NDC codes

FDA NDC Directory
Product NDC (as listed)60267-812Labeler and product segments. Claims need a package NDC.
Product NDC at billing width60267-0812Add the package segment from the table below.
Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC11-digit (billing)PackageCopy
60267-812-00602670812001 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

N460267081200 followed by a unit qualifier and the quantity

Package 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.

Full label on DailyMed (opens in a new tab)

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.

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