Prescription drug · ANDA
Lidocaine Hydrochloride NDC 0409-4713
Lidocaine hydrochloride 10 mg/mL · Injection, Solution · Epidural, Infiltration, Intracaudal, Perineural · Hospira, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0409-4713-02 | 00409471302 | 5 CELLO PACK in 1 PACKAGE (0409-4713-02) / 5 AMPULE in 1 CELLO PACK (0409-4713-26) / 5 mL in 1 AMPULE (0409-4713-12)Marketed from Nov 16, 2005 | |
| 0409-4713-32 | 00409471332 | 5 CARTON in 1 PACKAGE (0409-4713-32) / 10 AMPULE in 1 CARTON (0409-4713-25) / 2 mL in 1 AMPULE (0409-4713-42)Marketed from Sep 2, 2005 | |
| 0409-4713-62 | 00409471362 | 800 AMPULE in 1 CASE (0409-4713-62) / 2 mL in 1 AMPULE (0409-4713-72)Marketed from Oct 11, 2005 | |
| 0409-4713-65 | 00409471365 | 800 AMPULE in 1 CASE (0409-4713-65) / 5 mL in 1 AMPULE (0409-4713-75)Marketed from Jul 8, 2005 |
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
- Generic name (nonproprietary)
- lidocaine hydrochloride
- Active ingredients
- Lidocaine hydrochloride — 10 mg/mL
- Dosage form
- Injection, Solution
- Route
- Epidural, Infiltration, Intracaudal, Perineural
- Labeler
- Hospira, Inc.NDC labeler code 0409
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 080408
- Marketing start
- Listing expires
- Other FDA classes
- Amides (Chemical structure)Local Anesthesia (Physiologic effect)
- Identifiers
- Product ID 0409-4713_05d1a200-9d75-4e48-b14a-5069d4ab816fSPL ID 05d1a200-9d75-4e48-b14a-5069d4ab816fSPL set ID 3b2dd84e-cee8-4e58-d494-395a65a353a0RxCUI 1010033, 1010671, 1010900, 1737343, 1737562, 1737566, 1737568, 1737636, 1737757, 1737763UNII 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
N400409471302followed by a unit qualifier and the quantityPackage 00409-4713-02. 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 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 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 Injection contains lidocaine, an amide local anesthetic. Lidocaine Hydrochloride Injection is indicated in adult and pediatric patients for the production of local or regional anesthesia or …
Excerpt only. Read the full label for complete information.
About NDC 0409-4713
- What is NDC 0409-4713?
- 0409-4713 is the product NDC for Lidocaine Hydrochloride, Lidocaine hydrochloride 10 mg/mL injection, solution, listed with the FDA by Hospira, Inc.. It has 4 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?
- Hospira, Inc., NDC labeler code 0409. 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?
- 179 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 | 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 |
| Lidocaine Hydrochloride | Lidocaine hydrochloride 20 mg/mL | SolutionOral, Topical | Aurobindo Pharma Limited | 59651-943 | 59651-0943-01 |
| lidocaine hydrochloride | Lidocaine hydrochloride 10 mg/mL | Injection, SolutionInfiltration, Perineural | Medical Purchasing Solutions, LLC | 71872-7362 | 71872-7362-01 |
Other NDCs under ANDA 080408
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 | Lidocaine hydrochloride 10 mg/mL | Injection, SolutionEpidural, Infiltration, Intracaudal, Perineural | HF Acquisition Co LLC, DBA HealthFirst | 51662-1593 |
| Lidocaine Hydrochloridelidocaine hydrochloride anhydrous | Lidocaine hydrochloride 10 mg/mL | Injection, SolutionInfiltration | Henry Schein, Inc. | 0404-9887 |
| Lidocaine Hydrochloride | Lidocaine hydrochloride 15 mg/mL | Injection, SolutionEpidural, Infiltration, Intracaudal, Perineural | Hospira, Inc. | 0409-4776 |
| Lidocaine Hydrochloride | Lidocaine hydrochloride 10 mg/mL | Injection, SolutionEpidural, Infiltration, Intracaudal, Perineural | Asclemed USA, Inc. | 76420-084 |