Prescription drug · ANDA
Lidocaine Hydrochloride and Epinephrine NDC 0404-9891
Lidocaine hydrochloride 10 mg/mL; Epinephrine 10 ug/mL · Injection, Solution · Infiltration · Henry Schein, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0404-9891-20 | 0040498912000404989120 | 1 VIAL, MULTI-DOSE in 1 BAG (0404-9891-20) / 30 mL in 1 VIAL, MULTI-DOSEMarketed from Jan 12, 2022 | |
| 0404-9891-50 | 0040498915000404989150 | 1 VIAL, MULTI-DOSE in 1 BAG (0404-9891-50) / 50 mL in 1 VIAL, MULTI-DOSEMarketed from Jan 12, 2022 |
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 Hydrochloride and Epinephrine
- Generic name (nonproprietary)
- lidocaine hydrochloride and epinephrine
- Active ingredients
- Lidocaine hydrochloride — 10 mg/mLEpinephrine — 10 ug/mL
- Dosage form
- Injection, Solution
- Route
- Infiltration
- Labeler
- Henry Schein, Inc.NDC labeler code 0404
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 089644
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic alpha-Agonists (Mechanism)Adrenergic beta-Agonists (Mechanism)Amides (Chemical structure)Catecholamines (Chemical structure)Local Anesthesia (Physiologic effect)
- Identifiers
- Product ID 0404-9891_e7e3772b-2b6d-4103-8ccf-f62a909ec353SPL ID e7e3772b-2b6d-4103-8ccf-f62a909ec353SPL set ID c3490a23-14c4-43f7-b066-96a4c4298fdeRxCUI 1010751UNII V13007Z41A, YKH834O4BH
- Pharmacologic class
- Amide Local Anesthetic; Antiarrhythmic; Catecholamine; alpha-Adrenergic Agonist; beta-Adrenergic Agonist
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
N400404989120followed by a unit qualifier and the quantityPackage 00404-9891-20. 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 and Epinephrine Injection is indicated in adult and pediatric patients for the production of local or regional anesthesia or analgesia for surgery, dental, and oral surgery procedures, diagnostic and therapeutic procedures, and for obstetrical procedures. Specific concentrations and presentations of Lidocaine Hydrochloride and Epinephrine Injection are recommended for each type of block indicated to produce local or regional anesthesia or analgesia [see Dosage and Administration (2.2)]. Lidocaine Hydrochloride and Epinephrine Injection is a combination of lidocaine, an amide local anesthetic, and epinephrine, an alpha and beta adrenergic agonist. Lidocaine Hydrochlori…
Excerpt only. Read the full label for complete information.
About NDC 0404-9891
- What is NDC 0404-9891?
- 0404-9891 is the product NDC for Lidocaine Hydrochloride and Epinephrine, Lidocaine hydrochloride 10 mg/mL; Epinephrine 10 ug/mL injection, solution, listed with the FDA by Henry Schein, Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Lidocaine Hydrochloride and Epinephrine.
- What is the active ingredient?
- Lidocaine hydrochloride, Epinephrine.
- Who is the labeler?
- Henry Schein, Inc., NDC labeler code 0404. 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 and Epinephrine?
- 14 other product NDCs are listed under this name. See all Lidocaine Hydrochloride and Epinephrine 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 and Epinephrine 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 and Epinephrine | Lidocaine hydrochloride 20 mg/mL; Epinephrine 10 ug/mL | Injection, SolutionInfiltration, Perineural | Henry Schein, Inc. | 0404-9788 | 00404-9788-20 |
| Lidocaine Hydrochloride and Epinephrine | Lidocaine hydrochloride 10 mg/mL; Epinephrine 10 ug/mL | Injection, SolutionInfiltration, Perineural | Hospira, Inc. | 0409-0007 | 00409-0007-10 |
| Lidocaine Hydrochloride and Epinephrine | Lidocaine hydrochloride 20 mg/mL; Epinephrine 10 ug/mL | Injection, SolutionInfiltration, Perineural | Hospira, Inc. | 0409-0147 | 00409-0147-10 |
| Lidocaine Hydrochloride and Epinephrine | Lidocaine hydrochloride 20 mg/mL; Epinephrine 10 ug/mL | Injection, SolutionInfiltration, Perineural | Henry Schein, Inc. | 0404-9896 | 00404-9896-3000404-9896-50 |
| Lidocaine Hydrochloride and Epinephrine | Lidocaine hydrochloride 5 mg/mL; Epinephrine 5 ug/mL | Injection, SolutionInfiltration, Perineural | Henry Schein, Inc. | 0404-9886 | 00404-9886-50 |
| Lidocaine Hydrochloride and Epinephrine | Lidocaine hydrochloride 10 mg/mL; Epinephrine 10 ug/mL | Injection, SolutionInfiltration, Perineural | Cardinal Health 107, LLC | 55154-0132 | 55154-0132-05 |
| Lidocaine Hydrochloride and Epinephrine | Lidocaine hydrochloride 5 mg/mL; Epinephrine 5 ug/mL | Injection, SolutionInfiltration, Perineural | Hospira, Inc. | 0409-3177 | 00409-3177-01 |
| Lidocaine Hydrochloride and Epinephrine | Lidocaine hydrochloride 10 mg/mL; Epinephrine 10 ug/mL | Injection, SolutionInfiltration, Perineural | Hospira, Inc. | 0409-3178 | 00409-3178-0100409-3178-0200409-3178-03 |
| Lidocaine Hydrochloride and Epinephrine | Lidocaine hydrochloride 10 mg/mL; Epinephrine 10 ug/mL | Injection, SolutionInfiltration, Perineural | Sportpharm LLC | 85766-073 | 85766-0073-2585766-0073-50 |
| Lidocaine Hydrochloride and Epinephrine | Lidocaine hydrochloride 20 mg/mL; Epinephrine 5 ug/mL | Injection, SolutionEpidural, Infiltration, Intracaudal, Perineural | Hospira, Inc. | 0409-3183 | 00409-3183-01 |
Other NDCs under ANDA 089644
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 Hci | Lidocaine hydrochloride 10 mg/mL; Epinephrine 10 ug/mL | Injection, SolutionInfiltration, Perineural | HF Acquisition Co LLC, DBA HealthFirst | 51662-1232 |
| Lidocaine Hci And Epinephrine | Lidocaine hydrochloride 10 mg/mL; Epinephrine 10 ug/mL | Injection, SolutionInfiltration, Perineural | HF Acquisition Co LLC, DBA HealthFirst | 51662-1395 |
| Lidocaine Hydrochloride and Epinephrine | Lidocaine hydrochloride 10 mg/mL; Epinephrine 10 ug/mL | Injection, SolutionInfiltration, Perineural | Hospira, Inc. | 0409-0007 |
| Lidocaine Hydrochloride and Epinephrine | Lidocaine hydrochloride 10 mg/mL; Epinephrine 10 ug/mL | Injection, SolutionInfiltration, Perineural | Hospira, Inc. | 0409-3178 |
| Lidocaine Hydrochloride and Epinephrine | Lidocaine hydrochloride 10 mg/mL; Epinephrine 10 ug/mL | Injection, SolutionInfiltration, Perineural | Cardinal Health 107, LLC | 55154-0132 |
| Lidocaine Hydrochloride and Epinephrine | Lidocaine hydrochloride 10 mg/mL; Epinephrine 10 ug/mL | Injection, SolutionInfiltration, Perineural | Sportpharm LLC | 85766-073 |