NDC codes

FDA NDC Directory
Product NDC (as listed)70510-2321Labeler and product segments. Claims need a package NDC.
Product NDC at billing width70510-2321Add 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
70510-2321-2705102321022 CARTON in 1 CARTON (70510-2321-2) / 1 KIT in 1 CARTON (70510-2321-1) * 1 BOTTLE in 1 KIT (70510-2323-1) / 35 mL in 1 BOTTLEMarketed from May 12, 2022

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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)
Radicava Ors
Generic name (nonproprietary)
edaravone
Dosage form
Kit
Labeler
Shionogi Inc.NDC labeler code 70510
Product type
Prescription drug
Marketing category
NDA — New Drug ApplicationApplication NDA 215446
Marketing start
Listing expires
Identifiers
Product ID 70510-2321_9f9d17c0-7426-4713-885d-fb22a34b7028SPL ID 9f9d17c0-7426-4713-885d-fb22a34b7028SPL set ID 0ce2c1c4-2a40-485c-b7cb-96a9b85d9d11RxCUI 1924316, 1924317, 2602117, 2602122UPC 0370510232414, 0370510217121, 0370510232315

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 drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.

NDC on a medical claim

N470510232102 followed by a unit qualifier and the quantity

Package 70510-2321-02. 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)

RADICAVA and RADICAVA ORS are indicated for the treatment of amyotrophic lateral sclerosis (ALS). RADICAVA and RADICAVA ORS are indicated for the treatment of amyotrophic lateral sclerosis (ALS). ( 1 )

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 70510-2321

What is NDC 70510-2321?
70510-2321 is the product NDC for Radicava Ors (edaravone) kit, listed with the FDA by Shionogi Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Radicava Ors (Edaravone).
Who is the labeler?
Shionogi Inc., NDC labeler code 70510. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Radicava Ors?
1 other product NDC are listed under this name. See all Radicava Ors 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 Radicava Ors NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Radicava Orsedaravone—KitShionogi Inc.70510-232270510-2322-01

Other NDCs under NDA 215446

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

FDA NDC Directory listings under NDA 215446
ProductStrengthForm · routeLabelerProduct NDC
Radicava Orsedaravone—KitShionogi Inc.70510-2322

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