NDC codes

FDA NDC Directory
Product NDC (as listed)66312-181Labeler and product segments. Claims need a package NDC.
Product NDC at billing width66312-0181Add 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
66312-181-16663120181166631201811650 CARTRIDGE in 1 CARTON (66312-181-16) / 1.7 mL in 1 CARTRIDGEMarketed from Apr 14, 2009

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)
Xylocaine
Generic name (nonproprietary)
lidocaine hydrochloride and epinephrine bitartrate
Active ingredients
Lidocaine hydrochloride — 20 mg/mLEpinephrine bitartrate — 20 ug/mL
Dosage form
Injection, Solution
Route
Submucosal
Labeler
Dentsply PharmaceuticalNDC labeler code 66312
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 088389
Marketing start
Listing expires
Other FDA classes
Adrenergic alpha-Agonists (Mechanism)Adrenergic beta-Agonists (Mechanism)Amides (Chemical structure)Catecholamines (Chemical structure)Local Anesthesia (Physiologic effect)
Identifiers
Product ID 66312-181_d14d0eb3-a481-4c68-a0cd-75aae0622fd1SPL ID d14d0eb3-a481-4c68-a0cd-75aae0622fd1SPL set ID 14b55cf9-f7cd-4bb4-a7c5-aba61abadef1RxCUI 1010768, 1293648, 1608499, 1657026UNII 30Q7KI53AK, V13007Z41A
Pharmacologic class
Amide Local Anesthetic; Antiarrhythmic; Catecholamine; alpha-Adrenergic Agonist; beta-Adrenergic Agonist

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

N466312018116 followed by a unit qualifier and the quantity

Package 66312-0181-16. 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)

INDICATIONS AND USAGE 2% Xylocaine DENTAL Solutions are indicated for the production of local anesthesia for dental procedures by nerve block or infiltration techniques. Only accepted procedures for these techniques as described in standard textbooks are recommended.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 66312-181

What is NDC 66312-181?
66312-181 is the product NDC for Xylocaine, Lidocaine hydrochloride 20 mg/mL; Epinephrine bitartrate 20 ug/mL injection, solution, 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?
Xylocaine (Lidocaine Hydrochloride and Epinephrine Bitartrate).
What is the active ingredient?
Lidocaine hydrochloride, Epinephrine bitartrate.
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 Xylocaine?
23 other product NDCs are listed under this name. See all Xylocaine NDCs.
Is there a related HCPCS / J-code?
Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Xylocaine NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Xylocainelidocaine hydrochloride,epinephrine bitartrateLidocaine hydrochloride anhydrous 10 mg/mL; Epinephrine bitartrate .01 mg/mLInjection, SolutionInfiltration, PerineuralREMEDYREPACK INC.70518-415270518-4152-0170518-4152-02
XylocaineLidocaine hydrochloride anhydrous 20 mg/mLInjection, SolutionInfiltration, PerineuralHF Acquisition Co LLC, DBA HealthFirst51662-159051662-1590-03
XylocaineLidocaine hydrochloride anhydrous 10 mg/mLInjection, SolutionInfiltration, PerineuralHF Acquisition Co LLC, DBA HealthFirst51662-159151662-1591-03
Xylocainelidocaine hclLidocaine hydrochloride anhydrous 20 mg/mLInjection, SolutionInfiltration, PerineuralHenry Schein, Inc.0404-997400404-9974-2000404-9974-50
Xylocainelidocaine hydrochloride and epinephrineLidocaine hydrochloride anhydrous 20 mg/mL; Epinephrine bitartrate .005 mg/mLInjection, SolutionEpidural, Infiltration, Intracaudal, PerineuralHenry Schein, Inc.0404-997200404-9972-20
Xylocainelidocaine hydrochlorideLidocaine hydrochloride anhydrous 10 mg/mLInjection, SolutionInfiltration, PerineuralHenry Schein, Inc.0404-997300404-9973-2000404-9973-50
Xylocainelidocaine hydrochloride, epinephrine bitartrate injection, solutionLidocaine hydrochloride anhydrous 5 mg/mL; Epinephrine bitartrate .005 mg/mLInjection, SolutionInfiltration, PerineuralHenry Schein, Inc0404-997500404-9975-50
Xylocainelidocaine hydrochloride and epinephrineLidocaine hydrochloride anhydrous 20 mg/mL; Epinephrine bitartrate .01 mg/mLInjection, SolutionInfiltration, PerineuralHenry Schein, Inc.0404-997600404-9976-2000404-9976-50
Xylocainelidocaine hydrochloride and epinephrineLidocaine hydrochloride anhydrous 10 mg/mL; Epinephrine bitartrate .01 mg/mLInjection, SolutionInfiltration, PerineuralHenry Schein, Inc.0404-997700404-9977-2000404-9977-50
Xylocainelidocaine hydrochloride,epinephrine bitartrateLidocaine hydrochloride anhydrous 20 mg/mL; Epinephrine bitartrate .01 mg/mLInjection, SolutionInfiltration, PerineuralA-S Medication Solutions50090-685150090-6851-00

All 24 Xylocaine NDCs

Other NDCs under ANDA 088389

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 088389
ProductStrengthForm · routeLabelerProduct NDC
Lidocainelidocaine hydrochloride and epinephrineLidocaine hydrochloride 20 mg/mL; Epinephrine bitartrate .02 mg/mLInjection, SolutionSubmucosalSeptodont, Inc.0362-0262
Lidocainelidocaine hydrochloride and epinephrine bitartrateLidocaine hydrochloride 20 mg/mL; Epinephrine bitartrate .02 mg/mLInjection, SolutionSubmucosalHenry Schein Inc.0404-6500
Lidocainelidocaine hydrochloride and epinephrine bitartrateLidocaine hydrochloride 20 mg/mL; Epinephrine bitartrate .02 mg/mLInjection, SolutionSubmucosalPatterson Dental50227-1020
Lidocainelidocaine hydrochloride and epinephrine bitartrateLidocaine hydrochloride 20 mg/mL; Epinephrine bitartrate .02 mg/mLInjection, SolutionSubmucosalDarby Dental Supply, LLC66467-9710
Lidocainelidocaine hydrochloride and epinephrine bitartrateLidocaine hydrochloride 20 mg/mL; Epinephrine bitartrate .02 mg/mLInjection, SolutionSubmucosalBenco Dental66975-415
Lignospan Fortelidocaine hydrochloride and epinephrineLidocaine hydrochloride 20 mg/mL; Epinephrine bitartrate .02 mg/mLInjection, SolutionSubmucosalSeptodont, Inc.0362-1096

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