cholestyramine

Generic: cholestyramine

Labeler: zydus pharmaceuticals (usa) inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name cholestyramine
Generic Name cholestyramine
Labeler zydus pharmaceuticals (usa) inc.
Dosage Form POWDER, FOR SUSPENSION
Routes
ORAL
Active Ingredients

cholestyramine 4 g/9g

Manufacturer
Zydus Pharmaceuticals (USA) Inc.

Identifiers & Regulatory

Product NDC 68382-528
Product ID 68382-528_b1884e46-cf18-4a7e-b003-761878e77bf1
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA202901
Listing Expiration 2026-12-31
Marketing Start 2018-08-01

Pharmacologic Class

Established (EPC)
bile acid sequestrant [epc]
Mechanism of Action
bile-acid binding activity [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68382528
Hyphenated Format 68382-528

Supplemental Identifiers

RxCUI
848943
UNII
4B33BGI082
NUI
N0000180292 N0000175365

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name cholestyramine (source: ndc)
Generic Name cholestyramine (source: ndc)
Application Number ANDA202901 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 4 g/9g
source: ndc
Packaging
  • 378 g in 1 CAN (68382-528-42)
  • 60 POUCH in 1 CARTON (68382-528-60) / 9 g in 1 POUCH
source: ndc

Packages (2)

68382-528-42 378 g in 1 CAN (68382-528-42) 68382-528-60 60 POUCH in 1 CARTON (68382-528-60) / 9 g in 1 POUCH

Ingredients (1)

cholestyramine (4 g/9g)

Linked Drug Pages (1)

CHOLESTYRAMINE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "b1884e46-cf18-4a7e-b003-761878e77bf1", "openfda": {"nui": ["N0000180292", "N0000175365"], "unii": ["4B33BGI082"], "rxcui": ["848943"], "spl_set_id": ["acc48703-c15b-4275-aa75-749f1c07dcbb"], "pharm_class_epc": ["Bile Acid Sequestrant [EPC]"], "pharm_class_moa": ["Bile-acid Binding Activity [MoA]"], "manufacturer_name": ["Zydus Pharmaceuticals (USA) Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "378 g in 1 CAN (68382-528-42)", "package_ndc": "68382-528-42", "marketing_start_date": "20180801"}, {"sample": false, "description": "60 POUCH in 1 CARTON (68382-528-60)  / 9 g in 1 POUCH", "package_ndc": "68382-528-60", "marketing_start_date": "20180801"}], "brand_name": "CHOLESTYRAMINE", "product_id": "68382-528_b1884e46-cf18-4a7e-b003-761878e77bf1", "dosage_form": "POWDER, FOR SUSPENSION", "pharm_class": ["Bile Acid Sequestrant [EPC]", "Bile-acid Binding Activity [MoA]"], "product_ndc": "68382-528", "generic_name": "CHOLESTYRAMINE", "labeler_name": "Zydus Pharmaceuticals (USA) Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "CHOLESTYRAMINE", "active_ingredients": [{"name": "CHOLESTYRAMINE", "strength": "4 g/9g"}], "application_number": "ANDA202901", "marketing_category": "ANDA", "marketing_start_date": "20180801", "listing_expiration_date": "20261231"}