Potassium Chloride
Potassium Chloride Extended-Release Capsules, USP Novel Laboratories, Inc. Rx Only
Approved
Approval ID
5bc4e170-9088-46ba-ade4-05b6027da6c4
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 20, 2019
Manufacturers
FDA
Novel Laboratories, Inc.
DUNS: 793518643
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Potassium Chloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code40032-911
Application NumberANDA204828
Product Classification
M
Marketing Category
C73584
G
Generic Name
Potassium Chloride
Product Specifications
Route of AdministrationORAL
Effective DateDecember 20, 2019
FDA Product Classification
INGREDIENTS (7)
POTASSIUM CHLORIDEActive
Quantity: 10 meq in 1 1
Code: 660YQ98I10
Classification: ACTIB
ETHYLCELLULOSESInactive
Code: 7Z8S9VYZ4B
Classification: IACT
TRIETHYL CITRATEInactive
Code: 8Z96QXD6UM
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
Potassium Chloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code40032-910
Application NumberANDA204828
Product Classification
M
Marketing Category
C73584
G
Generic Name
Potassium Chloride
Product Specifications
Route of AdministrationORAL
Effective DateDecember 20, 2019
FDA Product Classification
INGREDIENTS (5)
POTASSIUM CHLORIDEActive
Quantity: 8 meq in 1 1
Code: 660YQ98I10
Classification: ACTIB
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
ETHYLCELLULOSESInactive
Code: 7Z8S9VYZ4B
Classification: IACT
TRIETHYL CITRATEInactive
Code: 8Z96QXD6UM
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT