NDC 69097-222

Ranolazine

Ranolazine

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

Product ID69097-222_7141ddf2-9c11-4d86-a0b3-ec7fd7e035b0
NDC69097-222
Product TypeHuman Prescription Drug
Proprietary NameRanolazine
Generic NameRanolazine
Dosage FormTablet, Film Coated, Extended Release
Route of AdministrationORAL
Marketing Start Date2019-05-28
Marketing CategoryANDA / ANDA
Application NumberANDA211291
Labeler NameCipla USA Inc.
Substance NameRANOLAZINE
Active Ingredient Strength1000 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 Through2021-12-31

Packaging

NDC 69097-222-02

30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (69097-222-02)
Marketing Start Date2019-05-28
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 69097-222-12 [69097022212]

Ranolazine TABLET, FILM COATED, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA211291
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-05-28

NDC 69097-222-02 [69097022202]

Ranolazine TABLET, FILM COATED, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA211291
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-05-28

NDC 69097-222-03 [69097022203]

Ranolazine TABLET, FILM COATED, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA211291
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-05-28

Drug Details

Active Ingredients

IngredientStrength
RANOLAZINE1000 mg/1

Pharmacological Class

  • Anti-anginal [EPC]
  • Cytochrome P450 3A Inhibitors [MoA]
  • P-Glycoprotein Inhibitors [MoA]
  • Cytochrome P450 2D6 Inhibitors [MoA]
  • Organic Cation Transporter 2 Inhibitors [MoA]

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
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.