NDC codes

FDA NDC Directory
Product NDC (as listed)47335-625Labeler and product segments. Claims need a package NDC.
Product NDC at billing width47335-0625Add the package segment from the table below.
Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC11-digit (billing)PackageCopy
47335-625-11473350625111 GRANULE in 1 PACKET (47335-625-11)Marketed from Feb 28, 2022
47335-625-304733506253030 GRANULE in 1 CARTON (47335-625-30)Marketed from Feb 28, 2022
47335-625-604733506256060 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

N447335062511 followed by a unit qualifier and the quantity

Package 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.

Full label on DailyMed (opens in a new tab)

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.

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