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NDC 42291-0055-12 Diclofenac sodium 20 mg/g Details
Diclofenac sodium 20 mg/g
Diclofenac sodium is a TOPICAL SOLUTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by AvKARE. The primary component is DICLOFENAC SODIUM.
MedlinePlus Drug Summary
Nonprescription (over-the-counter) diclofenac topical gel (Voltaren Arthritis Pain) is used to relieve pain from arthritis in certain joints such as those of the knees, ankles, feet, elbows, wrists, and hands. Prescription diclofenac topical solution (Pennsaid) is used to relieve osteoarthritis pain in the knees. Diclofenac is in a class of medications called nonsteroidal anti-inflammatory drugs (NSAIDs). It works by stopping the body's production of a substance that causes pain. Diclofenac is also available as a 3% gel (Solaraze; generic) that is applied to the skin to treat actinic keratosis (flat, scaly growths on the skin caused by too much sun exposure). This monograph only gives information about nonprescription diclofenac topical gel (Voltaren Arthritis Pain) for arthritis and prescription topical solution (Pennsaid) for osteoarthritis of the knee. If you are using diclofenac gel (Solaraze, generic) for actinic keratosis, read the monograph entitled diclofenac topical (actinic keratosis).
Related Packages: 42291-0055-12Last Updated: 04/07/2024
MedLinePlus Full Drug Details: Diclofenac Topical (arthritis pain)
Product Information
| NDC | 42291-0055 |
|---|---|
| Product ID | 42291-055_0416b0c0-2568-5f9d-e063-6294a90a8aef |
| Associated GPIs | |
| GCN Sequence Number | 071910 |
| GCN Sequence Number Description | diclofenac sodium SOL MD PMP 20MG/G(2%) TOPICAL |
| HIC3 | Q5E |
| HIC3 Description | TOPICAL ANTI-INFLAMMATORY, NSAIDS |
| GCN | 35936 |
| HICL Sequence Number | 003733 |
| HICL Sequence Number Description | DICLOFENAC SODIUM |
| Brand/Generic | Generic |
| Proprietary Name | Diclofenac sodium |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Diclofenac sodium |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | SOLUTION |
| Route | TOPICAL |
| Active Ingredient Strength | 20 |
| Active Ingredient Units | mg/g |
| Substance Name | DICLOFENAC SODIUM |
| Labeler Name | AvKARE |
| Pharmaceutical Class | Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Prostaglandin Production [PE], Nonsteroidal Anti-inflammatory Drug [EPC] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA212506 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 42291-0055-12 (42291005512)
| NDC Package Code | 42291-055-12 |
|---|---|
| Billing NDC | 42291005512 |
| Package | 1 BOTTLE, PUMP in 1 BOX (42291-055-12) / 112 g in 1 BOTTLE, PUMP |
| Marketing Start Date | 2023-08-29 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |