Diclofenac Sodium
- Product NDC
- 58602-609
- 11-digit product format
- 586020609
- Labeler code
- 58602
- Product ID
- 58602-609_2a599579-b2b0-4423-8e30-fe04bf815870
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Diclofenac Sodium
- Dosage form
- GEL
- Route
- TOPICAL
- Labeler
- Aurohealth LLC
- Application
- ANDA204306
- Marketing category
- ANDA
- Marketing start
- 2023-08-11
- Substance
- DICLOFENAC SODIUM
- Active strength
- 10 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 | 10 mg/g |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | QTG126297Q |
| Rxcui | 855633 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 58602-609-07 | Diclofenac Sodium | 1 in 1 CARTON | GEL | 1 | | 1 |
| 58602-609-07 | 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 |
|---|
| 58602-609 | DICLOFENAC SODIUM GEL [AUROHEALTH LLC] | 1 | Current NDC, 2 package rows | 20230820_2a599579-b2b0-4423-8e30-fe04bf815870.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 |
|---|
| 58602-609-07 | 58602060907 | 1 TUBE in 1 CARTON (58602-609-07) / 100 g in 1 TUBE | 1 tube | 2023-08-11 | No | No | Historical |