crestor

Generic: rosuvastatin

Labeler: astrazeneca pharmaceuticals lp
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name crestor
Generic Name rosuvastatin
Labeler astrazeneca pharmaceuticals lp
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

rosuvastatin calcium 5 mg/1

Manufacturer
AstraZeneca Pharmaceuticals LP

Identifiers & Regulatory

Product NDC 0310-7560
Product ID 0310-7560_60f99621-0a0e-4fef-a6f7-3d28d5fa5011
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA021366
Listing Expiration 2026-12-31
Marketing Start 2022-05-09

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 03107560
Hyphenated Format 0310-7560

Supplemental Identifiers

RxCUI
859419 859421 859424 859426 859747 859749 859751 859753
UPC
0303107560904 0303107570903 0303107590307 0303107580902
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 crestor (source: ndc)
Generic Name rosuvastatin (source: ndc)
Application Number NDA021366 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 90 TABLET, FILM COATED in 1 BOTTLE (0310-7560-90)
source: ndc

Packages (1)

0310-7560-90 90 TABLET, FILM COATED in 1 BOTTLE (0310-7560-90)

Ingredients (1)

rosuvastatin calcium (5 mg/1)

Linked Drug Pages (1)

Crestor ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "60f99621-0a0e-4fef-a6f7-3d28d5fa5011", "openfda": {"upc": ["0303107560904", "0303107570903", "0303107590307", "0303107580902"], "unii": ["83MVU38M7Q"], "rxcui": ["859419", "859421", "859424", "859426", "859747", "859749", "859751", "859753"], "spl_set_id": ["325a5d0e-9a72-4015-9fcd-1655fb504cee"], "manufacturer_name": ["AstraZeneca Pharmaceuticals LP"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (0310-7560-90)", "package_ndc": "0310-7560-90", "marketing_start_date": "20220509"}], "brand_name": "Crestor", "product_id": "0310-7560_60f99621-0a0e-4fef-a6f7-3d28d5fa5011", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["HMG-CoA Reductase Inhibitor [EPC]", "Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]"], "product_ndc": "0310-7560", "generic_name": "Rosuvastatin", "labeler_name": "AstraZeneca Pharmaceuticals LP", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Crestor", "active_ingredients": [{"name": "ROSUVASTATIN CALCIUM", "strength": "5 mg/1"}], "application_number": "NDA021366", "marketing_category": "NDA", "marketing_start_date": "20220509", "listing_expiration_date": "20261231"}