Diclofenac Sodium Gel
- Product NDC
- 72189-479
- 11-digit product format
- 721890479
- Labeler code
- 72189
- Product ID
- 72189-479_2c4e167d-2908-0703-e063-6394a90a9132
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Diclofenac Sodium Gel
- Dosage form
- GEL
- Route
- TOPICAL
- Labeler
- Direct_Rx
- Application
- ANDA210986
- Marketing category
- ANDA
- Marketing start
- 2023-05-30
- 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 Gel
- 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 |
|---|
| 72189-479-01 | Diclofenac Sodium Gel | 1 g in 1 TUBE | GEL | 1 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 72189-479 | DICLOFENAC SODIUM GEL GEL [DIRECT_RX] | 3 | Current NDC, 1 package rows | 20250123_fce9b3eb-ae79-a090-e053-6294a90ad20e.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 |
|---|
| 72189-479-01 | 72189047901 | 1 g in 1 TUBE (72189-479-01) | 1 g | 2023-05-30 | No | No | Current |