Cholestyramine for Oral Suspension

Cholestyramine for Oral Suspension, USP

Approved

Approval ID

80db0042-0c05-4509-8a6b-fa9f4783629a

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Jan 9, 2023

Manufacturers

FDA

Chartwell RX, LLC

DUNS: 079394054

Products 2

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

Cholestyramine for Oral Suspension

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code62135-937

Application NumberANDA074562

Product Classification

Marketing Category

C73584

Generic Name

Cholestyramine for Oral Suspension

Product Specifications

Route of AdministrationORAL

Effective DateJanuary 9, 2023

FDA Product Classification

INGREDIENTS (12)

ANHYDROUS CITRIC ACIDInactive

Code: XF417D3PSL

Classification: IACT

PECTINInactive

Code: 89NA02M4RX

Classification: IACT

PROPYLENE GLYCOL ALGINATEInactive

Code: 26CD3J2R0C

Classification: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4

Classification: IACT

AMMONIUM GLYCYRRHIZATEInactive

Code: 3VRD35U26C

Classification: IACT

ASPARTAMEInactive

Code: Z0H242BBR1

Classification: IACT

FRUCTOSEInactive

Code: 6YSS42VSEV

Classification: IACT

MANNITOLInactive

Code: 3OWL53L36A

Classification: IACT

SORBITOLInactive

Code: 506T60A25R

Classification: IACT

D&C RED NO. 30Inactive

Code: 2S42T2808B

Classification: IACT

XANTHAN GUMInactive

Code: TTV12P4NEE

Classification: IACT

CHOLESTYRAMINEActive

Quantity: 4 g in 5.7 g

Code: 4B33BGI082

Classification: ACTIB

Cholestyramine for Oral Suspension

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code62135-008

Application NumberANDA074561

Product Classification

Marketing Category

C73584

Generic Name

Cholestyramine for Oral Suspension

Product Specifications

Route of AdministrationORAL

Effective DateJanuary 9, 2023

FDA Product Classification

INGREDIENTS (10)

FRUCTOSEInactive

Code: 6YSS42VSEV

Classification: IACT

ANHYDROUS CITRIC ACIDInactive

Code: XF417D3PSL

Classification: IACT

PECTINInactive

Code: 89NA02M4RX

Classification: IACT

PROPYLENE GLYCOL ALGINATEInactive

Code: 26CD3J2R0C

Classification: IACT

SORBITOLInactive

Code: 506T60A25R

Classification: IACT

SUCROSEInactive

Code: C151H8M554

Classification: IACT

AMMONIUM GLYCYRRHIZATEInactive

Code: 3VRD35U26C

Classification: IACT

XANTHAN GUMInactive

Code: TTV12P4NEE

Classification: IACT

D&C RED NO. 30Inactive

Code: 2S42T2808B

Classification: IACT

CHOLESTYRAMINEActive

Quantity: 4 g in 9 g

Code: 4B33BGI082

Classification: ACTIB

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 1/4/2023

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Cholestyramine for Oral Suspension USP Powder, 4 Grams Per Scoopful- NDC 62135-008-56 -378g Label

![cholestyramine- ndc62135-008-56-label](/dailymed/image.cfm?name=cholestyramine-4g-per- scoopful-56-label.jpg&id=684897)

Cholestyramine for Oral Suspension USP Powder LIGHT, 4 Grams Per Scoopful- NDC 62135-937-54 -239.4g Label

![cholestyramine- ndc62135-008-54-label](/dailymed/image.cfm?name=cholestyramine-4g-per- scoopful-54-label.jpg&id=684897)

AI-Powered Research

Premium Access

Cholestyramine for Oral Suspension

Products 2

Cholestyramine for Oral Suspension

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (12)

Cholestyramine for Oral Suspension

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (10)

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

MedPath

Product

Company

Legal