Prescription drug · ANDA
Cisplatin NDC 63323-103
Cisplatin 1 mg/mL · Injection, Solution · Intravenous · Fresenius Kabi USA, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63323-103-51 | 6332301035163323010351 | 1 VIAL in 1 CARTON (63323-103-51) / 50 mL in 1 VIALMarketed from Sep 5, 2000 | |
| 63323-103-64 | 6332301036463323010364 | 1 VIAL in 1 CARTON (63323-103-64) / 200 mL in 1 VIALMarketed from Sep 5, 2000 | |
| 63323-103-65 | 6332301036563323010365 | 1 VIAL in 1 CARTON (63323-103-65) / 100 mL in 1 VIALMarketed from Sep 5, 2000 |
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
- Fresenius Kabi USA, LLCNDC labeler code 63323
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 074735
- Marketing start
- Listing expires
- Other FDA classes
- Platinum-containing Compounds (EXT)
- Identifiers
- Product ID 63323-103_24604fc6-875c-4f70-973a-9cca93f9a7a7SPL ID 24604fc6-875c-4f70-973a-9cca93f9a7a7SPL set ID de6302d5-85f0-4116-a709-57826c2c84feRxCUI 309311UNII 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
N463323010351followed by a unit qualifier and the quantityPackage 63323-0103-51. 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 t…
Excerpt only. Read the full label for complete information.
About NDC 63323-103
- What is NDC 63323-103?
- 63323-103 is the product NDC for Cisplatin, Cisplatin 1 mg/mL injection, solution, listed with the FDA by Fresenius Kabi USA, LLC. It has 3 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Cisplatin.
- What is the active ingredient?
- Cisplatin.
- 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 Cisplatin?
- 18 other product NDCs are listed under this name. See all Cisplatin NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Cisplatin products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| CISplatin | Cisplatin 1 mg/mL | Injection, SolutionIntravenous | Apotex Corp. | 60505-6279 | 60505-6279-00 |
| Cisplatin | Cisplatin 1 mg/mL | Injection, SolutionIntravenous | BluePoint Laboratories | 68001-608 | 68001-0608-24 |
| Cisplatin | Cisplatin 1 mg/mL | Injection, SolutionIntravenous | BluePoint Laboratories | 68001-609 | 68001-0609-33 |
| Cisplatin | Cisplatin 1 mg/mL | Injection, SolutionIntravenous | FOSUN PHARMA USA INC | 72266-252 | 72266-0252-01 |
| Cisplatin | Cisplatin 1 mg/mL | Injection, SolutionIntravenous | FOSUN PHARMA USA INC | 72266-253 | 72266-0253-01 |
| Cisplatin | Cisplatin 1 mg/mL | Injection, SolutionIntravenous | Sagent Pharmaceuticals | 25021-253 | 25021-0253-5025021-0253-51 |
| Cisplatin | Cisplatin 50 mg/1 | Injection, Powder, Lyophilized, For solutionIntravenous | WG Critical Care, LLC | 44567-530 | 44567-0530-01 |
| Cisplatin | Cisplatin 1 mg/mL | Injection, SolutionIntravenous | Gland Pharma Limited | 68083-162 | 68083-0162-01 |
| Cisplatin | Cisplatin 1 mg/mL | Injection, SolutionIntravenous | Gland Pharma Limited | 68083-163 | 68083-0163-01 |
| Cisplatin | Cisplatin 1 mg/mL | InjectionIntravenous | Accord Healthcare Inc. | 16729-288 | 16729-0288-1116729-0288-38 |