021
FDA Product Classification
INGREDIENTS (10)
CHLORTHALIDONEActive
Quantity: 25 mg in 1 1
Code: Q0MQD1073Q
Classification: ACTIB
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CROSPOVIDONE (15 MPA.S AT 5%)Inactive
Code: 68401960MK
Classification: IACT
LACTOSE, UNSPECIFIED FORMInactive
Code: J2B2A4N98G
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT