Prescription drug · NDA
Nithiodote (Sodium nitrite and sodium thiosulfate) NDC 60267-812
Kit · Hope Pharmaceuticals
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 60267-812-00 | 60267081200 | 1 KIT in 1 CARTON (60267-812-00) * 10 mL in 1 VIAL, SINGLE-USE (60267-311-10) * 50 mL in 1 VIAL, SINGLE-DOSE (60267-705-50)Marketed from Jan 14, 2011 |
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)
- Nithiodote
- Generic name (nonproprietary)
- sodium nitrite and sodium thiosulfate
- Dosage form
- Kit
- Labeler
- Hope PharmaceuticalsNDC labeler code 60267
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 201444
- Marketing start
- Listing expires
- Identifiers
- Product ID 60267-812_74809468-0182-485a-bf62-e09489756a36SPL ID 74809468-0182-485a-bf62-e09489756a36SPL set ID ff4941b3-9901-4aab-adcf-c5327bede34eRxCUI 237832, 253010, 1086835, 1086836
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.
- NDC on a medical claim
N460267081200followed by a unit qualifier and the quantityPackage 60267-0812-00. 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)
NITHIODOTE is indicated for the treatment of acute cyanide poisoning that is judged to be serious or life-threatening. When the diagnosis of cyanide poisoning is uncertain, carefully weigh the potentially life-threatening risks associated with NITHIODOTE against the potential benefits, especially if the patient is not in extremis. NITHIODOTE, an antidote, is indicated for the treatment of acute cyanide poisoning that is judged to be serious or life-threatening. ( 1 ) Use with caution if the diagnosis of cyanide poisoning is uncertain. ( 1 )
Excerpt only. Read the full label for complete information.
About NDC 60267-812
- What is NDC 60267-812?
- 60267-812 is the product NDC for Nithiodote kit, listed with the FDA by Hope Pharmaceuticals. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Nithiodote (Sodium Nitrite and Sodium Thiosulfate).
- Who is the labeler?
- Hope Pharmaceuticals, NDC labeler code 60267. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Nithiodote?
- 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.