Prescription drug · ANDA
Lidocaine Viscous (Lidocaine hydrochloride) NDC 0054-3500
Lidocaine hydrochloride 20 mg/mL · Solution · Oral, Topical · Hikma Pharmaceuticals USA Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0054-3500-49 | 00054350049 | 1 BOTTLE in 1 CARTON (0054-3500-49) / 100 mL in 1 BOTTLEMarketed from Apr 26, 1985 |
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 Viscous
- Generic name (nonproprietary)
- lidocaine hydrochloride
- Active ingredients
- Lidocaine hydrochloride — 20 mg/mL
- Dosage form
- Solution
- Route
- Oral, Topical
- Labeler
- Hikma Pharmaceuticals USA Inc.NDC labeler code 0054
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 088802
- Marketing start
- Listing expires
- Other FDA classes
- Amides (Chemical structure)Local Anesthesia (Physiologic effect)
- Identifiers
- Product ID 0054-3500_182f3e6b-1622-4eef-80e5-d08ffbbbd30eSPL ID 182f3e6b-1622-4eef-80e5-d08ffbbbd30eSPL set ID 79b42076-359d-4258-b1d8-f40e67ac5424RxCUI 1010739UNII V13007Z41AUPC 0300543500495
- 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, Topical products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N400054350049followed by a unit qualifier and the quantityPackage 00054-3500-49. 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 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.
About NDC 0054-3500
- What is NDC 0054-3500?
- 0054-3500 is the product NDC for Lidocaine Viscous (lidocaine hydrochloride), Lidocaine hydrochloride 20 mg/mL solution, listed with the FDA by Hikma Pharmaceuticals USA Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Lidocaine Viscous (Lidocaine Hydrochloride).
- What is the active ingredient?
- Lidocaine hydrochloride.
- Who is the labeler?
- Hikma Pharmaceuticals USA Inc., NDC labeler code 0054. 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 Viscous?
- 2 other product NDCs are listed under this name. See all Lidocaine Viscous NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Lidocaine Viscous 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 Viscouslidocaine hydrochloride | Lidocaine hydrochloride 20 mg/mL | SolutionOral, Topical | REMEDYREPACK INC. | 70518-4278 | 70518-4278-00 |
| Lidocaine Viscouslidocaine hydrochloride | Lidocaine hydrochloride 20 mg/mL | SolutionOral, Topical | A-S Medication Solutions | 50090-6186 | 50090-6186-00 |
Other NDCs under ANDA 088802
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 20 mg/mL | SolutionOral, Topical | NuCare Pharmaceuticals,Inc. | 68071-3449 |
| Lidocaine Viscouslidocaine hydrochloride | Lidocaine hydrochloride 20 mg/mL | SolutionOral, Topical | A-S Medication Solutions | 50090-6186 |
| Lidocaine Viscouslidocaine hydrochloride | Lidocaine hydrochloride 20 mg/mL | SolutionOral, Topical | REMEDYREPACK INC. | 70518-4278 |