Prescription drug · ANDA
Lidocaine Hydrochloride NDC 76329-6300
Lidocaine hydrochloride 40 mg/mL · Solution · Topical · International Medication Systems, Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 76329-6300-5 | 7632963000576329630005 | 25 VIAL in 1 CARTON (76329-6300-5) / 4 mL in 1 VIALMarketed from Jun 19, 2012 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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 Hydrochloride
- Generic name (nonproprietary)
- lidocaine hydrochloride
- Active ingredients
- Lidocaine hydrochloride — 40 mg/mL
- Dosage form
- Solution
- Route
- Topical
- Labeler
- International Medication Systems, LimitedNDC labeler code 76329
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 086364
- Marketing start
- Listing expires
- Other FDA classes
- Amides (Chemical structure)Local Anesthesia (Physiologic effect)
- Identifiers
- Product ID 76329-6300_8e30c3dd-67a2-4973-9325-1765b95c047dSPL ID 8e30c3dd-67a2-4973-9325-1765b95c047dSPL set ID 2c48cfac-81eb-4a81-8590-bc94574dd4c3RxCUI 1010878UNII V13007Z41A
- 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 HCPCS code in Med-Code's directory. Topical products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N476329630005followed by a unit qualifier and the quantityPackage 76329-6300-05. 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 HCl Topical Solution, 4% is indicated for the production of topical anesthesia of the mucous membranes of the respiratory tract.
Excerpt only. Read the full label for complete information.
About NDC 76329-6300
- What is NDC 76329-6300?
- 76329-6300 is the product NDC for Lidocaine Hydrochloride, Lidocaine hydrochloride 40 mg/mL solution, listed with the FDA by International Medication Systems, Limited. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Lidocaine Hydrochloride.
- What is the active ingredient?
- Lidocaine hydrochloride.
- Who is the labeler?
- International Medication Systems, Limited, NDC labeler code 76329. 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 Hydrochloride?
- 191 other product NDCs are listed under this name. See all Lidocaine Hydrochloride NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Lidocaine Hydrochloride 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 Hydrochloride | Lidocaine hydrochloride 20 mg/mL | Injection, SolutionEpidural, Infiltration, Intracaudal, Perineural | Sandoz Inc. | 0781-3539 | 00781-3539-3500781-3539-96 |
| Lidocaine Hydrochloride | Lidocaine hydrochloride 10 mg/mL | Injection, SolutionEpidural, Infiltration, Intracaudal, Perineural | Sandoz Inc. | 0781-3537 | 00781-3537-2500781-3537-3500781-3537-96 |
| Lidocaine Hydrochloride | Lidocaine hydrochloride 20 mg/mL | SolutionOral | Major Pharmaceuticals | 0904-7644 | 00904-7644-87 |
| Lidocaine Hydrochloride | Lidocaine 5 g/100g | CreamTopical | YYBA CORP | 73581-120 | 73581-0120-0173581-0120-0273581-0120-06 |
| Lidocaine Hydrochloride | Lidocaine hydrochloride anhydrous 10 mg/mL | Injection, SolutionInfiltration, Perineural | Henry Schein, Inc. | 0404-9763 | 00404-9763-20 |
| lidocaine hydrochloride | Lidocaine hydrochloride 10 mg/mL | Injection, SolutionEpidural, Infiltration, Intracaudal, Perineural | Avenacy, LLC | 83634-653 | 83634-0653-0283634-0653-0583634-0653-30 |
| Lidocaine Hydrochloride | Lidocaine hydrochloride 10 mg/mL | SolutionIntravenous | Brookfield Pharmaceuticals, LLC. | 71351-026 | 71351-0026-25 |
| Lidocaine Hydrochloride | Lidocaine hydrochloride 20 mg/mL | SolutionIntravenous | Brookfield Pharmaceuticals, LLC. | 71351-027 | 71351-0027-25 |
| Lidocaine Hydrochloride | Lidocaine hydrochloride 10 mg/mL | Injection, SolutionEpidural, Infiltration, Intracaudal, Perineural | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 23155-940 | 23155-0940-41 |
| Lidocaine hydrochloride | Lidocaine hydrochloride 20 mg/mL | SolutionOral, Topical | American Health Packaging | 60687-870 | 60687-0870-64 |
Other NDCs under ANDA 086364
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 HCl | Lidocaine hydrochloride 40 mg/mL | SolutionTopical | HF Acquisition Co LLC, DBA HealthFirst | 51662-1553 |