zypitamag

Generic: pitavastatin magnesium

Labeler: zydus lifesciences limited
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name zypitamag
Generic Name pitavastatin magnesium
Labeler zydus lifesciences limited
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

pitavastatin 2 mg/1

Manufacturer
Zydus Lifesciences Limited

Identifiers & Regulatory

Product NDC 70771-1117
Product ID 70771-1117_8eab99e7-f5e0-4b8a-8cc6-2d90618ebf93
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA208379
Listing Expiration 2026-12-31
Marketing Start 2018-03-09

Pharmacologic Class

Established (EPC)
hmg-coa reductase inhibitor [epc]
Mechanism of Action
hydroxymethylglutaryl-coa reductase inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 707711117
Hyphenated Format 70771-1117

Supplemental Identifiers

RxCUI
2001262 2001264 2001266 2001268
UNII
M5681Q5F9P
NUI
N0000175589 N0000000121

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 zypitamag (source: ndc)
Generic Name pitavastatin magnesium (source: ndc)
Application Number NDA208379 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 2 mg/1
source: ndc
Packaging
  • 1000 TABLET, FILM COATED in 1 BOTTLE (70771-1117-0)
  • 100 TABLET, FILM COATED in 1 BOTTLE (70771-1117-1)
  • 30 TABLET, FILM COATED in 1 BOTTLE (70771-1117-3)
  • 10 BLISTER PACK in 1 CARTON (70771-1117-4) / 10 TABLET, FILM COATED in 1 BLISTER PACK
  • 500 TABLET, FILM COATED in 1 BOTTLE (70771-1117-5)
  • 1 BLISTER PACK in 1 CARTON (70771-1117-7) / 7 TABLET, FILM COATED in 1 BLISTER PACK
  • 90 TABLET, FILM COATED in 1 BOTTLE (70771-1117-9)
source: ndc

Packages (7)

70771-1117-0 1000 TABLET, FILM COATED in 1 BOTTLE (70771-1117-0) 70771-1117-1 100 TABLET, FILM COATED in 1 BOTTLE (70771-1117-1) 70771-1117-3 30 TABLET, FILM COATED in 1 BOTTLE (70771-1117-3) 70771-1117-4 10 BLISTER PACK in 1 CARTON (70771-1117-4) / 10 TABLET, FILM COATED in 1 BLISTER PACK 70771-1117-5 500 TABLET, FILM COATED in 1 BOTTLE (70771-1117-5) 70771-1117-7 1 BLISTER PACK in 1 CARTON (70771-1117-7) / 7 TABLET, FILM COATED in 1 BLISTER PACK 70771-1117-9 90 TABLET, FILM COATED in 1 BOTTLE (70771-1117-9)

Ingredients (1)

pitavastatin (2 mg/1)

Linked Drug Pages (1)

ZYPITAMAG ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "8eab99e7-f5e0-4b8a-8cc6-2d90618ebf93", "openfda": {"nui": ["N0000175589", "N0000000121"], "unii": ["M5681Q5F9P"], "rxcui": ["2001262", "2001264", "2001266", "2001268"], "spl_set_id": ["e9f0fe3a-0462-4c24-8f22-3c89afe8fcea"], "pharm_class_epc": ["HMG-CoA Reductase Inhibitor [EPC]"], "pharm_class_moa": ["Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]"], "manufacturer_name": ["Zydus Lifesciences Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1000 TABLET, FILM COATED in 1 BOTTLE (70771-1117-0)", "package_ndc": "70771-1117-0", "marketing_start_date": "20180309"}, {"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (70771-1117-1)", "package_ndc": "70771-1117-1", "marketing_start_date": "20180309"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (70771-1117-3)", "package_ndc": "70771-1117-3", "marketing_start_date": "20180309"}, {"sample": false, "description": "10 BLISTER PACK in 1 CARTON (70771-1117-4)  / 10 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "70771-1117-4", "marketing_start_date": "20180309"}, {"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE (70771-1117-5)", "package_ndc": "70771-1117-5", "marketing_start_date": "20180309"}, {"sample": false, "description": "1 BLISTER PACK in 1 CARTON (70771-1117-7)  / 7 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "70771-1117-7", "marketing_start_date": "20180309"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (70771-1117-9)", "package_ndc": "70771-1117-9", "marketing_start_date": "20180309"}], "brand_name": "ZYPITAMAG", "product_id": "70771-1117_8eab99e7-f5e0-4b8a-8cc6-2d90618ebf93", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["HMG-CoA Reductase Inhibitor [EPC]", "Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]"], "product_ndc": "70771-1117", "generic_name": "Pitavastatin Magnesium", "labeler_name": "Zydus Lifesciences Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "ZYPITAMAG", "active_ingredients": [{"name": "PITAVASTATIN", "strength": "2 mg/1"}], "application_number": "NDA208379", "marketing_category": "NDA", "marketing_start_date": "20180309", "listing_expiration_date": "20261231"}