Prescription drug · ANDA
Diclofenac Sodium 1.5% (Diclofenac sodium topical) NDC 68788-8084
Diclofenac sodium 16.05 mg/mL · Solution · Topical · Preferred Pharmaceuticals Inc.
NDC codes
FDA NDC DirectoryProduct information
- Brand name (proprietary)
- Diclofenac Sodium 1.5%
- Generic name (nonproprietary)
- diclofenac sodium topical
- Active ingredients
- Diclofenac sodium — 16.05 mg/mL
- Dosage form
- Solution
- Route
- Topical
- Labeler
- Preferred Pharmaceuticals Inc.NDC labeler code 68788
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 204132
- Marketing start
- Listing expires
- Other FDA classes
- Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)Decreased Prostaglandin Production (Physiologic effect)
- Identifiers
- Product ID 68788-8084_51b4bcee-b586-4476-8ce8-898537958b66SPL ID 51b4bcee-b586-4476-8ce8-898537958b66SPL set ID dbcd42cf-d44a-4d47-9149-66ffcf9a0587UNII QTG126297Q
- Pharmacologic class
- Nonsteroidal Anti-inflammatory Drug
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.
Product label
Current FDA label (SPL), effective . This label includes a boxed warning.
Indications (excerpt from the label)
Diclofenac sodium is indicated for the treatment of signs and symptoms of osteoarthritis of the knee(s) (1). Diclofenac sodium is indicated for the treatment of signs and symptoms of osteoarthritis of the knee(s) (1).
Excerpt only. Read the full label for complete information.
About NDC 68788-8084
- What is NDC 68788-8084?
- 68788-8084 is the product NDC for Diclofenac Sodium 1.5% (diclofenac sodium topical), Diclofenac sodium 16.05 mg/mL solution, listed with the FDA by Preferred Pharmaceuticals Inc..
- What drug is associated with this NDC?
- Diclofenac Sodium 1.5% (Diclofenac Sodium Topical).
- What is the active ingredient?
- Diclofenac sodium.
- Who is the labeler?
- Preferred Pharmaceuticals Inc., NDC labeler code 68788. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Diclofenac Sodium 1.5%?
- 3 other product NDCs are listed under this name. See all Diclofenac Sodium 1.5% NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Diclofenac Sodium 1.5% products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Diclofenac Sodium 1.5%diclofenac sodium topical | Diclofenac sodium 16.05 mg/mL | SolutionTopical | SOLA Pharmaceuticals | 70512-038 | 70512-0038-05 |
| Diclofenac Sodium 1.5%diclofenac sodium topical | Diclofenac sodium 16.05 mg/mL | SolutionTopical | Proficient Rx LP | 71205-640 | 71205-0640-15 |
| Diclofenac Sodium 1.5%diclofenac sodium topical | Diclofenac sodium 16.05 mg/mL | SolutionTopical | PHOENIX RX LLC | 85509-1038 | 85509-1038-01 |
Other NDCs under ANDA 204132
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 |
|---|---|---|---|---|
| Diclofenac Sodium | Diclofenac sodium 16.05 mg/mL | Solution/ dropsTransdermal | Proficient Rx LP | 63187-791 |
| Diclofenac Sodium | Diclofenac sodium 16.05 mg/mL | SolutionTopical | DIRECT RX | 72189-273 |
| Diclofenac Sodium | Diclofenac sodium 16.05 mg/mL | Solution/ dropsTransdermal | Asclemed USA, Inc. | 76420-134 |
| Diclofenac Sodium | Diclofenac sodium 16.05 mg/mL | SolutionTopical | Advanced Rx of Tennessee, LLC | 80425-0240 |
| Diclofenac Sodium 1.5%diclofenac sodium topical | Diclofenac sodium 16.05 mg/mL | SolutionTopical | SOLA Pharmaceuticals | 70512-038 |
| Diclofenac Sodium 1.5%diclofenac sodium topical | Diclofenac sodium 16.05 mg/mL | SolutionTopical | Proficient Rx LP | 71205-640 |
| Diclofenac Sodium 1.5%diclofenac sodium topical | Diclofenac sodium 16.05 mg/mL | SolutionTopical | PHOENIX RX LLC | 85509-1038 |