Prescription drug · NDA
Pedmark (Sodium thiosulfate) NDC 73077-010
Sodium thiosulfate 12.5 g/100mL · Injection, Solution · Intravenous · Fennec Pharmaceuticals Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 73077-010-01 | 73077001001 | 1 VIAL, SINGLE-DOSE in 1 BOX, UNIT-DOSE (73077-010-01) / 100 mL in 1 VIAL, SINGLE-DOSEMarketed from Oct 3, 2022 |
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)
- Pedmark
- Generic name (nonproprietary)
- sodium thiosulfate
- Active ingredients
- Sodium thiosulfate — 12.5 g/100mL
- Dosage form
- Injection, Solution
- Route
- Intravenous
- Labeler
- Fennec Pharmaceuticals Inc.NDC labeler code 73077
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 212937
- Marketing start
- Listing expires
- Identifiers
- Product ID 73077-010_889accaa-7f62-4da4-84ea-80ecfb144209SPL ID 889accaa-7f62-4da4-84ea-80ecfb144209SPL set ID f98c7076-2a7b-4fd7-ab90-eed5e9137baeRxCUI 2618749, 2618755UNII HX1032V43M
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
N473077001001followed by a unit qualifier and the quantityPackage 73077-0010-01. 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 .
Indications (excerpt from the label)
PEDMARK is indicated to reduce the risk of ototoxicity associated with cisplatin in pediatric patients 1 month of age and older with localized, non-metastatic solid tumors. Limitations of Use The safety and efficacy of PEDMARK have not been established when administered following cisplatin infusions longer than 6 hours. PEDMARK may not reduce the risk of ototoxicity when administered following longer cisplatin infusions, because irreversible ototoxicity may have already occurred. PEDMARK is indicated to reduce the risk of ototoxicity associated with cisplatin in pediatric patients 1 month of age and older with localized, non-metastatic solid tumors. ( 1 ) Limitations of Use: The safety and e…
Excerpt only. Read the full label for complete information.
About NDC 73077-010
- What is NDC 73077-010?
- 73077-010 is the product NDC for Pedmark (sodium thiosulfate), Sodium thiosulfate 12.5 g/100mL injection, solution, listed with the FDA by Fennec Pharmaceuticals Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Pedmark (Sodium thiosulfate).
- What is the active ingredient?
- Sodium thiosulfate.
- Who is the labeler?
- Fennec Pharmaceuticals Inc., NDC labeler code 73077. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Pedmark?
- None: this is the only finished product listed under this name.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.