Prescription drug · ANDA
Lidocaine Hydrochloride NDC 0527-6004
Lidocaine hydrochloride anhydrous 40 mg/mL · Solution · Oral · Lannett Company, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0527-6004-80 | 00527600480 | 1 BOTTLE in 1 CARTON (0527-6004-80) / 50 mL in 1 BOTTLEMarketed from Feb 27, 2007 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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 Hydrochloride
- Generic name (nonproprietary)
- lidocaine hydrochloride
- Active ingredients
- Lidocaine hydrochloride anhydrous — 40 mg/mL
- Dosage form
- Solution
- Route
- Oral
- Labeler
- Lannett Company, Inc.NDC labeler code 0527
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 040710
- Marketing start
- Listing expires
- Other FDA classes
- Amides (Chemical structure)Local Anesthesia (Physiologic effect)
- Identifiers
- Product ID 0527-6004_94508c6a-c451-46de-850c-a63f5152df01SPL ID 94508c6a-c451-46de-850c-a63f5152df01SPL set ID c3353e08-2a8c-4ace-ba89-114f7131b8deRxCUI 1010878UNII EC2CNF7XFPUPC 0305276004807
- 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. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N400527600480followed by a unit qualifier and the quantityPackage 00527-6004-80. 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 Topical Solution USP, 4% is indicated for the production of topical anesthesia of accessible mucous membranes of the oral and nasal cavities and proximal portions of the digestive tract.
Excerpt only. Read the full label for complete information.
About NDC 0527-6004
- What is NDC 0527-6004?
- 0527-6004 is the product NDC for Lidocaine Hydrochloride, Lidocaine hydrochloride anhydrous 40 mg/mL solution, listed with the FDA by Lannett Company, Inc.. 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 anhydrous.
- Who is the labeler?
- Lannett Company, Inc., NDC labeler code 0527. 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?
- 179 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 | 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 |
| Lidocaine Hydrochloride | Lidocaine hydrochloride 20 mg/mL | SolutionOral, Topical | Aurobindo Pharma Limited | 59651-943 | 59651-0943-01 |
| lidocaine hydrochloride | Lidocaine hydrochloride 10 mg/mL | Injection, SolutionInfiltration, Perineural | Medical Purchasing Solutions, LLC | 71872-7362 | 71872-7362-01 |
Other NDCs under ANDA 040710
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 Hydrochloride | Lidocaine hydrochloride anhydrous 40 mg/mL | SolutionOral | Bryant Ranch Prepack | 63629-2096 |
| Lidocaine Hydrochloride | Lidocaine hydrochloride anhydrous 40 mg/mL | SolutionOral | Bryant Ranch Prepack | 72162-1098 |