NDC 43975-290

Ranolazine

Ranolazine

Ranolazine is a Oral Tablet, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Amerigen Pharmaceuticals Inc.. The primary component is Ranolazine.

Product ID43975-290_34d2ef38-81f2-43c2-807b-492444c9492e
NDC43975-290
Product TypeHuman Prescription Drug
Proprietary NameRanolazine
Generic NameRanolazine
Dosage FormTablet, Extended Release
Route of AdministrationORAL
Marketing Start Date2019-10-29
Marketing CategoryANDA / DRUG FOR FURTHER PROCESSING
Application NumberANDA210482
Labeler NameAmerigen Pharmaceuticals Inc.
Substance NameRANOLAZINE
Active Ingredient Strength500 mg/1
Pharm ClassesAnti-anginal [EPC],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 43975-290-06

60 TABLET, EXTENDED RELEASE in 1 BOTTLE (43975-290-06)
Marketing Start Date2020-01-23
Marketing End Date2021-11-30
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 43975-290-50 [43975029050]

Ranolazine TABLET, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA210482
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2020-01-23
Marketing End Date2020-01-23

NDC 43975-290-06 [43975029006]

Ranolazine TABLET, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA210482
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2020-01-23

Drug Details

Active Ingredients

IngredientStrength
RANOLAZINE500 mg/1

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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