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FDA Approval

Chlorthalidone

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

FDA Approval Summary

Company
Effective Date
April 30, 2019
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Chlorthalidone(25 mg in 1 1)

Manufacturing Establishments1

FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.

A-S Medication Solutions

A-S Medication Solutions

830016429

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
50090-3910
Application Number
ANDA089286
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
April 3, 2018
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
Code: Q0MQD1073QClass: ACTIBQuantity: 25 mg in 1 1
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
LACTOSE, UNSPECIFIED FORMInactive
Code: J2B2A4N98GClass: IACT
CROSPOVIDONE (15 MPA.S AT 5%)Inactive
Code: 68401960MKClass: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3GClass: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8Class: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141JClass: IACT
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