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FDA Approval

Cholestyramine for Oral Suspension

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

FDA Approval Summary

Company
Chartwell RX, LLC
DUNS: 079394054
Effective Date
January 9, 2023
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Cholestyramine(4 g in 5.7 g)

Products2

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

NDC Product Code
62135-937
Application Number
ANDA074562
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
January 9, 2023
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSLClass: IACT
PECTINInactive
Code: 89NA02M4RXClass: IACT
PROPYLENE GLYCOL ALGINATEInactive
Code: 26CD3J2R0CClass: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
AMMONIUM GLYCYRRHIZATEInactive
Code: 3VRD35U26CClass: IACT
ASPARTAMEInactive
Code: Z0H242BBR1Class: IACT
FRUCTOSEInactive
Code: 6YSS42VSEVClass: IACT
MANNITOLInactive
Code: 3OWL53L36AClass: IACT
SORBITOLInactive
Code: 506T60A25RClass: IACT
D&C RED NO. 30Inactive
Code: 2S42T2808BClass: IACT
XANTHAN GUMInactive
Code: TTV12P4NEEClass: IACT
Code: 4B33BGI082Class: ACTIBQuantity: 4 g in 5.7 g

Cholestyramine for Oral Suspension

Product Details

NDC Product Code
62135-008
Application Number
ANDA074561
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
January 9, 2023
FRUCTOSEInactive
Code: 6YSS42VSEVClass: IACT
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSLClass: IACT
PECTINInactive
Code: 89NA02M4RXClass: IACT
PROPYLENE GLYCOL ALGINATEInactive
Code: 26CD3J2R0CClass: IACT
SORBITOLInactive
Code: 506T60A25RClass: IACT
SUCROSEInactive
Code: C151H8M554Class: IACT
AMMONIUM GLYCYRRHIZATEInactive
Code: 3VRD35U26CClass: IACT
XANTHAN GUMInactive
Code: TTV12P4NEEClass: IACT
D&C RED NO. 30Inactive
Code: 2S42T2808BClass: IACT
Code: 4B33BGI082Class: ACTIBQuantity: 4 g in 9 g

Drug Labeling Information

Complete FDA-approved labeling information including indications, dosage, warnings, contraindications, and other essential prescribing details.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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)


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