Prescription drug · NDA
Xylocaine (Lidocaine hydrochloride) NDC 63323-486
Lidocaine hydrochloride anhydrous 20 mg/mL · Injection, Solution · Infiltration, Perineural · Fresenius Kabi USA, LLC
NDC codes
FDA NDC DirectoryProduct NDC (as listed)63323-486Labeler and product segments. Claims need a package NDC.
Product NDC at billing width63323-0486Add the package segment from the table below.
| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63323-486-17 | 63323048617 | 25 VIAL, MULTI-DOSE in 1 TRAY (63323-486-17) / 10 mL in 1 VIAL, MULTI-DOSE (63323-486-01)Marketed from Aug 12, 2010 | |
| 63323-486-27 | 63323048627 | 25 VIAL, MULTI-DOSE in 1 TRAY (63323-486-27) / 20 mL in 1 VIAL, MULTI-DOSE (63323-486-02)Marketed from Aug 12, 2010 | |
| 63323-486-57 | 63323048657 | 25 VIAL, MULTI-DOSE in 1 TRAY (63323-486-57) / 50 mL in 1 VIAL, MULTI-DOSE (63323-486-05)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
- Active ingredients
- Lidocaine hydrochloride anhydrous — 20 mg/mL
- Dosage form
- Injection, Solution
- Route
- Infiltration, Perineural
- Labeler
- Fresenius Kabi USA, LLCNDC labeler code 63323
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 006488
- Marketing start
- Listing expires
- Other FDA classes
- Amides (Chemical structure)Local Anesthesia (Physiologic effect)
- Identifiers
- Product ID 63323-486_ea480a68-5927-4278-9deb-2956961da428SPL ID ea480a68-5927-4278-9deb-2956961da428SPL set ID ba082c2f-64f4-419d-9c88-74f203316e17RxCUI 1010033, 1010035, 1010671, 1010673, 1010688, 1010692, 1010745, 1010749, 1010751, 1010755, 1010759, 1010763, 1010900, 1010902, 1737343, 1737345, 1737562, 1737563, 1737566, 1737567, 1737568, 1737569, 1737570, 1737571, 1737757, 1737758, 1737761, 1737762, 1867938, 1867940, 1867943, 1867944, 1867992, 1867993, 1867996, 1867997, 1868028, 1868029UNII 30Q7KI53AK, EC2CNF7XFPUPC 0363323484576, 0363323485016, 0363323483036, 0363323487072, 0363323486013, 0363323495091, 0363323488079, 0363323489021, 0363323495046, 0363323491017, 0363323492045, 0363323492090, 0363323482015, 0363323481018
- 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
N463323048617followed by a unit qualifier and the quantityPackage 63323-0486-17. 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.
About NDC 63323-486
- What is NDC 63323-486?
- 63323-486 is the product NDC for Xylocaine (lidocaine hydrochloride), Lidocaine hydrochloride anhydrous 20 mg/mL injection, solution, listed with the FDA by Fresenius Kabi USA, LLC. It has 3 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Xylocaine (Lidocaine hydrochloride).
- What is the active ingredient?
- Lidocaine hydrochloride anhydrous.
- Who is the labeler?
- Fresenius Kabi USA, LLC, NDC labeler code 63323. 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.
Related NDCs: other Xylocaine products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Xylocainelidocaine hydrochloride,epinephrine bitartrate | Lidocaine hydrochloride anhydrous 10 mg/mL; Epinephrine bitartrate .01 mg/mL | Injection, SolutionInfiltration, Perineural | REMEDYREPACK INC. | 70518-4152 | 70518-4152-0170518-4152-02 |
| Xylocaine | Lidocaine hydrochloride anhydrous 20 mg/mL | Injection, SolutionInfiltration, Perineural | HF Acquisition Co LLC, DBA HealthFirst | 51662-1590 | 51662-1590-03 |
| Xylocaine | Lidocaine hydrochloride anhydrous 10 mg/mL | Injection, SolutionInfiltration, Perineural | HF Acquisition Co LLC, DBA HealthFirst | 51662-1591 | 51662-1591-03 |
| Xylocainelidocaine hcl | Lidocaine hydrochloride anhydrous 20 mg/mL | Injection, SolutionInfiltration, Perineural | Henry Schein, Inc. | 0404-9974 | 00404-9974-2000404-9974-50 |
| Xylocainelidocaine hydrochloride and epinephrine | Lidocaine hydrochloride anhydrous 20 mg/mL; Epinephrine bitartrate .005 mg/mL | Injection, SolutionEpidural, Infiltration, Intracaudal, Perineural | Henry Schein, Inc. | 0404-9972 | 00404-9972-20 |
