Prescription drug · ANDA
Lidocaine Hydrochloride and Epinephrine NDC 0404-9788
Lidocaine hydrochloride 20 mg/mL; Epinephrine 10 ug/mL · Injection, Solution · Infiltration, Perineural · Henry Schein, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0404-9788-20 | 00404978820 | 1 VIAL, MULTI-DOSE in 1 BAG (0404-9788-20) / 20 mL in 1 VIAL, MULTI-DOSEMarketed from Feb 17, 2025 |
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 — 20 mg/mLEpinephrine — 10 ug/mL
- Dosage form
- Injection, Solution
- Route
- Infiltration, Perineural
- Labeler
- Henry Schein, Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 089646
- 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 0404-9788_96589b9d-b9c8-49f5-a5a4-5abdf8d00dd0SPL ID 96589b9d-b9c8-49f5-a5a4-5abdf8d00dd0SPL set ID 5692e28d-559c-4b6a-8421-fa85d7155818RxCUI 1010759UNII 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
N400404978820followed by a unit qualifier and the quantityPackage 00404-9788-20. 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)
INDICATIONS AND USAGE Lidocaine Hydrochloride and Epinephrine Injection, USP is indicated for production of local or regional anesthesia by infiltration techniques such as percutaneous injection, 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.
Other NDCs under ANDA 089646
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 HCl AND EPINEPHRINE | Lidocaine hydrochloride 20 mg/mL; Epinephrine 10 ug/mL | Injection, SolutionInfiltration, Perineural | HF Acquisition Co LLC, DBA HealthFirst | 51662-1503 |
| LIDOCAINE HCl AND EPINEPHRINE | Epinephrine 10 ug/mL; Lidocaine hydrochloride 20 mg/mL | Injection, SolutionInfiltration, Perineural | HF Acquisition Co LLC, DBA HealthFirst | 51662-1504 |
| Lidocaine Hydrochloride and Epinephrine | Lidocaine hydrochloride 20 mg/mL; Epinephrine 10 ug/mL | Injection, SolutionInfiltration, Perineural | Hospira, Inc. | 0409-3182 |
| Lidocaine Hydrochloride and Epinephrine | Lidocaine hydrochloride 20 mg/mL; Epinephrine 10 ug/mL | Injection, SolutionInfiltration, Perineural | ProPharma Distribution | 84549-182 |
| Lidocaine Hydrochloride and Epinephrine | Lidocaine hydrochloride 20 mg/mL; Epinephrine 10 ug/mL | Injection, SolutionInfiltration, Perineural | Hospira, Inc. | 0409-0147 |
| Lidocaine Hydrochloride and Epinephrine | Lidocaine hydrochloride 20 mg/mL; Epinephrine 10 ug/mL | Injection, SolutionInfiltration, Perineural | Henry Schein, Inc. | 0404-9896 |