NDC 72319-021

RANOLAZINE

Ranolazine

RANOLAZINE is a Oral Tablet, Film Coated, Extended Release in the Human Prescription Drug category. It is labeled and distributed by I3 Pharmaceuticals, Llc. The primary component is Ranolazine.

Product ID72319-021_163908d8-6b41-4e68-b14c-76faa57c7ac0
NDC72319-021
Product TypeHuman Prescription Drug
Proprietary NameRANOLAZINE
Generic NameRanolazine
Dosage FormTablet, Film Coated, Extended Release
Route of AdministrationORAL
Marketing Start Date2022-06-15
Marketing CategoryANDA /
Application NumberANDA213517
Labeler Namei3 Pharmaceuticals, LLC
Substance NameRANOLAZINE
Active Ingredient Strength500 mg/1
Pharm ClassesAnti-anginal [EPC], Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 72319-021-02

60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (72319-021-02)
Marketing Start Date2022-06-15
NDC Exclude FlagN
Sample Package?N

Drug Details

NDC Crossover Matching brand name "RANOLAZINE" or generic name "Ranolazine"

NDCBrand NameGeneric Name
27241-125RanolazineRanolazine
27241-126RanolazineRanolazine
31722-668RanolazineRanolazine
31722-669RanolazineRanolazine
42291-773RanolazineRANOLAZINE
42291-774RanolazineRANOLAZINE
42385-963RanolazineRanolazine
42385-964RanolazineRanolazine
42571-324RanolazineRanolazine
42571-325RanolazineRanolazine
43975-289RanolazineRanolazine
43975-290RanolazineRanolazine
45963-418RanolazineRanolazine
45963-419RanolazineRanolazine
48792-7893RANOLAZINEranolazine
48792-7894RANOLAZINEranolazine
50228-423RANOLAZINERANOLAZINE
50228-424RANOLAZINERANOLAZINE
50268-722RanolazineRanolazine
68180-355RANOLAZINERANOLAZINE
68180-354RANOLAZINERANOLAZINE
63304-017RanolazineRanolazine
63304-018RanolazineRanolazine
69097-222RanolazineRanolazine
69097-221RanolazineRanolazine
51407-226RANOLAZINERANOLAZINE
51407-225RANOLAZINERANOLAZINE
68462-319RanolazineRanolazine
68462-320RanolazineRanolazine
71610-322RANOLAZINERANOLAZINE
72578-065RanolazineRanolazine
72578-064RanolazineRanolazine
70771-1500RanolazineRanolazine
70771-1499RanolazineRanolazine
47335-624ASPRUZYO SPRINKLERanolazine
47335-625ASPRUZYO SPRINKLERanolazine
43353-880RanexaRANOLAZINE

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