Prescription drug · ANDA
Lidocaine (Lidocaine hydrochloride) NDC 63323-201
Lidocaine hydrochloride 10 mg/mL · Injection, Solution · Infiltration, Perineural · Fresenius Kabi USA, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63323-201-02 | 6332302010263323020102 | 25 VIAL in 1 TRAY (63323-201-02) / 2 mL in 1 VIAL (63323-201-01)Marketed from May 27, 2010 | |
| 63323-201-10 | 6332302011063323020110 | 25 VIAL in 1 TRAY (63323-201-10) / 10 mL in 1 VIAL (63323-201-03)Marketed from May 27, 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)
- Lidocaine
- Generic name (nonproprietary)
- lidocaine hydrochloride
- Active ingredients
- Lidocaine hydrochloride — 10 mg/mL
- Dosage form
- Injection, Solution
- Route
- Infiltration, Perineural
- Labeler
- Fresenius Kabi USA, LLCNDC labeler code 63323
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 088586
- Marketing start
- Listing expires
- Other FDA classes
- Amides (Chemical structure)Local Anesthesia (Physiologic effect)
- Identifiers
- Product ID 63323-201_d19c26f4-1214-40f7-9680-43c885613306SPL ID d19c26f4-1214-40f7-9680-43c885613306SPL set ID cddb2b22-fce3-8967-6e54-dca3df5ac4b3RxCUI 1010033, 1737757UNII V13007Z41AUPC 0363323202019, 0363323201036, 0363323201012
- 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
N463323020102followed by a unit qualifier and the quantityPackage 63323-0201-02. 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 Lidocaine Hydrochloride Injection, USP is indicated for the production of local anesthesia, by infiltration techniques, such as percutaneous injection, and by peripheral nerve block techniques, such as brachial plexus and inter-costal, 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 63323-201
- What is NDC 63323-201?
- 63323-201 is the product NDC for Lidocaine (lidocaine hydrochloride), Lidocaine hydrochloride 10 mg/mL injection, solution, listed with the FDA by Fresenius Kabi USA, LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Lidocaine (Lidocaine hydrochloride).
- What is the active ingredient?
- Lidocaine hydrochloride.
- 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 Lidocaine?
- 157 other product NDCs are listed under this name. See all Lidocaine NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Lidocaine products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Lidocaine | Lidocaine 50 mg/g | OintmentTopical | Direct_Rx | 72189-692 | 72189-0692-50 |
| Lidocaine | Lidocaine 50 mg/g | OintmentTopical | Preferred Pharmaceuticals Inc. | 68788-4195 | 68788-4195-05 |
| Lidocaine | Lidocaine 50 mg/g | PatchTopical | Ascend Laboratories, LLC | 67877-767 | 67877-0767-30 |
| Lidocaine | Lidocaine 80 mg/mL | SprayTopical | YYBA CORP | 73581-900 | 73581-0900-01 |
| Lidocaine | Lidocaine 50 mg/g | OintmentTopical | Advanced Rx of Tennessee, LLC | 80425-0594 | 80425-0594-01 |
| Lidocainelidocaine hydrochloride | Lidocaine hydrochloride 20 mg/mL | JellyTopical | Sentiss Pharmaceuticals LLC | 70244-039 | 70244-0039-0170244-0039-02 |
| Lidocaine | Lidocaine 100 kg/100kg | GranuleTopical | Shaanxi Shuvita Biotech Co., Ltd | 87879-002 | 87879-0002-02 |
| Lidocainelidicaine | Lidocaine 50 mg/g | OintmentTopical | Encube Ethicals, Inc. | 21922-107 | 21922-0107-1321922-0107-61 |
| Lidocaine | Lidocaine hydrochloride 50 mg/mL | GelTopical | YYBA Corp | 73581-115 | 73581-0115-03 |
| Lidocaine | Lidocaine 5 g/100mL | CreamTopical | YYBA Corp | 73581-022 | 73581-0022-06 |
Other NDCs under ANDA 088586
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 |
|---|---|---|---|---|
| Lidocainelidocaine hydrochloride | Lidocaine hydrochloride 20 mg/mL | Injection, SolutionInfiltration, Perineural | Fresenius Kabi USA, LLC | 63323-202 |
| Lidocainelidocaine hydrochloride | Lidocaine hydrochloride 10 mg/mL | Injection, SolutionInfiltration, Perineural | Sportpharm LLC | 85766-063 |