Diclofenac Sodium 1.5%
- Product NDC
- 68788-8084
- 11-digit product format
- 687888084
- Labeler code
- 68788
- Product ID
- 68788-8084_51b4bcee-b586-4476-8ce8-898537958b66
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Diclofenac Sodium Topical
- Dosage form
- SOLUTION
- Route
- TOPICAL
- Labeler
- Preferred Pharmaceuticals Inc.
- Application
- ANDA204132
- Marketing category
- ANDA
- Marketing start
- 2021-10-05
- Substance
- DICLOFENAC SODIUM
- Active strength
- 16.05 mg/mL
- Pharmacologic classes
- Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Prostaglandin Production [PE], Nonsteroidal Anti-inflammatory Drug [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Diclofenac Sodium 1.5%
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| DICLOFENAC SODIUM | 16.05 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | QTG126297Q |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 68788-8084-1 | 68788808401 | 1 BOTTLE in 1 CARTON (68788-8084-1) > 150 mL in 1 BOTTLE | 1 bottle | 2021-10-05 | 0000-00-00 | No | No | Current |