NDC codes

FDA NDC Directory
Product NDC (as listed)67979-001Labeler and product segments. Claims need a package NDC.
Product NDC at billing width67979-0001Add 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
67979-001-0167979000101679790001014 VIAL in 1 CARTON (67979-001-01) / 5 mL in 1 VIALMarketed from Oct 1, 1998

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)
Valstar
Generic name (nonproprietary)
valrubicin
Active ingredients
Valrubicin — 40 mg/mL
Dosage form
Solution, Concentrate
Route
Intravesical
Labeler
Endo USA, Inc.NDC labeler code 67979
Product type
Prescription drug
Marketing category
NDA — New Drug ApplicationApplication NDA 020892
Marketing start
Listing expires
Identifiers
Product ID 67979-001_25cb4a4a-e28a-c674-e063-6294a90a0bddSPL ID 25cb4a4a-e28a-c674-e063-6294a90a0bddSPL set ID e96f30a0-6662-11de-8f80-0002a5d5c51bRxCUI 262063, 313567UNII 2C6NUM6878

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

N467979000101 followed by a unit qualifier and the quantity

Package 67979-0001-01. 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)

VALSTAR is an anthracycline topoisomerase inhibitor indicated for intravesical therapy of BCG-refractory carcinoma in situ (CIS) of the urinary bladder in patients for whom immediate cystectomy would be associated with unacceptable morbidity or mortality. VALSTAR is an anthracycline topoisomerase inhibitor indicated for intravesical therapy of BCG-refractory carcinoma in situ (CIS) of the urinary bladder in patients for whom immediate cystectomy would be associated with unacceptable morbidity or mortality. ( 1 )

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 67979-001

What is NDC 67979-001?
67979-001 is the product NDC for Valstar (valrubicin), Valrubicin 40 mg/mL solution, concentrate, listed with the FDA by Endo USA, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Valstar (Valrubicin).
What is the active ingredient?
Valrubicin.
Who is the labeler?
Endo USA, Inc., NDC labeler code 67979. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Valstar?
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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