Prescription drug · ANDA
Lidocaine Hydrochloride NDC 62135-712
Lidocaine hydrochloride anhydrous 20 mg/mL · Solution · Oropharyngeal · Chartwell RX, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 62135-712-42 | 62135071242 | 100 mL in 1 BOTTLE (62135-712-42)Marketed from Jun 16, 2023 |
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 Hydrochloride
- Generic name (nonproprietary)
- lidocaine hydrochloride
- Active ingredients
- Lidocaine hydrochloride anhydrous — 20 mg/mL
- Dosage form
- Solution
- Route
- Oropharyngeal
- Labeler
- Chartwell RX, LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 040708
- Marketing start
- Listing expires
- Other FDA classes
- Amides (Chemical structure)Local Anesthesia (Physiologic effect)
- Identifiers
- Product ID 62135-712_4936d399-9101-8558-e063-6294a90a639cSPL ID 4936d399-9101-8558-e063-6294a90a639cSPL set ID c05f49a2-7512-48e7-9730-f8ee05519b9dRxCUI 1010739UNII EC2CNF7XFPUPC 0362135712426
- 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
N462135071242followed by a unit qualifier and the quantityPackage 62135-0712-42. 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 . This label includes a boxed warning.
Indications (excerpt from the label)
INDICATIONS AND USAGE Lidocaine hydrochloride oral topical solution USP, 2% (viscous) is indicated for the production of topical anesthesia of irritated or inflamed mucous membranes of the mouth and pharynx. It is also useful for reducing gagging during the taking of X-ray pictures and dental impressions.
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 040708
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 20 mg/mL | SolutionOropharyngeal | Chartwell Governmental & Specialty RX, LLC. | 68999-871 |
| Lidocaine Hydrochloride | Lidocaine hydrochloride anhydrous 20 mg/mL | SolutionOropharyngeal | Chartwell RX, LLC | 62135-871 |