Prescription drug · NDA
Cisplatin NDC 44567-530
Cisplatin 50 mg/1 · Injection, Powder, Lyophilized, For solution · Intravenous · WG Critical Care, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 44567-530-01 | 44567053001 | 1 VIAL in 1 CARTON (44567-530-01) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIALMarketed from Apr 5, 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)
- Cisplatin
- Generic name (nonproprietary)
- cisplatin
- Active ingredients
- Cisplatin — 50 mg/1
- Dosage form
- Injection, Powder, Lyophilized, For solution
- Route
- Intravenous
- Labeler
- WG Critical Care, LLC
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 018057
- Marketing start
- Listing expires
- Other FDA classes
- Platinum-containing Compounds (EXT)
- Identifiers
- Product ID 44567-530_bf273433-d76e-4071-99a9-a71caf064734SPL ID bf273433-d76e-4071-99a9-a71caf064734SPL set ID 508496cb-3441-46b3-a4fe-e0d440e6adc6RxCUI 1736854UNII Q20Q21Q62J
- Pharmacologic class
- Platinum-based Drug
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.
- Administration
Drug administration (CPT 96360–96549)
When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.
- NDC on a medical claim
N444567053001followed by a unit qualifier and the quantityPackage 44567-0530-01. 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 . This label includes a boxed warning.
Indications (excerpt from the label)
Cisplatin for injection is a platinum-based drug indicated for the treatment of: • Advanced testicular cancer ( 1.1 ) • Advanced ovarian cancer ( 1.2 ) • Advanced bladder cancer ( 1.3 ) 1.1 Advanced Testicular Cancer Cisplatin for injection is indicated for the treatment of advanced testicular cancer. 1.2 Advanced Ovarian Cancer Cisplatin for injection is indicated for the treatment of advanced ovarian cancer. 1.3 Advanced Bladder Cancer Cisplatin for injection is indicated for the treatment of advanced bladder cancer.
Excerpt only. Read the full label for complete information.
Other NDCs under NDA 018057
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| CISplatin | Cisplatin 1 mg/mL | Injection, SolutionIntravenous | WG Critical Care, LLC | 44567-510 |
| CISplatin | Cisplatin 1 mg/mL | Injection, SolutionIntravenous | WG Critical Care, LLC | 44567-509 |
| CISplatin | Cisplatin 1 mg/mL | Injection, SolutionIntravenous | WG Critical Care, LLC | 44567-511 |