Ranolazine
- Product NDC
- 29300-297
- 11-digit product format
- 293000297
- Labeler code
- 29300
- Product ID
- 29300-297_429d55c7-1e90-4345-a6d4-59f689557f40
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ranolazine
- Dosage form
- TABLET, FILM COATED, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Unichem Pharmaceuticals (USA), Inc.
- Application
- ANDA213083
- Marketing category
- ANDA
- Marketing start
- 2023-03-16
- Substance
- RANOLAZINE
- Active strength
- 1000 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 | 1000 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | A6IEZ5M406 |
| Rxcui | 616749, 728231 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 29300-297-01 | Ranolazine | 100 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED, EXTENDED RE | 100 | | 6 |
| 29300-297-16 | Ranolazine | 60 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED, EXTENDED RE | 60 | | 6 |
| 29300-297-52 | Ranolazine | 250 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED, EXTENDED RE | 250 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 29300-297 | RANOLAZINE TABLET, FILM COATED, EXTENDED RELEASE [UNICHEM PHARMACEUTICALS (USA), INC.] | 6 | Current NDC, 3 package rows | 20231107_e2a8c9f9-5f6a-4496-8fd6-2439e564db4f.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 29300-297-01 | 29300029701 | 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (29300-297-01) | 2023-07-15 | No | No | Current |
| 29300-297-16 | 29300029716 | 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (29300-297-16) | 2023-07-15 | No | No | Current |
| 29300-297-52 | 29300029752 | 250 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (29300-297-52) | 2023-07-15 | No | No | Current |