Diclofenac Sodium
- Product NDC
- 85509-1369
- 11-digit product format
- 855091369
- Labeler code
- 85509
- Product ID
- 85509-1369_3e5608ff-9137-d9f8-e063-6294a90a5b9f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Diclofenac Sodium
- Dosage form
- SOLUTION
- Route
- TOPICAL
- Labeler
- PHOENIX RX LLC
- Application
- ANDA208098
- Marketing category
- ANDA
- Marketing start
- 2023-05-31
- 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
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Diclofenac Sodium
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| DICLOFENAC SODIUM | 20 mg/g |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | QTG126297Q |
| Rxcui | 1487074 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 85509-1369-1 | Diclofenac Sodium | 1 in 1 CARTON | SOLUTION | 1 | | 2 |
| 85509-1369-1 | Diclofenac Sodium | 112 g in 1 BOTTLE, PUMP | SOLUTION | 112 | | 2 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 85509-1369-1 | 85509136901 | 1 BOTTLE, PUMP in 1 CARTON (85509-1369-1) / 112 g in 1 BOTTLE, PUMP | 2025-09-05 | No | No | Historical |