ASPRUZYO SPRINKLE
- Product NDC
- 47335-625
- 11-digit product format
- 473350625
- Labeler code
- 47335
- Product ID
- 47335-625_2cd273e4-313f-3562-e063-6394a90ac135
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ranolazine
- Dosage form
- GRANULE
- Route
- ORAL
- Labeler
- SUN PHARMACEUTICAL INDUSTRIES, INC.
- Application
- NDA216018
- Marketing category
- NDA
- Marketing start
- 2022-02-28
- 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
- ASPRUZYO SPRINKLE
- 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 | 2594753, 2594759, 2594760, 2594762 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 47335-625-11 | ASPRUZYO SPRINKLE | 1 in 1 PACKET | GRANULE | 1 | | 3 |
| 47335-625-30 | ASPRUZYO SPRINKLE | 30 in 1 CARTON | GRANULE | 30 | | 3 |
| 47335-625-60 | ASPRUZYO SPRINKLE | 60 in 1 CARTON | GRANULE | 60 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 47335-625 | ASPRUZYO SPRINKLE (RANOLAZINE) GRANULE [SUN PHARMACEUTICAL INDUSTRIES, INC.] | 3 | Current NDC, Legacy NDC, 3 package rows | 20250130_dd9f81e4-50da-4551-aed5-559d304df42e.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 47335-625-11 | 47335062511 | 1 GRANULE in 1 PACKET (47335-625-11) | 1 granule | 2022-02-28 | 0000-00-00 | No | No | Current |
| 47335-625-30 | 47335062530 | 30 GRANULE in 1 CARTON (47335-625-30) | 30 granule | 2022-02-28 | 0000-00-00 | No | No | Current |
| 47335-625-60 | 47335062560 | 60 GRANULE in 1 CARTON (47335-625-60) | 60 granule | 2022-02-28 | 0000-00-00 | No | No | Current |