Ranolazine
- Product NDC
- 82804-118
- 11-digit product format
- 828040118
- Labeler code
- 82804
- Product ID
- 82804-118_c7ed8234-e6bd-4f19-a1ce-40f272a79036
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ranolazine
- Dosage form
- TABLET, FILM COATED, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Proficient Rx LP
- Application
- ANDA211829
- Marketing category
- ANDA
- Marketing start
- 2021-08-24
- 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 |
|---|
| 82804-118-60 | Ranolazine | 60 in 1 BOTTLE | TABLET, FILM COATED, EXTENDED RE | 60 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 82804-118 | RANOLAZINE TABLET, FILM COATED, EXTENDED RELEASE [PROFICIENT RX LP] | 1 | Current NDC, 1 package rows | 20240711_c7ed8234-e6bd-4f19-a1ce-40f272a79036.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 82804-118-60 | 82804011860 | 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (82804-118-60) | 2024-07-05 | No | No | Current |