Prescription drug · ANDA
CISplatin NDC 0143-9504
Cisplatin 1 mg/mL · Injection · Intravenous · Hikma Pharmaceuticals USA Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0143-9504-01 | 0014395040100143950401 | 1 VIAL, MULTI-DOSE in 1 CARTON (0143-9504-01) / 50 mL in 1 VIAL, MULTI-DOSEMarketed from Nov 7, 2000 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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
- Route
- Intravenous
- Labeler
- Hikma Pharmaceuticals USA Inc.NDC labeler code 0143
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 075036
- Marketing start
- Listing expires
- Other FDA classes
- Platinum-containing Compounds (EXT)
- Identifiers
- Product ID 0143-9504_b463892e-6ca3-4c57-ae72-bdd3a7370a08SPL ID b463892e-6ca3-4c57-ae72-bdd3a7370a08SPL set ID 76aea034-6d58-4390-a164-36aa09c1f101RxCUI 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
N400143950401followed by a unit qualifier and the quantityPackage 00143-9504-01. 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 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 Injection and cyclophosphamide. Cisplatin Injection, as a single agent, is indicated as secondary th…
Excerpt only. Read the full label for complete information.
About NDC 0143-9504
- What is NDC 0143-9504?
- 0143-9504 is the product NDC for CISplatin, Cisplatin 1 mg/mL injection, listed with the FDA by Hikma Pharmaceuticals USA Inc.. It has 1 package NDC, 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?
- Hikma Pharmaceuticals USA Inc., NDC labeler code 0143. 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 |
Other NDCs under ANDA 075036
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 | InjectionIntravenous | Hikma Pharmaceuticals USA Inc. | 0143-9505 |