DICLOFENAC SODIUM
- Product NDC
- 76420-132
- 11-digit product format
- 764200132
- Labeler code
- 76420
- Product ID
- 76420-132_b2dde8d1-d0df-d7c2-e053-2995a90a2ed3
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- diclofenac sodium
- Dosage form
- GEL
- Route
- TOPICAL
- Labeler
- Asclemed USA, Inc.
- Application
- ANDA208301
- Marketing category
- ANDA
- Marketing start
- 2016-09-13
- Substance
- DICLOFENAC SODIUM
- Active strength
- 30 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
Packages
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 76420-132-01 | 76420013201 | 100 g in 1 TUBE (76420-132-01) | 100 g | 2020-10-30 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| DICLOFENAC SODIUM GEL, 3% | Asclemed USA, Inc. | ASCLEMED USA INC. DBA ENOVACHEM | 2020-10-30 | HUMAN PRESCRIPTION DRUG LABEL | 1 |