Prescription drug · ANDA
Cisplatin NDC 16729-288
Cisplatin 1 mg/mL · Injection · Intravenous · Accord Healthcare Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 16729-288-11 | 1672902881116729028811 | 50 mL in 1 VIAL (16729-288-11)Marketed from Dec 13, 2016 | |
| 16729-288-38 | 1672902883816729028838 | 100 mL in 1 VIAL (16729-288-38)Marketed from Dec 13, 2016 |
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
- Route
- Intravenous
- Labeler
- Accord Healthcare Inc.NDC labeler code 16729
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 206774
- Marketing start
- Listing expires
- Other FDA classes
- Platinum-containing Compounds (EXT)
- Identifiers
- Product ID 16729-288_2860827e-1817-2b85-e063-6394a90a127eSPL ID 2860827e-1817-2b85-e063-6394a90a127eSPL set ID b2b029f5-0d7e-4e7f-accc-b722aec34c68RxCUI 309311UNII Q20Q21Q62JUPC 0316729288385, 0316729288118
- 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
N416729028811followed by a unit qualifier and the quantityPackage 16729-0288-11. 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 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 injection is indicated for the treatment of advanced testicular cancer. 1.2 Advanced Ovarian Cancer Cisplatin injection is indicated for the treatment of advanced ovarian cancer. 1.3 Advanced Bladder Cancer Cisplatin injection is indicated for the treatment of advanced bladder cancer.
Excerpt only. Read the full label for complete information.
About NDC 16729-288
- What is NDC 16729-288?
- 16729-288 is the product NDC for Cisplatin, Cisplatin 1 mg/mL injection, listed with the FDA by Accord Healthcare Inc.. It has 2 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?
- Accord Healthcare Inc., NDC labeler code 16729. 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 | BluePoint Laboratories | 68001-283 | 68001-0283-2768001-0283-32 |
Other NDCs under ANDA 206774
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 | BluePoint Laboratories | 68001-283 |