What is NDC 0362-0101?

0362-0101 is the product NDC for Oraverse (phentolamine mesylate), Phentolamine mesylate .235 mg/mL injection, solution, listed with the FDA by Septodont, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.

What drug is associated with this NDC?

Oraverse (Phentolamine Mesylate).

Septodont, Inc., NDC labeler code 0362. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Oraverse?

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.

Oraverse NDC 0362-0101 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)0362-0101Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00362-0101Add 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 NDC	11-digit (billing)	Package	Copy
0362-0101-10	0036201011000362010110	10 CARTRIDGE in 1 CARTON (0362-0101-10) / 1.7 mL in 1 CARTRIDGEMarketed from Jun 1, 2011

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): Oraverse
Generic name (nonproprietary): phentolamine mesylate
Active ingredients: Phentolamine mesylate — .235 mg/mL
Dosage form: Injection, Solution
Route: Submucosal
Labeler: Septodont, Inc.NDC labeler code 0362
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 022159
Marketing start: Jun 1, 2011
Listing expires: Dec 31, 2027
Other FDA classes: Adrenergic alpha-Antagonists (Mechanism)
Identifiers: Product ID 0362-0101_f0465990-acce-46dc-9290-344dab1e4f2fSPL ID f0465990-acce-46dc-9290-344dab1e4f2fSPL set ID 4025cf98-ea87-4531-b0fc-6283c84f63f3RxCUI 1361019, 1361021UNII Y7543E5K9T
Pharmacologic class: alpha-Adrenergic Blocker

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

N400362010110 followed by a unit qualifier and the quantity

Package 00362-0101-10. 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 Dec 5, 2018.

Indications (excerpt from the label)

1. INDICATONS AND USAGE OraVerse an alpha adrenergic blocker, is indicated for adult and pediatric patients ages 3 years and older for the reversal of soft-tissue anesthesia, i.e., anesthesia of the lip and tongue, and the associated functional deficits resulting from an intraoral submucosal injection of a local anesthetic containing a vasoconstrictor. OraVerse, an alpha adrenergic blocker, is indicated for adult and pediatric patients ages 3 years and older for the reversal of soft-tissue anesthesia, i.e., anesthesia of the lip and tongue, and the associated functional deficits resulting from an intraoral submucosal injection of a local anesthetic containing a vasoconstrictor. ( 1 )

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0362-0101

What is NDC 0362-0101?: 0362-0101 is the product NDC for Oraverse (phentolamine mesylate), Phentolamine mesylate .235 mg/mL injection, solution, listed with the FDA by Septodont, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Oraverse (Phentolamine Mesylate).
What is the active ingredient?: Phentolamine mesylate.
Who is the labeler?: Septodont, Inc., NDC labeler code 0362. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Oraverse?: 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.

Oraverse (Phentolamine mesylate) NDC 0362-0101