ranolazine

Generic: ranolazine

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

Drug Facts

Product Profile

Brand Name ranolazine
Generic Name ranolazine
Labeler zydus lifesciences limited
Dosage Form TABLET, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

ranolazine 1000 mg/1

Manufacturer
Zydus Lifesciences Limited

Identifiers & Regulatory

Product NDC 70771-1500
Product ID 70771-1500_b80bd37e-952a-4a30-9b48-6dca616f181d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA210188
Listing Expiration 2027-12-31
Marketing Start 2019-09-10

Pharmacologic Class

Established (EPC)
anti-anginal [epc]
Mechanism of Action
cytochrome p450 3a inhibitors [moa] p-glycoprotein inhibitors [moa] cytochrome p450 2d6 inhibitors [moa] organic cation transporter 2 inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 707711500
Hyphenated Format 70771-1500

Supplemental Identifiers

RxCUI
616749 728231
UNII
A6IEZ5M406
NUI
N0000175427 N0000190114 N0000185503 N0000182137 N0000187061

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 ranolazine (source: ndc)
Generic Name ranolazine (source: ndc)
Application Number ANDA210188 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 1000 mg/1
source: ndc
Packaging
  • 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (70771-1500-1)
  • 10 BLISTER PACK in 1 CARTON (70771-1500-4) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (70771-1500-2)
  • 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (70771-1500-5)
  • 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (70771-1500-6)
source: ndc

Packages (4)

70771-1500-1 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (70771-1500-1) 70771-1500-4 10 BLISTER PACK in 1 CARTON (70771-1500-4) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (70771-1500-2) 70771-1500-5 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (70771-1500-5) 70771-1500-6 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (70771-1500-6)

Ingredients (1)

ranolazine (1000 mg/1)

Linked Drug Pages (1)

Ranolazine ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "b80bd37e-952a-4a30-9b48-6dca616f181d", "openfda": {"nui": ["N0000175427", "N0000190114", "N0000185503", "N0000182137", "N0000187061"], "unii": ["A6IEZ5M406"], "rxcui": ["616749", "728231"], "spl_set_id": ["d74f3dea-7357-4e9a-be9a-2f498a44108a"], "pharm_class_epc": ["Anti-anginal [EPC]"], "pharm_class_moa": ["Cytochrome P450 3A Inhibitors [MoA]", "P-Glycoprotein Inhibitors [MoA]", "Cytochrome P450 2D6 Inhibitors [MoA]", "Organic Cation Transporter 2 Inhibitors [MoA]"], "manufacturer_name": ["Zydus Lifesciences Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, EXTENDED RELEASE in 1 BOTTLE (70771-1500-1)", "package_ndc": "70771-1500-1", "marketing_start_date": "20190910"}, {"sample": false, "description": "10 BLISTER PACK in 1 CARTON (70771-1500-4)  / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (70771-1500-2)", "package_ndc": "70771-1500-4", "marketing_start_date": "20190910"}, {"sample": false, "description": "500 TABLET, EXTENDED RELEASE in 1 BOTTLE (70771-1500-5)", "package_ndc": "70771-1500-5", "marketing_start_date": "20190910"}, {"sample": false, "description": "60 TABLET, EXTENDED RELEASE in 1 BOTTLE (70771-1500-6)", "package_ndc": "70771-1500-6", "marketing_start_date": "20190910"}], "brand_name": "Ranolazine", "product_id": "70771-1500_b80bd37e-952a-4a30-9b48-6dca616f181d", "dosage_form": "TABLET, EXTENDED RELEASE", "pharm_class": ["Anti-anginal [EPC]", "Cytochrome P450 2D6 Inhibitors [MoA]", "Cytochrome P450 3A Inhibitors [MoA]", "Organic Cation Transporter 2 Inhibitors [MoA]", "P-Glycoprotein Inhibitors [MoA]"], "product_ndc": "70771-1500", "generic_name": "Ranolazine", "labeler_name": "Zydus Lifesciences Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Ranolazine", "active_ingredients": [{"name": "RANOLAZINE", "strength": "1000 mg/1"}], "application_number": "ANDA210188", "marketing_category": "ANDA", "marketing_start_date": "20190910", "listing_expiration_date": "20271231"}