Prescription drug · NDA
Nesacaine (Chloroprocaine hydrochloride) NDC 63323-476
Chloroprocaine hydrochloride 20 mg/mL · Injection, Solution · Infiltration, Perineural · Fresenius Kabi USA, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63323-476-37 | 63323047637 | 25 VIAL, MULTI-DOSE in 1 TRAY (63323-476-37) / 30 mL in 1 VIAL, MULTI-DOSE (63323-476-01)Marketed from Oct 14, 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)
- Nesacaine
- Generic name (nonproprietary)
- chloroprocaine hydrochloride
- Active ingredients
- Chloroprocaine hydrochloride — 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 009435
- Marketing start
- Listing expires
- Other FDA classes
- Esters (Chemical structure)Local Anesthesia (Physiologic effect)
- Identifiers
- Product ID 63323-476_46570679-3557-4250-bb21-b406097e106dSPL ID 46570679-3557-4250-bb21-b406097e106dSPL set ID a844e68a-1462-40e4-be5e-f56214906eb9RxCUI 992801, 992803, 992805, 992807, 992809, 992811, 1794184, 1794186UNII LT7Z1YW11HUPC 0363323475017, 0363323478018, 0363323477011, 0363323476014
- Pharmacologic class
- Ester Local Anesthetic
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
N463323047637followed by a unit qualifier and the quantityPackage 63323-0476-37. 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 Nesacaine 1% and 2% Injections, in multidose vials with methylparaben as preservative, are indicated for the production of local anesthesia by infiltration and peripheral nerve block. They are not to be used for lumbar or caudal epidural anesthesia. Nesacaine-MPF 2% and 3% Injections, in single dose vials without preservative and without EDTA, are indicated for the production of local anesthesia by infiltration, peripheral and central nerve block, including lumbar and caudal epidural blocks. Nesacaine and Nesacaine-MPF Injections are not to be used for subarachnoid administration.
Excerpt only. Read the full label for complete information.
About NDC 63323-476
- What is NDC 63323-476?
- 63323-476 is the product NDC for Nesacaine (chloroprocaine hydrochloride), Chloroprocaine hydrochloride 20 mg/mL injection, solution, listed with the FDA by Fresenius Kabi USA, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Nesacaine (Chloroprocaine hydrochloride).
- What is the active ingredient?
- Chloroprocaine 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 Nesacaine?
- 1 other product NDC are listed under this name. See all Nesacaine NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Nesacaine products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Nesacainechloroprocaine hydrochloride | Chloroprocaine hydrochloride 10 mg/mL | Injection, SolutionInfiltration, Perineural | Fresenius Kabi USA, LLC | 63323-475 | 63323-0475-37 |
Other NDCs under NDA 009435
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 |
|---|---|---|---|---|
| (Chloroprocaine Hci | Chloroprocaine hydrochloride 10 mg/mL | Injection, SolutionInfiltration, Perineural | HF Acquisition Co LLC, DBA HealthFirst | 51662-1407 |
| Chloroprocaine Hci | Chloroprocaine hydrochloride 20 mg/mL | Injection, SolutionEpidural, Infiltration, Intracaudal, Perineural | HF Acquisition Co LLC, DBA HealthFirst | 51662-1408 |
| Nesacainechloroprocaine hydrochloride | Chloroprocaine hydrochloride 10 mg/mL | Injection, SolutionInfiltration, Perineural | Fresenius Kabi USA, LLC | 63323-475 |
| Nesacaine MPFchloroprocaine hydrochloride | Chloroprocaine hydrochloride 30 mg/mL | Injection, SolutionEpidural, Infiltration, Intracaudal, Perineural | Fresenius Kabi USA, LLC | 63323-478 |
| Nesacaine MPFchloroprocaine hydrochloride | Chloroprocaine hydrochloride 20 mg/mL | Injection, SolutionEpidural, Infiltration, Intracaudal, Perineural | Fresenius Kabi USA, LLC | 63323-477 |
| Chloroprocaine Hci | Chloroprocaine hydrochloride 20 mg/mL | Injection, SolutionInfiltration, Perineural | HF Acquisition Co LLC, DBA HealthFirst | 51662-1401 |