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NDC 72578-0065-05 Ranolazine 1000 mg/1 Details
Ranolazine 1000 mg/1
Ranolazine is a ORAL TABLET, EXTENDED RELEASE in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Viona Pharmaceuticals Inc. The primary component is RANOLAZINE.
MedlinePlus Drug Summary
Ranolazine is used alone or with other medications to treat chronic angina (ongoing chest pain or pressure that is felt when the heart does not get enough oxygen). Ranolazine is in a class of medications called anti-anginals. The exact way that ranolazine works is not known at this time.
Related Packages: 72578-0065-05Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Ranolazine
Product Information
NDC | 72578-0065 |
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Product ID | 72578-065_2c72dbc3-5385-4706-b5fd-841d4b70a26f |
Associated GPIs | 32200040007430 |
GCN Sequence Number | 062973 |
GCN Sequence Number Description | ranolazine TAB ER 12H 1000 MG ORAL |
HIC3 | A2C |
HIC3 Description | ANTIANGINAL, ANTI-ISCHEMIC AGENTS,NON-HEMODYNAMIC |
GCN | 98733 |
HICL Sequence Number | 033446 |
HICL Sequence Number Description | RANOLAZINE |
Brand/Generic | Generic |
Proprietary Name | Ranolazine |
Proprietary Name Suffix | n/a |
Non-Proprietary Name | Ranolazine |
Product Type | HUMAN PRESCRIPTION DRUG |
Dosage Form | TABLET, EXTENDED RELEASE |
Route | ORAL |
Active Ingredient Strength | 1000 |
Active Ingredient Units | mg/1 |
Substance Name | RANOLAZINE |
Labeler Name | Viona Pharmaceuticals Inc |
Pharmaceutical Class | Anti-anginal [EPC], Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA] |
DEA Schedule | n/a |
Marketing Category | ANDA |
Application Number | ANDA210188 |
Listing Certified Through | 2024-12-31 |
Package
NDC 72578-0065-05 (72578006505)
NDC Package Code | 72578-065-05 |
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Billing NDC | 72578006505 |
Package | 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (72578-065-05) |
Marketing Start Date | 2019-09-10 |
NDC Exclude Flag | N |
Pricing Information | N/A |