Prescription drug · NDA
Aspruzyo Sprinkle (Ranolazine) NDC 47335-625
Ranolazine 1000 mg/1 · Granule · Oral · SUN PHARMACEUTICAL INDUSTRIES, INC.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 47335-625-11 | 47335062511 | 1 GRANULE in 1 PACKET (47335-625-11)Marketed from Feb 28, 2022 | |
| 47335-625-30 | 47335062530 | 30 GRANULE in 1 CARTON (47335-625-30)Marketed from Feb 28, 2022 | |
| 47335-625-60 | 47335062560 | 60 GRANULE in 1 CARTON (47335-625-60)Marketed from Feb 28, 2022 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Aspruzyo Sprinkle
- Generic name (nonproprietary)
- ranolazine
- Active ingredients
- Ranolazine — 1000 mg/1
- Dosage form
- Granule
- Route
- Oral
- Labeler
- SUN PHARMACEUTICAL INDUSTRIES, INC.NDC labeler code 47335
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 216018
- Marketing start
- Listing expires
- Other FDA classes
- Cytochrome P450 2D6 Inhibitors (Mechanism)Cytochrome P450 3A Inhibitors (Mechanism)Organic Cation Transporter 2 Inhibitors (Mechanism)P-Glycoprotein Inhibitors (Mechanism)
- Identifiers
- Product ID 47335-625_2cd273e4-313f-3562-e063-6394a90ac135SPL ID 2cd273e4-313f-3562-e063-6394a90ac135SPL set ID dd9f81e4-50da-4551-aed5-559d304df42eRxCUI 2594753, 2594759, 2594760, 2594762UNII A6IEZ5M406
- Pharmacologic class
- Anti-anginal
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N447335062511followed by a unit qualifier and the quantityPackage 47335-0625-11. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
ASPRUZYO Sprinkle is indicated for the treatment of chronic angina. ASPRUZYO Sprinkle may be used with beta-blockers, nitrates, calcium channel blockers, anti‑platelet therapy, lipid-lowering therapy, ACE inhibitors, and angiotensin receptor blockers. ASPRUZYO Sprinkle is an antianginal indicated for the treatment of chronic angina. (1)
Excerpt only. Read the full label for complete information.
About NDC 47335-625
- What is NDC 47335-625?
- 47335-625 is the product NDC for Aspruzyo Sprinkle (ranolazine), Ranolazine 1000 mg/1 granule, listed with the FDA by SUN PHARMACEUTICAL INDUSTRIES, INC.. It has 3 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Aspruzyo Sprinkle (Ranolazine).
- What is the active ingredient?
- Ranolazine.
- Who is the labeler?
- SUN PHARMACEUTICAL INDUSTRIES, INC., NDC labeler code 47335. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Aspruzyo Sprinkle?
- None: this is the only finished product listed under this name.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.