Chlorthalidone
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Approved
Approval ID
15dd224a-87ad-48dc-80b1-e8382a452c4c
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 20, 2019
Manufacturers
FDA
Mylan Pharmaceuticals Inc.
DUNS: 059295980
Products 2
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 Code0378-0222
Application NumberANDA086831
Product Classification
M
Marketing Category
C73584
G
Generic Name
chlorthalidone
Product Specifications
Route of AdministrationORAL
Effective DateAugust 20, 2019
FDA Product Classification
INGREDIENTS (7)
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
CHLORTHALIDONEActive
Quantity: 25 mg in 1 1
Code: Q0MQD1073Q
Classification: ACTIB
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
chlorthalidone
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0378-0213
Application NumberANDA086831
Product Classification
M
Marketing Category
C73584
G
Generic Name
chlorthalidone
Product Specifications
Route of AdministrationORAL
Effective DateAugust 20, 2019
FDA Product Classification
INGREDIENTS (8)
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
CHLORTHALIDONEActive
Quantity: 50 mg in 1 1
Code: Q0MQD1073Q
Classification: ACTIB
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT