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NDC 59651-0009-18 Ranolazine 500 mg/1 Details
Ranolazine 500 mg/1
Ranolazine is a ORAL TABLET, FILM COATED, EXTENDED RELEASE in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Aurobindo Pharma Limited. The primary component is RANOLAZINE.
Product Information
| NDC | 59651-0009 |
|---|---|
| Product ID | 59651-009_49873158-5c0a-41da-86a2-369ef6b0cbc8 |
| Associated GPIs | |
| GCN Sequence Number | 060333 |
| GCN Sequence Number Description | ranolazine TAB ER 12H 500 MG ORAL |
| HIC3 | A2C |
| HIC3 Description | ANTIANGINAL, ANTI-ISCHEMIC AGENTS,NON-HEMODYNAMIC |
| GCN | 26459 |
| 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, FILM COATED, EXTENDED RELEASE |
| Route | ORAL |
| Active Ingredient Strength | 500 |
| Active Ingredient Units | mg/1 |
| Substance Name | RANOLAZINE |
| Labeler Name | Aurobindo Pharma Limited |
| 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 | ANDA209081 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 59651-0009-18 (59651000918)
| NDC Package Code | 59651-009-18 |
|---|---|
| Billing NDC | 59651000918 |
| Package | 180 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (59651-009-18) |
| Marketing Start Date | 2022-12-23 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |