Prescription drug · NDA
Xylocaine NDC 63323-482
lidocaine hydrochloride,epinephrine bitartrate · Lidocaine hydrochloride anhydrous 10 mg/mL; Epinephrine bitartrate .01 mg/mL · Injection, Solution · Infiltration, Perineural · Fresenius Kabi USA, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63323-482-26 | 63323048226 | 25 VIAL, MULTI-DOSE in 1 TRAY (63323-482-26) / 20 mL in 1 VIAL, MULTI-DOSE (63323-482-41)Marketed from Aug 12, 2010 |
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,epinephrine bitartrate
- Active ingredients
- Lidocaine hydrochloride anhydrous — 10 mg/mLEpinephrine bitartrate — .01 mg/mL
- Dosage form
- Injection, Solution
- Route
- Infiltration, Perineural
- Labeler
- Fresenius Kabi USA, LLC
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 006488
- 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 63323-482_0ff12fe1-0ad7-4ae0-83bf-30f11e3adb33SPL ID 0ff12fe1-0ad7-4ae0-83bf-30f11e3adb33SPL set ID 4dd52202-8eef-4136-92dd-ada573b7cf74RxCUI 1010033, 1010035, 1010671, 1010673, 1010751, 1010755, 1737562, 1737563, 1737566, 1737567, 1737568, 1737569, 1737570, 1737571, 1737757, 1737758, 1737761, 1737762UNII 30Q7KI53AK, EC2CNF7XFPUPC 0363323486419, 0363323495411, 0363323492434, 0363323482411, 0363323485412, 0363323492458, 0363323492410
- 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
N463323048226followed by a unit qualifier and the quantityPackage 63323-0482-26. 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: Xylocaine (lidocaine HCl) Injections are indicated for production of local or regional anesthesia by infiltration techniques such as percutaneous injection and intravenous regional anesthesia by peripheral nerve block techniques such as brachial plexus and intercostal and by central neural techniques such as lumbar and caudal epidural blocks, when the accepted procedures for these techniques as described in standard textbooks are observed.
Excerpt only. Read the full label for complete information.
Other NDCs under NDA 006488
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Xylocainelidocaine hydrochloride | Lidocaine hydrochloride anhydrous 20 mg/mL | Injection, SolutionInfiltration, Perineural | Sportpharm LLC | 85766-018 |
| Xylocainelidocaine hydrochloride and epinephrine | Lidocaine hydrochloride anhydrous 20 mg/mL; Epinephrine bitartrate .01 mg/mL | Injection, SolutionInfiltration, Perineural | Henry Schein, Inc. | 0404-9976 |
| Xylocainelidocaine hydrochloride | Lidocaine hydrochloride anhydrous 10 mg/mL | Injection, SolutionInfiltration, Perineural | Henry Schein, Inc. | 0404-9973 |
| Xylocainelidocaine hcl | Lidocaine hydrochloride anhydrous 20 mg/mL | Injection, SolutionInfiltration, Perineural | Henry Schein, Inc. | 0404-9974 |
| Xylocaine MPFlidocaine hydrochloride | Lidocaine hydrochloride anhydrous 20 mg/mL | Injection, SolutionEpidural, Infiltration, Intracaudal, Perineural | Sportpharm LLC | 85766-256 |
| Xylocainelidocaine hydrochloride, epinephrine bitartrate injection, solution | Lidocaine hydrochloride anhydrous 5 mg/mL; Epinephrine bitartrate .005 mg/mL | Injection, SolutionInfiltration, Perineural | Henry Schein, Inc | 0404-9975 |
| Lidocaine Hci And Epinephrine | Lidocaine hydrochloride anhydrous 20 mg/mL; Epinephrine bitartrate .01 mg/mL | Injection, SolutionInfiltration, Perineural | HF Acquisition Co LLC, DBA HealthFirst | 51662-1505 |
| Lidocaine Hci And Epinephrine | Lidocaine hydrochloride anhydrous 20 mg/mL; Epinephrine bitartrate .01 mg/mL | Injection, SolutionInfiltration, Perineural | HF Acquisition Co LLC, DBA HealthFirst | 51662-1506 |
| Xylocainelidocaine hydrochloride and epinephrine | Lidocaine hydrochloride anhydrous 10 mg/mL; Epinephrine bitartrate .01 mg/mL | Injection, SolutionInfiltration, Perineural | Henry Schein, Inc. | 0404-9977 |
| Xylocaine-Mpf With Epi | Epinephrine bitartrate .005 mg/mL; Lidocaine hydrochloride anhydrous 20 mg/mL | Injection, SolutionEpidural, Infiltration, Intracaudal, Perineural | HF Acquisition Co LLC, DBA HealthFirst | 51662-1550 |
| Xylocaine | Lidocaine hydrochloride anhydrous 20 mg/mL | Injection, SolutionInfiltration, Perineural | HF Acquisition Co LLC, DBA HealthFirst | 51662-1590 |
| XYLOCAIN (LIDOCAINE HCl )xylocaine (lidocaine hcl ) | Lidocaine hydrochloride anhydrous 10 mg/mL | Injection, SolutionInfiltration, Perineural | HF Acquisition Co LLC, DBA HealthFirst | 51662-1587 |
| Xylocaine | Lidocaine hydrochloride anhydrous 10 mg/mL | Injection, SolutionInfiltration, Perineural | HF Acquisition Co LLC, DBA HealthFirst | 51662-1591 |
| Xylocainelidocaine hydrochloride | Lidocaine hydrochloride anhydrous 20 mg/mL | Injection, SolutionInfiltration, Perineural | Asclemed USA, Inc. | 76420-369 |
| XYLOCAINE- MPF (LIDOCAINE HCl )lidocaine hcl | Lidocaine hydrochloride anhydrous 20 mg/mL | Injection, SolutionEpidural, Infiltration, Intracaudal, Perineural | HF Acquisition Co LLC, DBA HealthFirst | 51662-1604 |
| Xylocainelidocaine hydrochloride,epinephrine bitartrate | Lidocaine hydrochloride anhydrous 20 mg/mL; Epinephrine bitartrate .01 mg/mL | Injection, SolutionInfiltration, Perineural | A-S Medication Solutions | 50090-6851 |
| Xylocaine | Epinephrine bitartrate .01 mg/mL; Lidocaine hydrochloride anhydrous 10 mg/mL | Injection, SolutionInfiltration, Perineural | HF Acquisition Co LLC, DBA HealthFirst | 51662-1622 |
| Xylocaine Mpf | Lidocaine hydrochloride anhydrous 10 mg/mL | Injection, SolutionEpidural, Infiltration, Intracaudal, Perineural | HF Acquisition Co LLC, DBA HealthFirst | 51662-1644 |
| Xylocaine | Lidocaine hydrochloride anhydrous 10 mg/mL | Injection, SolutionInfiltration, Perineural | HF Acquisition Co LLC, DBA HealthFirst | 51662-1645 |
| Xylocaine Mpflidocaine hydrochloride | Lidocaine hydrochloride anhydrous 5 mg/mL | Injection, SolutionInfiltration | HF Acquisition Co LLC, DBA HealthFirst | 51662-1653 |
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