Diclofenac Sodium
- Product NDC
- 82804-113
- 11-digit product format
- 828040113
- Labeler code
- 82804
- Product ID
- 82804-113_898558e7-17f8-40cd-9dfc-67ddd64a5a42
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Diclofenac Sodium
- Dosage form
- SOLUTION
- Route
- TOPICAL
- Labeler
- Proficient Rx LP
- Application
- ANDA208021
- Marketing category
- ANDA
- Marketing start
- 2024-02-19
- Substance
- DICLOFENAC SODIUM
- Active strength
- 20 mg/g
- 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
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| QTG126297Q | DICLOFENAC SODIUM | 15307-79-6 | DICLOFENAC SODIUM |
Packages
| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 82804-113-12 | 82804011312 | 1 BOTTLE, PUMP in 1 CARTON (82804-113-12) / 112 g in 1 BOTTLE, PUMP | 2024-07-05 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Diclofenac Sodium | Proficient Rx LP | 2024-07-01 | HUMAN PRESCRIPTION DRUG LABEL | 1 |