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Chlorhexidine Gluconate

Approved
Approval ID

46fa4977-989e-4bc7-a8d6-89d1e4c431ce

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Feb 6, 2018

Manufacturers
FDA

Carilion Materials Management

DUNS: 079239644

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Chlorhexidine Gluconate

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code68151-5230
Application NumberANDA077789
Product Classification
M
Marketing Category
C73584
G
Generic Name
Chlorhexidine Gluconate
Product Specifications
Route of AdministrationORAL
Effective DateOctober 17, 2017
FDA Product Classification

INGREDIENTS (7)

GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
PEG-40 SORBITAN DIISOSTEARATEInactive
Code: JL4CCU7I1G
Classification: IACT
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
SACCHARIN SODIUMInactive
Code: SB8ZUX40TY
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
CHLORHEXIDINE GLUCONATEActive
Quantity: 1.2 mg in 1 mL
Code: MOR84MUD8E
Classification: ACTIB

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Chlorhexidine Gluconate - FDA Drug Approval Details