NDC codes

FDA NDC Directory
Product NDC (as listed)64980-418Labeler and product segments. Claims need a package NDC.
Product NDC at billing width64980-0418Add 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
64980-418-126498004181264980041812120 TABLET in 1 BOTTLE (64980-418-12)Marketed from Feb 25, 2019

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)
Abiraterone acetate
Generic name (nonproprietary)
abiraterone acetate
Active ingredients
Abiraterone acetate — 250 mg/1
Dosage form
Tablet
Route
Oral
Labeler
Rising Pharma Holdings, Inc.NDC labeler code 64980
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 208371
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 64980-418_36a3afb4-e212-4881-865f-90349c009e70SPL ID 36a3afb4-e212-4881-865f-90349c009e70SPL set ID 54ae5ef9-aea5-484a-a473-863b1397e206RxCUI 1100075UNII EM5OCB9YJ6UPC 0364980418126
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

N464980041812 followed by a unit qualifier and the quantity

Package 64980-0418-12. 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)

Abiraterone acetate tablets are indicated in combination with prednisone for the treatment of patients with • Metastatic castration-resistant prostate cancer (CRPC) • Metastatic high-risk castration-sensitive prostate cancer (CSPC) Abiraterone acetate tablets are a CYP17 inhibitor indicated in combination with prednisone for the treatment of patients with • metastatic castration-resistant prostate cancer (CRPC). ( 1 ) • metastatic high-risk castration-sensitive prostate cancer (CSPC). ( 1 )

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 64980-418

What is NDC 64980-418?
64980-418 is the product NDC for Abiraterone acetate, Abiraterone acetate 250 mg/1 tablet, listed with the FDA by Rising Pharma Holdings, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Abiraterone acetate.
What is the active ingredient?
Abiraterone acetate.
Who is the labeler?
Rising Pharma Holdings, Inc., NDC labeler code 64980. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Abiraterone acetate?
28 other product NDCs are listed under this name. See all Abiraterone acetate NDCs.
Is there a related HCPCS / J-code?
Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Abiraterone acetate NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Abiraterone AcetateAbiraterone acetate 250 mg/1TabletOralAvPAK50268-03250268-0032-12
Abiraterone AcetateAbiraterone acetate 250 mg/1TabletOralDr. Reddys Laboratories Inc75907-22475907-0224-04
Abiraterone AcetateabirateroneAbiraterone acetate 250 mg/1TabletOralAmerican Health Packaging60687-79060687-0790-21
Abiraterone AcetateAbiraterone acetate 500 mg/1TabletOralDr. Reddys Laboratories Inc43598-46843598-0468-3843598-0468-60
Abiraterone AcetateabirateroneAbiraterone acetate 250 mg/1TabletOralAmneal Pharmaceuticals LLC60219-116560219-1165-07
Abiraterone AcetateabirateroneAbiraterone acetate 500 mg/1TabletOralAmneal Pharmaceuticals LLC60219-175460219-1754-06
Abiraterone acetateAbiraterone acetate 500 mg/1Tablet, Film coatedOralFlorida Pharmaceutical Products, LLC71921-17771921-0177-06
abiraterone acetateAbiraterone acetate 250 mg/1TabletOralFlorida Pharmaceutical Products, LLC.71921-17871921-0178-20
abiraterone acetateAbiraterone acetate 500 mg/1TabletOralGlenmark Pharmaceuticals Inc., USA68462-88268462-0882-60
abiraterone acetateAbiraterone acetate 500 mg/1TabletOralNORTHSTAR RX LLC72603-11172603-0111-01

All 29 Abiraterone acetate NDCs

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