Prescription drug · ANDA
Lidocaine Hydrochloride NDC 76329-3013
Lidocaine hydrochloride 20 mg/mL · Jelly · Topical · International Medication Systems, Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 76329-3013-5 | 7632930130576329301305 | 25 VIAL, SINGLE-USE in 1 BOX (76329-3013-5) / 10 mL in 1 VIAL, SINGLE-USEMarketed from Aug 7, 1979 |
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
- Jelly
- Route
- Topical
- Labeler
- International Medication Systems, LimitedNDC labeler code 76329
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 086283
- Marketing start
- Listing expires
- Other FDA classes
- Amides (Chemical structure)Local Anesthesia (Physiologic effect)
- Identifiers
- Product ID 76329-3013_483019ba-e338-42f2-82da-2401e40e417cSPL ID 483019ba-e338-42f2-82da-2401e40e417cSPL set ID 0cbc37d3-c2d6-4747-9834-7c23b38fcc20RxCUI 1011852UNII 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 HCPCS code in Med-Code's directory. Topical products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N476329301305followed by a unit qualifier and the quantityPackage 76329-3013-05. 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 Jelly USP, 2% is indicated for prevention and control of pain in procedures involving the male and female urethra for topical treatment of painful urethritis, and as an anesthetic lubricant for endotracheal intubation (oral and nasal).
Excerpt only. Read the full label for complete information.
About NDC 76329-3013
- What is NDC 76329-3013?
- 76329-3013 is the product NDC for Lidocaine Hydrochloride, Lidocaine hydrochloride 20 mg/mL jelly, listed with the FDA by International Medication Systems, Limited. 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?
- International Medication Systems, Limited, NDC labeler code 76329. 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.
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 | 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 |
Other NDCs under ANDA 086283
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 20 mg/mL | JellyTopical | HF Acquisition Co LLC, DBA HealthFirst | 51662-1389 |
| Lidocaine Hydrochloride | Lidocaine hydrochloride 20 mg/mL | JellyTopical | Henry Schein, Inc. | 0404-9898 |
| Lidocaine Hydrochloride | Lidocaine hydrochloride 20 mg/mL | JellyTopical | Henry Schein, Inc. | 0404-9899 |
| Lidocaine Hydrochloride | Lidocaine hydrochloride 20 mg/mL | JellyTopical | Henry Schein, Inc. | 0404-9900 |
| Lidocaine Hydrochloride | Lidocaine hydrochloride 20 mg/mL | JellyTopical | HF Acquisition Co LLC, DBA HealthFirst | 51662-1551 |
| Lidocaine Hydrochloride | Lidocaine hydrochloride 20 mg/mL | JellyTopical | HF Acquisition Co LLC, DBA HealthFirst | 51662-1552 |
| Lidocaine Hydrochloride | Lidocaine hydrochloride 20 mg/mL | JellyTopical | International Medication Systems, Limited | 76329-3011 |
| Lidocaine Hydrochloride | Lidocaine hydrochloride 20 mg/mL | JellyTopical | International Medication Systems, Limited | 76329-3012 |
| Lidocaine Hydrochloride | Lidocaine hydrochloride 20 mg/mL | JellyTopical | International Medication Systems, Limited | 76329-3015 |