| Xylocainelidocaine hydrochloride | Lidocaine hydrochloride anhydrous 10 mg/mL | Injection, SolutionInfiltration, Perineural | Henry Schein, Inc. | 0404-9973 | 00404-9973-2000404-9973-50 |
| 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 | 00404-9975-50 |
| Xylocainelidocaine hydrochloride and epinephrine | Lidocaine hydrochloride anhydrous 20 mg/mL; Epinephrine bitartrate .01 mg/mL | Injection, SolutionInfiltration, Perineural | Henry Schein, Inc. | 0404-9976 | 00404-9976-2000404-9976-50 |
| Xylocainelidocaine hydrochloride and epinephrine | Lidocaine hydrochloride anhydrous 10 mg/mL; Epinephrine bitartrate .01 mg/mL | Injection, SolutionInfiltration, Perineural | Henry Schein, Inc. | 0404-9977 | 00404-9977-2000404-9977-50 |
| Xylocainelidocaine hydrochloride,epinephrine bitartrate | Lidocaine hydrochloride anhydrous 20 mg/mL; Epinephrine bitartrate .01 mg/mL | Injection, SolutionInfiltration, Perineural | A-S Medication Solutions | 50090-6851 | 50090-6851-00 |
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 |
|---|---|---|---|---|
| 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 |
| Lidocaine Hci And Epinephrine With Epinephrine | Epinephrine bitartrate .005 mg/mL; Lidocaine hydrochloride anhydrous 20 mg/mL | Injection, SolutionEpidural, Infiltration, Intracaudal, Perineural | HF Acquisition Co LLC, DBA HealthFirst | 51662-1412 |
| XYLOCAIN (LIDOCAINE HCl )xylocaine (lidocaine hcl ) | Lidocaine hydrochloride anhydrous 10 mg/mL | Injection, SolutionInfiltration, Perineural | HF Acquisition Co LLC, DBA HealthFirst | 51662-1587 |
| Xylocainelidocaine hydrochloride and epinephrine | Lidocaine hydrochloride anhydrous 20 mg/mL; Epinephrine bitartrate .005 mg/mL | Injection, SolutionEpidural, Infiltration, Intracaudal, Perineural | Henry Schein, Inc. | 0404-9972 |
| 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 |
| 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 |
| 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 and epinephrine | Lidocaine hydrochloride anhydrous 10 mg/mL; Epinephrine bitartrate .01 mg/mL | Injection, SolutionInfiltration, Perineural | Henry Schein, Inc. | 0404-9977 |
| 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 | Lidocaine hydrochloride anhydrous 20 mg/mL | Injection, SolutionInfiltration, Perineural | HF Acquisition Co LLC, DBA HealthFirst | 51662-1590 |
| Xylocaine | Lidocaine hydrochloride anhydrous 10 mg/mL | Injection, SolutionInfiltration, Perineural | HF Acquisition Co LLC, DBA HealthFirst | 51662-1591 |
| Xylocaine | Epinephrine bitartrate .01 mg/mL; Lidocaine hydrochloride anhydrous 10 mg/mL | Injection, SolutionInfiltration, Perineural | HF Acquisition Co LLC, DBA HealthFirst | 51662-1622 |
| Xylocaine | Lidocaine hydrochloride anhydrous 10 mg/mL | Injection, SolutionInfiltration, Perineural | HF Acquisition Co LLC, DBA HealthFirst | 51662-1645 |
| Xylocainelidocaine hydrochloride,epinephrine bitartrate | Lidocaine hydrochloride anhydrous 5 mg/mL; Epinephrine bitartrate .005 mg/mL | Injection, SolutionInfiltration, Perineural | Fresenius Kabi USA, LLC | 63323-481 |
| Xylocainelidocaine hydrochloride,epinephrine bitartrate | Lidocaine hydrochloride anhydrous 10 mg/mL; Epinephrine bitartrate .01 mg/mL | Injection, SolutionInfiltration, Perineural | Fresenius Kabi USA, LLC | 63323-482 |
| Xylocainelidocaine hydrochloride,epinephrine bitartrate | Lidocaine hydrochloride anhydrous 20 mg/mL; Epinephrine bitartrate .01 mg/mL | Injection, SolutionInfiltration, Perineural | Fresenius Kabi USA, LLC | 63323-483 |
| Xylocainelidocaine hydrochloride | Lidocaine hydrochloride anhydrous 5 mg/mL | Injection, SolutionInfiltration, Perineural | Fresenius Kabi USA, LLC | 63323-484 |
| Xylocainelidocaine hydrochloride | Lidocaine hydrochloride anhydrous 10 mg/mL | Injection, SolutionInfiltration, Perineural | Fresenius Kabi USA, LLC | 63323-485 |
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