Prescription drug · ANDA
Lidocaine 5% NDC 82347-0505
Lidocaine 50 mg/g · Patch · Topical · YARAL Pharma Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 82347-0505-5 | 8234705050582347050505 | 30 POUCH in 1 PACKAGE (82347-0505-5) / 14 g in 1 POUCH (82347-0505-4)Marketed from Jun 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 5%
- Generic name (nonproprietary)
- lidocaine 5%
- Active ingredients
- Lidocaine — 50 mg/g
- Dosage form
- Patch
- Route
- Topical
- Labeler
- YARAL Pharma Inc.NDC labeler code 82347
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 209190
- Marketing start
- Listing expires
- Other FDA classes
- Amides (Chemical structure)Local Anesthesia (Physiologic effect)
- Identifiers
- Product ID 82347-0505_4dca819d-01d3-65d2-e063-6394a90ac4a6SPL ID 4dca819d-01d3-65d2-e063-6394a90ac4a6SPL set ID fc495fc8-15d6-27c7-e053-6394a90ab30dRxCUI 1745091UNII 98PI200987UPC 0382347050550
- 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
N482347050505followed by a unit qualifier and the quantityPackage 82347-0505-05. 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 patch 5% is indicated for relief of pain associated with post-herpetic neuralgia. It should be applied only to intact skin.
Excerpt only. Read the full label for complete information.
About NDC 82347-0505
- What is NDC 82347-0505?
- 82347-0505 is the product NDC for Lidocaine 5%, Lidocaine 50 mg/g patch, listed with the FDA by YARAL Pharma Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Lidocaine 5%.
- What is the active ingredient?
- Lidocaine.
- Who is the labeler?
- YARAL Pharma Inc., NDC labeler code 82347. 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 5%?
- 7 other product NDCs are listed under this name. See all Lidocaine 5% NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Lidocaine 5% 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 5%lidocaine | Lidocaine 5 g/100g | CreamTopical | Medhome Pharma Inc | 84007-335 | 84007-0335-01 |
| Lidocaine 5% | Lidocaine 50 mg/g | PatchTopical | REMEDYREPACK INC. | 70518-4487 | 70518-4487-00 |
| Lidocaine 5% | Lidocaine 50 mg/g | PatchTopical | St. Mary's Medical Park Pharmacy | 60760-657 | 60760-0657-05 |
| Lidocaine 5% | Lidocaine 50 mg/g | PatchTopical | A-S Medication Solutions | 50090-7857 | 50090-7857-02 |
| Lidocaine 5% | Lidocaine 700 mg/1 | PatchTopical | NuCare Pharmaceuticals,Inc. | 68071-3620 | 68071-3620-03 |
| Lidocaine 5% | Lidocaine 50 mg/g | PatchTopical | Asclemed USA, Inc. | 76420-899 | 76420-0899-30 |
| Lidocaine 5%lidocaine | Lidocaine 5 g/100g | CreamRectal, Topical | Apnar Pharma LP | 24689-124 | 24689-0124-01 |
Other NDCs under ANDA 209190
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 5% | Lidocaine 50 mg/g | PatchTopical | Asclemed USA, Inc. | 76420-899 |
| Lidocaine 5% | Lidocaine 50 mg/g | PatchTopical | St. Mary's Medical Park Pharmacy | 60760-657 |
| Lidocaine 5% | Lidocaine 700 mg/1 | PatchTopical | NuCare Pharmaceuticals,Inc. | 68071-3620 |
| Lidocaine 5% | Lidocaine 50 mg/g | PatchTopical | REMEDYREPACK INC. | 70518-4487 |
| Lidocan Vlidocaine 5% | Lidocaine 50 mg/g | PatchTopical | PURETEK CORPORATION | 59088-909 |
| Lidocan VIIlidocaine 5% | Lidocaine 50 mg/g | PatchTopical | PURETEK CORPORATION | 59088-900 |
| Lidocanlidocaine 5% | Lidocaine 700 mg/1 | PatchTopical | PURETEK CORPORATION | 59088-905 |
| Lidocan IIIlidocaine 5% | Lidocaine 50 mg/g | PatchTopical | PURETEK CORPORATION | 59088-907 |
| Lidocan IVlidocaine 5% | Lidocaine 50 mg/g | PatchTopical | PURETEK CORPORATION | 59088-910 |
| Lidocan VIlidocaine 5% | Lidocaine 50 mg/g | PatchTopical | PURETEK CORPORATION | 59088-911 |
| Lidocaine 5% Patchlidocaine 5% | Lidocaine 700 mg/1 | PatchTopical | Medcore LLC | 82461-611 |
| Lidox 5 Patchlidocaine 5% patch | Lidocaine 50 mg/g | PatchTopical | Injecta Medcial LLC | 87234-0505 |
| Lidocaine 5% | Lidocaine 50 mg/g | PatchTopical | A-S Medication Solutions | 50090-7857 |
| Tridacaine XLlidocaine | Lidocaine 50 mg/g | PatchTopical | Trifluent Pharma LLC | 73352-845 |
| Tridacaine IIIlidocaine | Lidocaine 50 mg/g | PatchTopical | Trifluent Pharma LLC | 73352-835 |