Diclofenac Sodium
- Product NDC
- 45865-260
- 11-digit product format
- 458650260
- Labeler code
- 45865
- Product ID
- 45865-260_1495ed53-048a-a465-e063-6394a90af68d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Diclofenac Sodium Topical
- Dosage form
- GEL
- Route
- TOPICAL
- Labeler
- Medsource Pharmaceuticals
- Application
- ANDA212351
- Marketing category
- ANDA
- Marketing start
- 2022-09-15
- 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
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 | 30 mg/g |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | QTG126297Q |
| Rxcui | 855642 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 45865-260-01 | Diclofenac Sodium | 100 g in 1 TUBE | GEL | 100 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 45865-260 | DICLOFENAC SODIUM (DICLOFENAC SODIUM TOPICAL) GEL [MEDSOURCE PHARMACEUTICALS] | 1 | Current NDC, 1 package rows | 20240328_1495ed53-0489-a465-e063-6394a90af68d.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 45865-260-01 | 45865026001 | 100 g in 1 TUBE (45865-260-01) | 100 g | 2023-07-07 | No | No | Current |