rosuvastatin calcium

Generic: rosuvastatin calcium

Labeler: novadoz pharmaceuticals llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name rosuvastatin calcium
Generic Name rosuvastatin calcium
Labeler novadoz pharmaceuticals llc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

rosuvastatin calcium 5 mg/1

Manufacturer
Novadoz Pharmaceuticals LLC

Identifiers & Regulatory

Product NDC 72205-002
Product ID 72205-002_62787a4a-6d53-43a3-a0b7-ed0b6037d18e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA208898
Listing Expiration 2026-12-31
Marketing Start 2017-11-22

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 72205002
Hyphenated Format 72205-002

Supplemental Identifiers

RxCUI
859419 859424 859747 859751
UPC
0372205027053 0372205004993 0372205005990 0372205027992 0372205003903 0372205004900 0372205005051 0372205003996 0372205004054 0372205027909 0372205005907 0372205005303 0372205003057
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 rosuvastatin calcium (source: ndc)
Generic Name rosuvastatin calcium (source: ndc)
Application Number ANDA208898 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 16 HOW SUPPLIED/STORAGE AND HANDLING Rosuvastatin tablets, USP are supplied as: Strength How Supplied NDC Tablet Description 5 mg Bottle of 90 tablets 72205-027-90 White, round shaped, biconvex, film coated tablets debossed with "R5" on one side and plain on other side. Bottle of 500 tablets 72205-027-05 Bottle of 1000 tablets 72205-027-99 Cartons of 100 (10 x 10) unit-dose tablets 72205-027-06 10 mg Bottle of 90 tablets 72205-003-90 Pink, round shaped, biconvex, film coated tablets debossed with "R10" on one side and plain on other side. Bottle of 500 tablets 72205-003-05 Bottle of 1000 tablets 72205-003-99 Cartons of 100 (10 x 10) unit-dose tablets 72205-003-06 20 mg Bottle of 90 tablets 72205-004-90 Pink, round shaped, biconvex, film coated tablets debossed with "R20" on one side and plain on other side. Bottle of 500 tablets 72205-004-05 Bottle of 1000 tablets 72205-004-99 Cartons of 100 (10 x 10) unit-dose tablets 72205-004-06 40 mg Bottle of 30 tablets 72205-005-30 Pink, oval shaped, biconvex, film coated tablets debossed with "R" on one side and "40" on other side. Bottle of 90 tablets 72205-005-90 Bottle of 500 tablets 72205-005-05 Bottle of 1000 tablets 72205-005-99 Cartons of 100 (10 x 10) unit-dose tablets 72205-005-06 Storage Store at controlled room temperature, 20ºC to 25ºC (68ºF to 77ºF); excursions permitted between 15°C and 30°C (59°F and 86°F) [see USP Controlled Room Temperature]. Protect from moisture.
  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL 5 mg-Container-Label-90's Count 5 mg-Container-Label-500's Count 5 mg-Container-Label-1000's Count 10 mg-container-Label-90's count 10 mg-Container-Label-500's Count 10 mg-container-Label-1000's-count 20 mg-container-Label-90's-Count 20 mg-Container-Label-500's Count 20 mg-Container-Label-1000's-Count 40 mg-Container-Label-30's-Count 40 mg-Container-Label-90's-Count 40 mg-Container-Label-500's Count 40 mg-Container-Label-1000's-Count rosuvastatin-5mg-90s rosuvastatin-5mg-500s rosuvastatin-5mg-1000s rosuvastatin-10mg-90s rosuvastatin-10mg-500s rosuvastatin-10mg-1000s rosuvastatin-20mg-90s rosuvastatin-20mg-500s rosuvastatin-20mg-1000s rosuvastatin-40mg-30s rosuvastatin-40mg-90s rosuvastatin-40mg-500s rosuvastatin-40mg-1000s
source: label

Packages (0)

No package records.

Ingredients (1)

rosuvastatin calcium (5 mg/1)

Linked Drug Pages (1)

Rosuvastatin Calcium ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "62787a4a-6d53-43a3-a0b7-ed0b6037d18e", "openfda": {"upc": ["0372205027053", "0372205004993", "0372205005990", "0372205027992", "0372205003903", "0372205004900", "0372205005051", "0372205003996", "0372205004054", "0372205027909", "0372205005907", "0372205005303", "0372205003057"], "unii": ["83MVU38M7Q"], "rxcui": ["859419", "859424", "859747", "859751"], "spl_set_id": ["d58f1f63-4bb6-413c-9730-ded3e8078618"], "manufacturer_name": ["Novadoz Pharmaceuticals LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [], "brand_name": "Rosuvastatin Calcium", "product_id": "72205-002_62787a4a-6d53-43a3-a0b7-ed0b6037d18e", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["HMG-CoA Reductase Inhibitor [EPC]", "Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]"], "product_ndc": "72205-002", "generic_name": "Rosuvastatin Calcium", "labeler_name": "Novadoz Pharmaceuticals LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Rosuvastatin Calcium", "active_ingredients": [{"name": "ROSUVASTATIN CALCIUM", "strength": "5 mg/1"}], "application_number": "ANDA208898", "marketing_category": "ANDA", "marketing_start_date": "20171122", "listing_expiration_date": "20261231"}