Diclofenac Sodium
- Product NDC
- 76420-919
- 11-digit product format
- 764200919
- Labeler code
- 76420
- Product ID
- 76420-919_2d9db307-1bf0-ed7f-e063-6294a90a0c53
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Diclofenac Sodium
- Dosage form
- SOLUTION
- Route
- TOPICAL
- Labeler
- Asclemed USA, Inc.
- Application
- ANDA203818
- Marketing category
- ANDA
- Marketing start
- 2014-11-26
- 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
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 |
|---|
| 76420-919-02 | 76420091902 | 1 BOTTLE, DROPPER in 1 CARTON (76420-919-02) / 150 mL in 1 BOTTLE, DROPPER | 2025-02-08 | No | No | Historical |
| 76420-919-04 | 76420091904 | 1 BOTTLE, DROPPER in 1 CARTON (76420-919-04) / 60 mL in 1 BOTTLE, DROPPER | 2025-02-08 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Diclofenac Sodium | Asclemed USA, Inc. | ASCLEMED USA INC. DBA ENOVACHEM | 2025-02-08 | HUMAN PRESCRIPTION DRUG LABEL | 1 |