What is NDC 68071-3486?

68071-3486 is the product NDC for Lidocaine hydrochloride, Lidocaine hydrochloride 20 mg/mL solution, listed with the FDA by NuCare Pharmaceuticals,Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.

NuCare Pharmaceuticals,Inc., NDC labeler code 68071. 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.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Lidocaine hydrochloride NDC 68071-3486

NDC codes

FDA NDC Directory

Product NDC (as listed)68071-3486Labeler and product segments. Claims need a package NDC.

Product NDC at billing width68071-3486Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package	Copy
68071-3486-0	6807134860068071348600	100 mL in 1 BOTTLE (68071-3486-0)Marketed from Aug 21, 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: NuCare Pharmaceuticals,Inc.NDC labeler code 68071
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 216780
Marketing start: Mar 28, 2023
Listing expires: Dec 31, 2026
Other FDA classes: Amides (Chemical structure)Local Anesthesia (Physiologic effect)
Identifiers: Product ID 68071-3486_30b5b6e4-f174-1ec5-e063-6394a90a82afSPL ID 30b5b6e4-f174-1ec5-e063-6394a90a82afSPL set ID 037764d3-da0e-5ebb-e063-6294a90ab6e0RxCUI 1010739UNII V13007Z41AUPC 0368071348606
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

N468071348600 followed by a unit qualifier and the quantity

Package 68071-3486-00. 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 Mar 19, 2025. 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.

Full label on DailyMed (opens in a new tab)

About NDC 68071-3486

What is NDC 68071-3486?: 68071-3486 is the product NDC for Lidocaine hydrochloride, Lidocaine hydrochloride 20 mg/mL solution, listed with the FDA by NuCare Pharmaceuticals,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.
Who is the labeler?: NuCare Pharmaceuticals,Inc., NDC labeler code 68071. 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.

Other finished products listed under the same name: strengths, forms and labelers.

Other Lidocaine hydrochloride NDCs
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

All 192 Lidocaine hydrochloride NDCs

Other NDCs under ANDA 216780

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 216780
Product	Strength	Form · route	Labeler	Product NDC
Lidocaine hydrochloride	Lidocaine hydrochloride 20 mg/mL	SolutionOral, Topical	ATLANTIC BIOLOGICALS CORP.	17856-0138
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	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