Voltaren Gel
NDC Package 0067-8152-08
Package Information
Voltaren (diclofenac sodium) gel is see also Warning section. This formulation utilizes a gel delivery system. Marketed by Haleon Us Holdings Llc, this product is identified by NDC 0067-8152 and is authorized under FDA application NDA022122.
Identification & Billing
- RxCUI: 855633 - diclofenac sodium 1 % Topical Gel
- RxCUI: 855633 - diclofenac sodium 0.01 MG/MG Topical Gel
- RxCUI: 855635 - Voltaren 1 % Topical Gel
- RxCUI: 855635 - diclofenac sodium 0.01 MG/MG Topical Gel [Voltaren]
- RxCUI: 855635 - Voltaren 0.01 MG/MG Topical Gel
Clinical Specifications
Regulatory & Marketing
Hierarchy Structure
- 0067 - Haleon Us Holdings Llc
- 0067-8152 - Voltaren
- 0067-8152-08 - 2 TUBE in 1 CARTON / 100 g in 1 TUBE
- 0067-8152 - Voltaren
The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.
* Please review the full disclaimer at the bottom of this page.
Other Available Packages
The following commercial packages are registered under the same Product NDC (0067-8152). Click a package code to view its specific billing and regulatory data.
* Please review the full disclaimer at the bottom of this page.
Frequently Asked Questions
What is the distribution configuration for this product package?
The code 0067-8152-08 identifies a specific commercial package of 2 tube in 1 carton / 100 g in 1 tube of Voltaren Arthritis Pain, a human over the counter drug labeled by Haleon Us Holdings Llc. This product is billed per "GM" gram and contains an estimated amount of 100 billable units per package. This gel is formulated for topical use and contains diclofenac sodium as the active substance.
Is this product currently listed with the FDA?
Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Haleon Us Holdings Llc on May 13, 2020. The current certification is valid through December 31, 2026.
What are the primary indications for this medication?
See also Warning section. This medication is used to relieve joint pain from arthritis. Diclofenac belongs to a class of drugs known as nonsteroidal anti-inflammatory drugs (NSAIDs). If you are treating a chronic condition such as arthritis, ask your doctor about non-drug treatments and/or using other medications to treat your pain.
How is this Haleon Us Holdings Llc product billed for insurance claims?
For medical billing and reimbursement, this package follows the 11-digit CMS format: 00067815208. Quantities are measured in per "gm or gram", products billed per gram are products measured by weight.. There are 100 total billable units per package. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.
11-Digit Code Conversion
Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:
Note: The zero is added to the Labeler segment to maintain the 5-4-2 structure.
