aspruzyo sprinkle

Generic: ranolazine

Labeler: sun pharmaceutical industries, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name aspruzyo sprinkle
Generic Name ranolazine
Labeler sun pharmaceutical industries, inc.
Dosage Form GRANULE
Routes
ORAL
Active Ingredients

ranolazine 1000 mg/1

Manufacturer
SUN PHARMACEUTICAL INDUSTRIES, INC.

Identifiers & Regulatory

Product NDC 47335-625
Product ID 47335-625_2cd273e4-313f-3562-e063-6394a90ac135
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA216018
Listing Expiration 2026-12-31
Marketing Start 2022-02-28

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 47335625
Hyphenated Format 47335-625

Supplemental Identifiers

RxCUI
2594753 2594759 2594760 2594762
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 aspruzyo sprinkle (source: ndc)
Generic Name ranolazine (source: ndc)
Application Number NDA216018 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 1000 mg/1
source: ndc
Packaging
  • 1 GRANULE in 1 PACKET (47335-625-11)
  • 30 GRANULE in 1 CARTON (47335-625-30)
  • 60 GRANULE in 1 CARTON (47335-625-60)
source: ndc

Packages (3)

47335-625-11 1 GRANULE in 1 PACKET (47335-625-11) 47335-625-30 30 GRANULE in 1 CARTON (47335-625-30) 47335-625-60 60 GRANULE in 1 CARTON (47335-625-60)

Ingredients (1)

ranolazine (1000 mg/1)

Linked Drug Pages (1)

ASPRUZYO SPRINKLE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "2cd273e4-313f-3562-e063-6394a90ac135", "openfda": {"nui": ["N0000175427", "N0000190114", "N0000185503", "N0000182137", "N0000187061"], "unii": ["A6IEZ5M406"], "rxcui": ["2594753", "2594759", "2594760", "2594762"], "spl_set_id": ["dd9f81e4-50da-4551-aed5-559d304df42e"], "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": ["SUN PHARMACEUTICAL INDUSTRIES, INC."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 GRANULE in 1 PACKET (47335-625-11)", "package_ndc": "47335-625-11", "marketing_start_date": "20220228"}, {"sample": false, "description": "30 GRANULE in 1 CARTON (47335-625-30)", "package_ndc": "47335-625-30", "marketing_start_date": "20220228"}, {"sample": false, "description": "60 GRANULE in 1 CARTON (47335-625-60)", "package_ndc": "47335-625-60", "marketing_start_date": "20220228"}], "brand_name": "ASPRUZYO SPRINKLE", "product_id": "47335-625_2cd273e4-313f-3562-e063-6394a90ac135", "dosage_form": "GRANULE", "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": "47335-625", "generic_name": "Ranolazine", "labeler_name": "SUN PHARMACEUTICAL INDUSTRIES, INC.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "ASPRUZYO SPRINKLE", "active_ingredients": [{"name": "RANOLAZINE", "strength": "1000 mg/1"}], "application_number": "NDA216018", "marketing_category": "NDA", "marketing_start_date": "20220228", "listing_expiration_date": "20261231"}