Diclofenac Sodium
- Product NDC
- 72189-527
- 11-digit product format
- 721890527
- Labeler code
- 72189
- Product ID
- 72189-527_2c4e847a-ba5c-1ee0-e063-6394a90aa9ba
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Diclofenac Sodium
- Dosage form
- SOLUTION
- Route
- TOPICAL
- Labeler
- Direct_Rx
- Application
- ANDA206116
- Marketing category
- ANDA
- Marketing start
- 2023-12-11
- Substance
- DICLOFENAC SODIUM
- Active strength
- 16.05 mg/mL
- 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 | 16.05 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | QTG126297Q |
| Rxcui | 857700 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 72189-527-05 | Diclofenac Sodium | 150 mL in 1 BOTTLE | SOLUTION | 150 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 72189-527 | DICLOFENAC SODIUM SOLUTION [DIRECT_RX] | 2 | Current NDC, 1 package rows | 20250207_0c41977f-8dad-1d26-e063-6294a90a9b22.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 |
|---|
| 72189-527-05 | 72189052705 | 150 mL in 1 BOTTLE (72189-527-05) | 150 ml | 2023-12-11 | No | No | Historical |