rosuvastain calcium

Generic: rosuvastain calcium

Labeler: chartwell rx, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name rosuvastain calcium
Generic Name rosuvastain calcium
Labeler chartwell rx, llc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

rosuvastatin calcium 5 mg/1

Manufacturer
Chartwell RX, LLC

Identifiers & Regulatory

Product NDC 62135-690
Product ID 62135-690_1d9afa7b-031d-18c5-e063-6294a90a6a7c
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA079168
Listing Expiration 2026-12-31
Marketing Start 2016-07-19

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 62135690
Hyphenated Format 62135-690

Supplemental Identifiers

RxCUI
859419 859424 859747 859751
UPC
0362135692902 0362135690908 0362135691905 0362135693305
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 rosuvastain calcium (source: ndc)
Generic Name rosuvastain calcium (source: ndc)
Application Number ANDA079168 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 90 TABLET, FILM COATED in 1 BOTTLE (62135-690-90)
source: ndc

Packages (1)

62135-690-90 90 TABLET, FILM COATED in 1 BOTTLE (62135-690-90)

Ingredients (1)

rosuvastatin calcium (5 mg/1)

Linked Drug Pages (1)

Rosuvastain Calcium ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "1d9afa7b-031d-18c5-e063-6294a90a6a7c", "openfda": {"upc": ["0362135692902", "0362135690908", "0362135691905", "0362135693305"], "unii": ["83MVU38M7Q"], "rxcui": ["859419", "859424", "859747", "859751"], "spl_set_id": ["a12a99ef-b573-498f-be5a-deb7cd538153"], "manufacturer_name": ["Chartwell RX, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (62135-690-90)", "package_ndc": "62135-690-90", "marketing_start_date": "20240710"}], "brand_name": "Rosuvastain Calcium", "product_id": "62135-690_1d9afa7b-031d-18c5-e063-6294a90a6a7c", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["HMG-CoA Reductase Inhibitor [EPC]", "Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]"], "product_ndc": "62135-690", "generic_name": "Rosuvastain Calcium", "labeler_name": "Chartwell RX, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Rosuvastain Calcium", "active_ingredients": [{"name": "ROSUVASTATIN CALCIUM", "strength": "5 mg/1"}], "application_number": "ANDA079168", "marketing_category": "ANDA", "marketing_start_date": "20160719", "listing_expiration_date": "20261231"}