ASPRUZYO SPRINKLE

Product NDC
47335-624
11-digit product format
473350624
Labeler code
47335
Product ID
47335-624_110acc77-c51e-465f-8d01-2c01f69af87b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ranolazine
Dosage form
GRANULE
Route
ORAL
Labeler
SUN PHARMACEUTICAL INDUSTRIES, INC.
Application
NDA216018
Marketing category
NDA
Marketing start
2022-02-28
Marketing end
0000-00-00
Substance
RANOLAZINE
Active strength
500 mg/1
Pharmacologic classes
Anti-anginal [EPC], Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
4367aed1-e488-b72c-d0ec-178a4e054129Product name920250624
ddc83a74-720a-4975-8550-c4bd979c9094Product name120221212

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
47335-624-11ASPRUZYO SPRINKLE1 in 1 PACKETGRANULE13
47335-624-30ASPRUZYO SPRINKLE30 in 1 CARTONGRANULE303
47335-624-60ASPRUZYO SPRINKLE60 in 1 CARTONGRANULE603

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
47335-624-11EA - Each47335-62464c00877-ceaf-44b5-8cd1-4da023827e6312022-08-04
47335-624-60EA - Each47335-624d2534668-2131-42ef-8610-300eb93c131812022-07-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
47335-624ASPRUZYO SPRINKLE (RANOLAZINE) GRANULE [SUN PHARMACEUTICAL INDUSTRIES, INC.]3Legacy NDC, 3 package rows20250130_dd9f81e4-50da-4551-aed5-559d304df42e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2594759ASPRUZYO Sprinkle 1000 MG Oral GranulesPSNdd9f81e4-50da-4551-aed5-559d304df42e3
2594762ASPRUZYO Sprinkle 500 MG Oral GranulesPSNdd9f81e4-50da-4551-aed5-559d304df42e3
2594753ranolazine 1000 MG Oral GranulesPSNdd9f81e4-50da-4551-aed5-559d304df42e3
2594760ranolazine 500 MG Oral GranulesPSNdd9f81e4-50da-4551-aed5-559d304df42e3
2594759ranolazine 1000 MG Oral Granules [Aspruzyo]SBDdd9f81e4-50da-4551-aed5-559d304df42e3
2594762ranolazine 500 MG Oral Granules [Aspruzyo]SBDdd9f81e4-50da-4551-aed5-559d304df42e3
2594753ranolazine 1000 MG Oral GranulesSCDdd9f81e4-50da-4551-aed5-559d304df42e3
2594760ranolazine 500 MG Oral GranulesSCDdd9f81e4-50da-4551-aed5-559d304df42e3
2594759Aspruzyo 1000 MG Oral GranulesSYdd9f81e4-50da-4551-aed5-559d304df42e3
2594762Aspruzyo 500 MG Oral GranulesSYdd9f81e4-50da-4551-aed5-559d304df42e3
2594759Aspruzyo Sprinkle 1 GM Oral GranulesSYdd9f81e4-50da-4551-aed5-559d304df42e3
2594759Aspruzyo Sprinkle 1000 MG Oral GranulesSYdd9f81e4-50da-4551-aed5-559d304df42e3
2594762Aspruzyo Sprinkle 500 MG Oral GranulesSYdd9f81e4-50da-4551-aed5-559d304df42e3
2594753ranolazine 1 GM Oral GranulesSYdd9f81e4-50da-4551-aed5-559d304df42e3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
47335-624-11473350624111 GRANULE in 1 PACKET (47335-624-11) 1 granule2022-02-280000-00-00NoNoCurrent
47335-624-304733506243030 GRANULE in 1 CARTON (47335-624-30) 30 granule2022-02-280000-00-00NoNoCurrent
47335-624-604733506246060 GRANULE in 1 CARTON (47335-624-60) 60 granule2022-02-280000-00-00NoNoCurrent