NDC codes

FDA NDC Directory
Product NDC (as listed)63323-926Labeler and product segments. Claims need a package NDC.
Product NDC at billing width63323-0926Add 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
63323-926-88633230926881 KIT in 1 CARTON (63323-926-88) * 2 mL in 1 VIAL, SINGLE-DOSE (63323-925-17) * 2.2 mL in 1 VIAL, SINGLE-DOSE (63323-922-03)Marketed from Oct 12, 2021

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)
Romidepsin
Generic name (nonproprietary)
romidepsin
Dosage form
Kit
Labeler
Fresenius Kabi USA, LLCNDC labeler code 63323
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 206254
Marketing start
Listing expires
Identifiers
Product ID 63323-926_44fb8ff4-ec3d-4dcf-8e8c-207545d938a3SPL ID 44fb8ff4-ec3d-4dcf-8e8c-207545d938a3SPL set ID 73a2028d-6735-4cd4-b63d-d072df9927a1RxCUI 877513UPC 0363323925178

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

N463323092688 followed by a unit qualifier and the quantity

Package 63323-0926-88. 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)

Romidepsin for injection is indicated for the treatment of cutaneous T-cell lymphoma (CTCL) in adult patients who have received at least one prior systemic therapy. Romidepsin for injection is a histone deacetylase (HDAC) inhibitor indicated for the treatment of cutaneous T-cell lymphoma (CTCL) in adult patients who have received at least one prior systemic therapy ( 1 ).

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 63323-926

What is NDC 63323-926?
63323-926 is the product NDC for Romidepsin kit, listed with the FDA by Fresenius Kabi USA, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Romidepsin.
Who is the labeler?
Fresenius Kabi USA, LLC, NDC labeler code 63323. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Romidepsin?
1 other product NDC are listed under this name. See all Romidepsin 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 Romidepsin NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
RomidepsinRomidepsin 5 mg/mLInjection, Solution, ConcentrateIntravenousAmneal Pharmaceuticals LLC70121-225070121-2250-01

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