Prescription drug · ANDA
Lidocaine NDC 83008-044
Lidocaine 50 mg/g · Ointment · Topical · Quality Care Products, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 83008-044-50 | 8300800445083008004450 | 1 JAR in 1 CARTON (83008-044-50) / 50 g in 1 JARMarketed from Jun 26, 2024 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 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
- Generic name (nonproprietary)
- lidocaine
- Active ingredients
- Lidocaine — 50 mg/g
- Dosage form
- Ointment
- Route
- Topical
- Labeler
- Quality Care Products, LLCNDC labeler code 83008
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 086724
- Marketing start
- Marketing end
- Other FDA classes
- Amides (Chemical structure)Local Anesthesia (Physiologic effect)
- Identifiers
- Product ID 83008-044_05f32709-cec2-43a1-b32a-84709e07f15aSPL ID 05f32709-cec2-43a1-b32a-84709e07f15aSPL set ID 7bb5c092-91da-4789-b348-58548703d716RxCUI 1543069UNII 98PI200987
- 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
N483008004450followed by a unit qualifier and the quantityPackage 83008-0044-50. 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 Ointment USP, 5% is indicated for production of anesthesia of accessible mucous membranes of the oropharynx. It is also useful as an anesthetic lubricant for intubation and for the temporary relief of pain associated with minor burns, including sunburn, abrasions of the skin, and insect bites.
Excerpt only. Read the full label for complete information.
About NDC 83008-044
- What is NDC 83008-044?
- 83008-044 is the product NDC for Lidocaine, Lidocaine 50 mg/g ointment, listed with the FDA by Quality Care Products, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Lidocaine.
- What is the active ingredient?
- Lidocaine.
- Who is the labeler?
- Quality Care Products, LLC, NDC labeler code 83008. 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?
- 160 other product NDCs are listed under this name. See all Lidocaine NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Lidocaine 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 | Lidocaine 50 mg/g | OintmentTopical | Direct_Rx | 72189-692 | 72189-0692-50 |
| Lidocaine | Lidocaine 50 mg/g | OintmentTopical | Preferred Pharmaceuticals Inc. | 68788-4195 | 68788-4195-05 |
| Lidocaine | Lidocaine 50 mg/g | PatchTopical | Ascend Laboratories, LLC | 67877-767 | 67877-0767-30 |
| Lidocaine | Lidocaine 80 mg/mL | SprayTopical | YYBA CORP | 73581-900 | 73581-0900-01 |
| Lidocaine | Lidocaine 50 mg/g | OintmentTopical | Advanced Rx of Tennessee, LLC | 80425-0594 | 80425-0594-01 |
| Lidocainelidocaine hydrochloride | Lidocaine hydrochloride 20 mg/mL | JellyTopical | Sentiss Pharmaceuticals LLC | 70244-039 | 70244-0039-0170244-0039-02 |
| Lidocaine | Lidocaine 100 kg/100kg | GranuleTopical | Shaanxi Shuvita Biotech Co., Ltd | 87879-002 | 87879-0002-02 |
| Lidocainelidicaine | Lidocaine 50 mg/g | OintmentTopical | Encube Ethicals, Inc. | 21922-107 | 21922-0107-1321922-0107-61 |
| Lidocaine | Lidocaine hydrochloride 50 mg/mL | GelTopical | YYBA Corp | 73581-115 | 73581-0115-03 |
| Lidocaine | Lidocaine 5 g/100mL | CreamTopical | YYBA Corp | 73581-022 | 73581-0022-06 |
Other NDCs under ANDA 086724
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 | Lidocaine 50 mg/g | OintmentTopical | ATLANTIC BIOLOGICALS CORP. | 17856-3008 |
| Lidocaine | Lidocaine 50 mg/g | OintmentTopical | DIRECT RX | 72189-165 |
| Lidocaine | Lidocaine 50 mg/g | OintmentTopical | Advanced Rx of Tennessee, LLC | 80425-0538 |
| Lidocaine | Lidocaine 50 mg/g | OintmentTopical | PHOENIX RX LLC | 85509-3008 |
| Lidocaine | Lidocaine 50 mg/g | OintmentTopical | Golden State Medical Supply, Inc. | 51407-383 |
| Lidocaine | Lidocaine 50 mg/g | OintmentTopical | DIRECT RX | 72189-211 |
| Lidocaine | Lidocaine 50 mg/g | OintmentTopical | NuCare Pharmaceuticals, Inc. | 68071-3792 |
| Lidocaine | Lidocaine 50 mg/g | OintmentTopical | Advanced Rx of Tennessee, LLC | 80425-0594 |
| Lidocaine | Lidocaine 50 mg/g | OintmentTopical | Proficient Rx LP | 71205-288 |
| Lidocaine | Lidocaine 50 mg/g | OintmentTopical | A-S Medication Solutions | 50090-8011 |
| Lidocaine | Lidocaine 50 mg/g | OintmentTopical | Preferred Pharmaceuticals Inc. | 68788-4050 |
| Lidocaine | Lidocaine 50 mg/g | OintmentTopical | Sun Pharmaceutical Industries, Inc. | 51672-3020 |
| Lidocaine | Lidocaine 50 mg/g | OintmentTopical | Sun Pharmaceutical Industries, Inc. | 51672-3008 |