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K-EFFERVESCENT

Approved
Approval ID

5dcd492f-cef1-41ba-b5d2-c79c31601f63

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Sep 20, 2012

Manufacturers
FDA

Qualitest Pharmaceuticals

DUNS: 011103059

Products 1

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

POTASSIUM BICARBONATE

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code0603-4170
Product Classification
G
Generic Name
POTASSIUM BICARBONATE
Product Specifications
Route of AdministrationORAL
Effective DateApril 20, 2012
FDA Product Classification

INGREDIENTS (6)

POLYETHYLENE GLYCOL 8000Inactive
Quantity: 0.103 g in 1 1
Code: Q662QK8M3B
Classification: IACT
SODIUM BENZOATEInactive
Quantity: 0.077 g in 1 1
Code: OJ245FE5EU
Classification: IACT
ANHYDROUS CITRIC ACIDInactive
Quantity: 1.4 g in 1 1
Code: XF417D3PSL
Classification: IACT
POTASSIUM BICARBONATEActive
Quantity: 25 meq in 1 1
Code: HM5Z15LEBN
Classification: ACTIM
SORBITOLInactive
Quantity: 0.971 g in 1 1
Code: 506T60A25R
Classification: IACT
SACCHARIN SODIUM ANHYDROUSInactive
Quantity: 0.039 g in 1 1
Code: I4807BK602
Classification: IACT

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K-EFFERVESCENT - FDA Drug Approval Details