Prescription drug · ANDA
Lidocaine Hydrochloride NDC 70954-518
Lidocaine hydrochloride 40 mg/mL · Solution · Topical · Novitium Pharma LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70954-518-10 | 70954051810 | 1 BOTTLE in 1 CARTON (70954-518-10) / 50 mL in 1 BOTTLEMarketed from Mar 23, 2022 |
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 — 40 mg/mL
- Dosage form
- Solution
- Route
- Topical
- Labeler
- Novitium Pharma LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 216250
- Marketing start
- Listing expires
- Other FDA classes
- Amides (Chemical structure)Local Anesthesia (Physiologic effect)
- Identifiers
- Product ID 70954-518_ffb2d794-2c88-48a2-beff-d01b6fcea51fSPL ID ffb2d794-2c88-48a2-beff-d01b6fcea51fSPL set ID ffb2d794-2c88-48a2-beff-d01b6fcea51fRxCUI 1010878UNII V13007Z41AUPC 0370954518105
- 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
N470954051810followed by a unit qualifier and the quantityPackage 70954-0518-10. 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 Lidocaine hydrochloride 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.
Other NDCs under ANDA 216250
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 40 mg/mL | SolutionTopical | Marlex Pharmaceuticals, Inc. | 10135-736 |