ezallor sprinkle

Generic: rosuvastatin

Labeler: sun pharmaceutical industries, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name ezallor sprinkle
Generic Name rosuvastatin
Labeler sun pharmaceutical industries, inc.
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

rosuvastatin calcium 10 mg/1

Manufacturer
Sun Pharmaceutical Industries, Inc.

Identifiers & Regulatory

Product NDC 47335-985
Product ID 47335-985_01ae3339-db79-4759-85f9-937689743dc1
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA208647
Listing Expiration 2026-12-31
Marketing Start 2019-05-04

Pharmacologic Class

Classes
hmg-coa reductase inhibitor [epc] hydroxymethylglutaryl-coa reductase inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 47335985
Hyphenated Format 47335-985

Supplemental Identifiers

RxCUI
2167557 2167563 2167565 2167567 2167569 2167571 2167573 2167575
UPC
0347335986839 0347335984835 0347335987836
UNII
83MVU38M7Q

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 ezallor sprinkle (source: ndc)
Generic Name rosuvastatin (source: ndc)
Application Number NDA208647 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 3 BLISTER PACK in 1 CARTON (47335-985-64) / 10 CAPSULE in 1 BLISTER PACK (47335-985-60)
  • 90 CAPSULE in 1 BOTTLE (47335-985-81)
  • 30 CAPSULE in 1 BOTTLE (47335-985-83)
source: ndc

Packages (3)

47335-985-64 3 BLISTER PACK in 1 CARTON (47335-985-64) / 10 CAPSULE in 1 BLISTER PACK (47335-985-60) 47335-985-81 90 CAPSULE in 1 BOTTLE (47335-985-81) 47335-985-83 30 CAPSULE in 1 BOTTLE (47335-985-83)

Ingredients (1)

rosuvastatin calcium (10 mg/1)

Linked Drug Pages (1)

EZALLOR SPRINKLE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "01ae3339-db79-4759-85f9-937689743dc1", "openfda": {"upc": ["0347335986839", "0347335984835", "0347335987836"], "unii": ["83MVU38M7Q"], "rxcui": ["2167557", "2167563", "2167565", "2167567", "2167569", "2167571", "2167573", "2167575"], "spl_set_id": ["619add8c-3e39-4bb7-8828-450bd82c0404"], "manufacturer_name": ["Sun Pharmaceutical Industries, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "3 BLISTER PACK in 1 CARTON (47335-985-64)  / 10 CAPSULE in 1 BLISTER PACK (47335-985-60)", "package_ndc": "47335-985-64", "marketing_start_date": "20190504"}, {"sample": false, "description": "90 CAPSULE in 1 BOTTLE (47335-985-81)", "package_ndc": "47335-985-81", "marketing_start_date": "20190504"}, {"sample": false, "description": "30 CAPSULE in 1 BOTTLE (47335-985-83)", "package_ndc": "47335-985-83", "marketing_start_date": "20190504"}], "brand_name": "EZALLOR SPRINKLE", "product_id": "47335-985_01ae3339-db79-4759-85f9-937689743dc1", "dosage_form": "CAPSULE", "pharm_class": ["HMG-CoA Reductase Inhibitor [EPC]", "Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]"], "product_ndc": "47335-985", "generic_name": "ROSUVASTATIN", "labeler_name": "Sun Pharmaceutical Industries, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "EZALLOR SPRINKLE", "active_ingredients": [{"name": "ROSUVASTATIN CALCIUM", "strength": "10 mg/1"}], "application_number": "NDA208647", "marketing_category": "NDA", "marketing_start_date": "20190504", "listing_expiration_date": "20261231"}