NDC codes

FDA NDC Directory
Product NDC (as listed)66312-110Labeler and product segments. Claims need a package NDC.
Product NDC at billing width66312-0110Add 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
66312-110-206631201102020 APPLICATOR in 1 CARTON (66312-110-20) / 1 CARTRIDGE in 1 APPLICATOR / 1.7 g in 1 CARTRIDGEMarketed from Jan 5, 2004

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)
Oraqix
Generic name (nonproprietary)
lidocaine and prilocaine
Active ingredients
Lidocaine — 25 mg/gPrilocaine — 25 mg/g
Dosage form
Gel
Route
Periodontal
Labeler
Dentsply PharmaceuticalNDC labeler code 66312
Product type
Prescription drug
Marketing category
NDA — New Drug ApplicationApplication NDA 021451
Marketing start
Listing expires
Other FDA classes
Amides (Chemical structure)Amides (Chemical structure)Local Anesthesia (Physiologic effect)Local Anesthesia (Physiologic effect)
Identifiers
Product ID 66312-110_9cea1cd7-afdc-4ff7-a3a5-6133d15c1230SPL ID 9cea1cd7-afdc-4ff7-a3a5-6133d15c1230SPL set ID b501d239-923b-48b2-82ed-6c5c253a67e2RxCUI 897114, 897117UNII 98PI200987, 046O35D44R
Pharmacologic class
Amide Local Anesthetic; Antiarrhythmic

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

N466312011020 followed by a unit qualifier and the quantity

Package 66312-0110-20. 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)

Oraqix is an amide local anesthetic indicated for adults who require localized anesthesia in periodontal pockets during scaling and/or root planing. Oraqix is an amide local anesthetic indicated for adults who require localized anesthesia in periodontal pockets during scaling and/or root planing. ( 1 )

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 66312-110

What is NDC 66312-110?
66312-110 is the product NDC for Oraqix, Lidocaine 25 mg/g; Prilocaine 25 mg/g gel, listed with the FDA by Dentsply Pharmaceutical. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Oraqix (Lidocaine and prilocaine).
What is the active ingredient?
Lidocaine, Prilocaine.
Who is the labeler?
Dentsply Pharmaceutical, NDC labeler code 66312. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Oraqix?
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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