Prescription drug · ANDA

Lidocaine hydrochloride NDC 80425-0268

Lidocaine hydrochloride 10 mg/mL · Injection, Solution · Epidural, Infiltration, Intracaudal, Perineural · Advanced Rx Pharmacy of Tennessee, LLC

NDC codes

FDA NDC Directory
Product NDC (as listed)80425-0268Labeler and product segments. Claims need a package NDC.
Product NDC at billing width80425-0268Add 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 NDC11-digit (billing)PackageCopy
80425-0268-1804250268011 VIAL, SINGLE-DOSE in 1 CARTON (80425-0268-1) / 30 mL in 1 VIAL, SINGLE-DOSEMarketed from Feb 15, 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 — 10 mg/mL
Dosage form
Injection, Solution
Route
Epidural, Infiltration, Intracaudal, Perineural
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 203082
Marketing start
Listing expires
Other FDA classes
Amides (Chemical structure)Local Anesthesia (Physiologic effect)
Identifiers
Product ID 80425-0268_2a9b9724-0254-e829-e063-6394a90a1c07SPL ID 2a9b9724-0254-e829-e063-6394a90a1c07SPL set ID f4c19cf5-c8b1-5e9f-e053-2995a90aee53RxCUI 1737562UNII 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 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

N480425026801 followed by a unit qualifier and the quantity

Package 80425-0268-01. 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 .

Indications (excerpt from the label)

Lidocaine hydrochloride injection is indicated for production of local or regional anesthesia by infiltration techniques such as percutaneous injection and intravenous regional anesthesia by peripheral nerve block techniques such as brachial plexus and intercostal and by central neural techniques such as lumbar and caudal epidural blocks, when the accepted procedures for these techniques as described in standard textbooks are observed.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 203082

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

FDA NDC Directory listings under ANDA 203082
ProductStrengthForm · routeLabelerProduct NDC
Lidocaine HydrochlorideLidocaine hydrochloride 20 mg/mLInjection, SolutionEpidural, Infiltration, Intracaudal, PerineuralMedical Purchasing Solutions, LLC71872-7144
Lidocaine HydrochlorideLidocaine hydrochloride 10 mg/mLInjection, SolutionEpidural, Infiltration, Intracaudal, PerineuralEugia US LLC55150-161
Lidocaine HydrochlorideLidocaine hydrochloride 10 mg/mLInjection, SolutionEpidural, Infiltration, Intracaudal, PerineuralEugia US LLC55150-163
Lidocaine HydrochlorideLidocaine hydrochloride 10 mg/mLInjection, SolutionEpidural, Infiltration, Intracaudal, PerineuralEugia US LLC55150-161
Lidocaine HydrochlorideLidocaine hydrochloride 10 mg/mLInjection, SolutionEpidural, Infiltration, Intracaudal, PerineuralEugia US LLC55150-162
Lidocaine HydrochlorideLidocaine hydrochloride 10 mg/mLInjection, SolutionEpidural, Infiltration, Intracaudal, PerineuralEugia US LLC55150-162
Lidocaine HydrochlorideLidocaine hydrochloride 20 mg/mLInjection, SolutionEpidural, Infiltration, Intracaudal, PerineuralEugia US LLC55150-165
Lidocaine HciLidocaine hydrochloride 20 mg/mLInjection, SolutionEpidural, Infiltration, Intracaudal, PerineuralHF Acquisition Co LLC, DBA HealthFirst51662-1543
Lidocaine HydrochlorideLidocaine hydrochloride 10 mg/mLInjection, SolutionEpidural, Infiltration, Intracaudal, PerineuralEugia US LLC55150-163
Lidocaine HydrochlorideLidocaine hydrochloride 20 mg/mLInjection, SolutionEpidural, Infiltration, Intracaudal, PerineuralEugia US LLC55150-164
Lidocaine HydrochlorideLidocaine hydrochloride 20 mg/mLInjection, SolutionEpidural, Infiltration, Intracaudal, PerineuralEugia US LLC55150-164
Lidocaine HydrochlorideLidocaine hydrochloride 20 mg/mLInjection, SolutionEpidural, Infiltration, Intracaudal, PerineuralEugia US LLC55150-165
Lidocaine HydrochlorideLidocaine hydrochloride 10 mg/mLInjection, SolutionEpidural, Infiltration, Intracaudal, PerineuralHF Acquisition Co LLC, DBA HealthFirst51662-1651
Lidocaine HydrochlorideLidocaine hydrochloride 10 mg/mLInjection, SolutionEpidural, Infiltration, Intracaudal, PerineuralAsclemed USA, Inc.76420-080
Lidocaine HydrochlorideLidocaine hydrochloride 20 mg/mLInjection, SolutionEpidural, Infiltration, Intracaudal, PerineuralAsclemed USA, Inc.76420-540
Lidocaine HydrochlorideLidocaine hydrochloride 20 mg/mLInjection, SolutionEpidural, Infiltration, Intracaudal, PerineuralHenry Schein, Inc.0404-9897
Lidocaine HydrochlorideLidocaine hydrochloride 10 mg/mLInjection, SolutionEpidural, Infiltration, Intracaudal, PerineuralSportpharm LLC85766-211

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