Prescription drug · NDA
Valstar (Valrubicin) NDC 67979-001
Valrubicin 40 mg/mL · Solution, Concentrate · Intravesical · Endo USA, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 67979-001-01 | 6797900010167979000101 | 4 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
N467979000101followed by a unit qualifier and the quantityPackage 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.
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.