Prescription drug · ANDA
Lidocaine NDC 0591-3525
Lidocaine 50 mg/g · Patch · Topical · Actavis Pharma, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0591-3525-30 | 0059135253000591352530 | 30 POUCH in 1 CARTON (0591-3525-30) / 1 g in 1 POUCH (0591-3525-11)Marketed from Sep 15, 2013 |
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
- Generic name (nonproprietary)
- lidocaine
- Active ingredients
- Lidocaine — 50 mg/g
- Dosage form
- Patch
- Route
- Topical
- Labeler
- Actavis Pharma, Inc.NDC labeler code 0591
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 200675
- Marketing start
- Marketing end
- Other FDA classes
- Amides (Chemical structure)Local Anesthesia (Physiologic effect)
- Identifiers
- Product ID 0591-3525_7e68f396-fae0-4c14-91cc-8a94810120d0SPL ID 7e68f396-fae0-4c14-91cc-8a94810120d0SPL set ID 4d04052c-3e0a-469a-9265-99604f13e507RxCUI 1745091UNII 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
N400591352530followed by a unit qualifier and the quantityPackage 00591-3525-30. 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 .
About NDC 0591-3525
- What is NDC 0591-3525?
- 0591-3525 is the product NDC for Lidocaine, Lidocaine 50 mg/g patch, listed with the FDA by Actavis Pharma, Inc.. 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?
- Actavis Pharma, Inc., NDC labeler code 0591. 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?
- 157 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 200675
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 | PatchTopical | Actavis Pharma, Inc. | 0591-2679 |
| Lidocaine | Lidocaine 50 mg/g | PatchCutaneous | Cardinal Health 107, LLC | 55154-2665 |
| Lidocaine | Lidocaine 50 mg/g | PatchTopical | PureTek Corporation | 59088-396 |
| Lidocaine | Lidocaine 50 mg/g | PatchTopical | Bryant Ranch Prepack | 63629-5094 |
| Lidocaine | Lidocaine 50 mg/g | PatchCutaneous | Bryant Ranch Prepack | 63629-7059 |
| Lidocaine | Lidocaine 50 mg/g | PatchTopical | Bryant Ranch Prepack | 63629-8755 |
| Lidocaine | Lidocaine 50 mg/g | PatchTopical | Asclemed USA, Inc. | 76420-037 |
| Tridacaine IIlidocaine | Lidocaine 50 mg/g | PatchTopical | Trifluent Pharma LLC | 73352-830 |