RANOLAZINE
- Product NDC
- 71610-971
- 11-digit product format
- 716100971
- Labeler code
- 71610
- Product ID
- 71610-971_45236b92-015e-16d3-e063-6394a90a1068
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- RANOLAZINE
- Dosage form
- TABLET, FILM COATED, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Aphena Pharma Solutions - Tennessee, LLC
- Application
- ANDA211829
- Marketing category
- ANDA
- Marketing start
- 2025-06-30
- Substance
- RANOLAZINE
- Active strength
- 500 mg/1
- Pharmacologic classes
- Anti-anginal [EPC], Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- RANOLAZINE
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| RANOLAZINE | 500 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | A6IEZ5M406 |
| Rxcui | 616749 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 71610-971-42 | RANOLAZINE | 1800 in 1 BOTTLE | TABLET, FILM COATED, EXTENDED RE | 1800 | | 1 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 71610-971-42 | 71610097142 | 1800 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71610-971-42) | 2025-12-03 | No | No | Historical |