RANOLAZINE is a Oral Tablet, Film Coated, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Aphena Pharma Solutions - Tennessee, Llc. The primary component is Ranolazine.
| Product ID | 71610-322_ebab2e5e-06e9-4d86-a335-cf9d48b2e9ed |
| NDC | 71610-322 |
| Product Type | Human Prescription Drug |
| Proprietary Name | RANOLAZINE |
| Generic Name | Ranolazine |
| Dosage Form | Tablet, Film Coated, Extended Release |
| Route of Administration | ORAL |
| Marketing Start Date | 2019-06-04 |
| Marketing Category | ANDA / ANDA |
| Application Number | ANDA211829 |
| Labeler Name | Aphena Pharma Solutions - Tennessee, LLC |
| Substance Name | RANOLAZINE |
| Active Ingredient Strength | 500 mg/1 |
| Pharm Classes | Anti-anginal [EPC],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA] |
| NDC Exclude Flag | N |
| Listing Certified Through | 2020-12-31 |
| Marketing Start Date | 2019-08-13 |
| NDC Exclude Flag | N |
| Sample Package? | N |
| Marketing Category | ANDA |
| Application Number | ANDA211829 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | EA |
| Marketing Start Date | 2019-08-13 |
| Ingredient | Strength |
|---|---|
| RANOLAZINE | 500 mg/1 |
| SPL SET ID: | c842805c-c78d-474e-8a33-c2e828bad800 |
| Manufacturer | |
| UNII | |
| RxNorm Concept Unique ID - RxCUI |
| NDC | Brand Name | Generic Name |
|---|---|---|
| 27241-125 | Ranolazine | Ranolazine |
| 27241-126 | Ranolazine | Ranolazine |
| 31722-668 | Ranolazine | Ranolazine |
| 31722-669 | Ranolazine | Ranolazine |
| 42291-773 | Ranolazine | RANOLAZINE |
| 42291-774 | Ranolazine | RANOLAZINE |
| 42385-963 | Ranolazine | Ranolazine |
| 42385-964 | Ranolazine | Ranolazine |
| 42571-324 | Ranolazine | Ranolazine |
| 42571-325 | Ranolazine | Ranolazine |
| 43975-289 | Ranolazine | Ranolazine |
| 43975-290 | Ranolazine | Ranolazine |
| 45963-418 | Ranolazine | Ranolazine |
| 45963-419 | Ranolazine | Ranolazine |
| 48792-7893 | RANOLAZINE | ranolazine |
| 48792-7894 | RANOLAZINE | ranolazine |
| 50228-423 | RANOLAZINE | RANOLAZINE |
| 50228-424 | RANOLAZINE | RANOLAZINE |
| 50268-722 | Ranolazine | Ranolazine |
| 68180-355 | RANOLAZINE | RANOLAZINE |
| 68180-354 | RANOLAZINE | RANOLAZINE |
| 63304-017 | Ranolazine | Ranolazine |
| 63304-018 | Ranolazine | Ranolazine |
| 69097-222 | Ranolazine | Ranolazine |
| 69097-221 | Ranolazine | Ranolazine |
| 51407-226 | RANOLAZINE | RANOLAZINE |
| 51407-225 | RANOLAZINE | RANOLAZINE |
| 68462-319 | Ranolazine | Ranolazine |
| 68462-320 | Ranolazine | Ranolazine |
| 71610-322 | RANOLAZINE | RANOLAZINE |
| 72578-065 | Ranolazine | Ranolazine |
| 72578-064 | Ranolazine | Ranolazine |
| 70771-1500 | Ranolazine | Ranolazine |
| 70771-1499 | Ranolazine | Ranolazine |
| 47335-624 | ASPRUZYO SPRINKLE | Ranolazine |
| 47335-625 | ASPRUZYO SPRINKLE | Ranolazine |
| 43353-880 | Ranexa | RANOLAZINE |