Prescription drug · ANDA
Lidocaine hydrochloride NDC 17856-0138
Lidocaine hydrochloride 20 mg/mL · Solution · Oral, Topical · ATLANTIC BIOLOGICALS CORP.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 17856-0138-1 | 1785601380117856013801 | 50 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE (17856-0138-1) / 15 mL in 1 CUP, UNIT-DOSE (17856-0138-3)Marketed from Sep 19, 2023 | |
| 17856-0138-2 | 1785601380217856013802 | 50 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE (17856-0138-2) / 20 mL in 1 CUP, UNIT-DOSE (17856-0138-4)Marketed from Sep 19, 2023 | |
| 17856-0138-5 | 1785601380517856013805 | 72 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE (17856-0138-5) / 5 mL in 1 CUP, UNIT-DOSE (17856-0138-6)Marketed from Sep 19, 2023 |
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 — 20 mg/mL
- Dosage form
- Solution
- Route
- Oral, Topical
- Labeler
- ATLANTIC BIOLOGICALS CORP.NDC labeler code 17856
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 216780
- Marketing start
- Listing expires
- Other FDA classes
- Amides (Chemical structure)Local Anesthesia (Physiologic effect)
- Identifiers
- Product ID 17856-0138_34f4d3da-f769-0bdd-e063-6394a90a3fa1SPL ID 34f4d3da-f769-0bdd-e063-6394a90a3fa1SPL set ID 75d17334-6876-42d0-8a02-82669d139e4fRxCUI 1010739UNII 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. Oral, Topical products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N417856013801followed by a unit qualifier and the quantityPackage 17856-0138-01. 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 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.
About NDC 17856-0138
- What is NDC 17856-0138?
- 17856-0138 is the product NDC for Lidocaine hydrochloride, Lidocaine hydrochloride 20 mg/mL solution, listed with the FDA by ATLANTIC BIOLOGICALS CORP.. It has 3 package NDCs, 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?
- ATLANTIC BIOLOGICALS CORP., NDC labeler code 17856. 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 216780
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 | Atlantic Biologicals Corp. | 17856-8138 |
| Lidocaine hydrochloride | Lidocaine hydrochloride 20 mg/mL | SolutionOral, Topical | A-S Medication Solutions | 50090-7040 |
| Lidocaine hydrochloride | Lidocaine hydrochloride 20 mg/mL | SolutionOral, Topical | American Health Packaging | 60687-870 |
| Lidocaine hydrochloride | Lidocaine hydrochloride 20 mg/mL | SolutionOral, Topical | NuCare Pharmaceuticals,Inc. | 68071-3486 |
| Lidocaine hydrochloride | Lidocaine hydrochloride 20 mg/mL | SolutionOral, Topical | Preferred Pharmaceuticals Inc. | 68788-8507 |
| Lidocaine hydrochloride | Lidocaine hydrochloride 20 mg/mL | SolutionOral, Topical | REMEDYREPACK INC. | 70518-4030 |
| Lidocaine hydrochloride | Lidocaine hydrochloride 20 mg/mL | SolutionOral, Topical | Advagen Pharma Ltd | 72888-125 |