NDC codes

FDA NDC Directory
Product NDC (as listed)47335-401Labeler and product segments. Claims need a package NDC.
Product NDC at billing width47335-0401Add 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
47335-401-814733504018147335040181120 TABLET in 1 BOTTLE, PLASTIC (47335-401-81)Marketed from May 22, 2018

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)
Yonsa
Generic name (nonproprietary)
abiraterone acetate
Active ingredients
Abiraterone acetate — 125 mg/1
Dosage form
Tablet
Route
Oral
Labeler
Sun Pharmaceutical Industries, Inc.NDC labeler code 47335
Product type
Prescription drug
Marketing category
NDA — New Drug ApplicationApplication NDA 210308
Marketing start
Listing expires
Other FDA classes
Cytochrome P450 17A1 Inhibitors (Mechanism)Cytochrome P450 2C8 Inhibitors (Mechanism)Cytochrome P450 2D6 Inhibitors (Mechanism)
Identifiers
Product ID 47335-401_7cc706b3-7d39-405d-91a4-5a7d433b4d2fSPL ID 7cc706b3-7d39-405d-91a4-5a7d433b4d2f
Pharmacologic class
Cytochrome P450 17A1 Inhibitor

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

N447335040181 followed by a unit qualifier and the quantity

Package 47335-0401-81. 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

The FDA listing for this product does not reference a label (SPL) set.

About NDC 47335-401

What is NDC 47335-401?
47335-401 is the product NDC for Yonsa (abiraterone acetate), Abiraterone acetate 125 mg/1 tablet, listed with the FDA by Sun Pharmaceutical Industries, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Yonsa (Abiraterone acetate).
What is the active ingredient?
Abiraterone acetate.
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 Yonsa?
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.

Other NDCs under NDA 210308

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under NDA 210308
ProductStrengthForm · routeLabelerProduct NDC
Abiraterone AcetateAbiraterone acetate 125 mg/1TabletOralGolden State Medical Supply, Inc.51407-503

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