Prescription drug · ANDA
Cisplatin NDC 72266-252
Cisplatin 1 mg/mL · Injection, Solution · Intravenous · FOSUN PHARMA USA INC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 72266-252-01 | 72266025201 | 1 VIAL in 1 CARTON (72266-252-01) / 50 mL in 1 VIALMarketed from Aug 11, 2023 |
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 — 1 mg/mL
- Dosage form
- Injection, Solution
- Route
- Intravenous
- Labeler
- FOSUN PHARMA USA INC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 207323
- Marketing start
- Listing expires
- Other FDA classes
- Platinum-containing Compounds (EXT)
- Identifiers
- Product ID 72266-252_189a1ee6-231d-7e56-e063-6394a90abc01SPL ID 189a1ee6-231d-7e56-e063-6394a90abc01SPL set ID 0219eae9-82b4-b779-e063-6394a90a311eRxCUI 309311UNII Q20Q21Q62JUPC 0372266252012, 0372266253019
- 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
N472266025201followed by a unit qualifier and the quantityPackage 72266-0252-01. 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)
INDICATIONS AND USAGE Cisplatin Injection is indicated as therapy to be employed as follows: Metastatic Testicular Tumors In established combination therapy with other approved chemotherapeutic agents in patients with metastatic testicular tumors who have already received appropriate surgical and/or radiotherapeutic procedures. Metastatic Ovarian Tumors In established combination therapy with other approved chemotherapeutic agents in patients with metastatic ovarian tumors who have already received appropriate surgical and/or radiotherapeutic procedures. An established combination consists of cisplatin and cyclophosphamide. Cisplatin Injection, as a single agent, is indicated as secondary th…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 207323
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 | FOSUN PHARMA USA INC | 72266-253 |
| Cisplatin | Cisplatin 1 mg/mL | Injection, SolutionIntravenous | BluePoint Laboratories | 68001-608 |
| Cisplatin | Cisplatin 1 mg/mL | Injection, SolutionIntravenous | BluePoint Laboratories | 68001-609 |
| Cisplatin | Cisplatin 1 mg/mL | Injection, SolutionIntravenous | Gland Pharma Limited | 68083-162 |
| Cisplatin | Cisplatin 1 mg/mL | Injection, SolutionIntravenous | Gland Pharma Limited | 68083-163 |
| Cisplatin | Cisplatin 1 mg/mL | Injection, SolutionIntravenous | Sagent Pharmaceuticals | 25021-253 |