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NDC 00536-1294-31 Diclofenac sodium 10 mg/g Details
Diclofenac sodium 10 mg/g
Diclofenac sodium is a TOPICAL GEL in the HUMAN OTC DRUG category. It is labeled and distributed by Rugby Laboratories, Inc.. The primary component is DICLOFENAC SODIUM.
MedlinePlus Drug Summary
Diclofenac topical gel (Solaraze) is used to treat actinic keratosis (flat, scaly growths on the skin caused by too much sun exposure). Diclofenac is in a class of medications called nonsteroidal anti-inflammatory drugs (NSAIDs). The way diclofenac gel works to treat actinic keratosis is not known. Diclofenac is also available as a liquid (Pennsaid) and a gel (Voltaren) that are applied to the skin to treat arthritis pain. This monograph only gives information about diclofenac gel (Solaraze) for actinic keratosis. If you are using either of the products for osteoarthritis, read the monograph entitled diclofenac topical (osteoarthritis pain).
Related Packages: 00536-1294-31Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Diclofenac Topical (actinic keratosis)
Product Information
| NDC | 00536-1294 |
|---|---|
| Product ID | 0536-1294_958908f7-98d7-4b77-97fb-34106b11abd5 |
| Associated GPIs | 90210030304020 |
| GCN Sequence Number | 018293 |
| GCN Sequence Number Description | diclofenac sodium GEL (GRAM) 1 % TOPICAL |
| HIC3 | Q5E |
| HIC3 Description | TOPICAL ANTI-INFLAMMATORY, NSAIDS |
| GCN | 45680 |
| 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 OTC DRUG |
| Dosage Form | GEL |
| Route | TOPICAL |
| Active Ingredient Strength | 10 |
| Active Ingredient Units | mg/g |
| Substance Name | DICLOFENAC SODIUM |
| Labeler Name | Rugby Laboratories, Inc. |
| 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 | ANDA208077 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 00536-1294-31 (00536129431)
| NDC Package Code | 0536-1294-31 |
|---|---|
| Billing NDC | 00536129431 |
| Package | 1 TUBE in 1 CARTON (0536-1294-31) / 150 g in 1 TUBE |
| Marketing Start Date | 2020-09-14 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |