Diclofenac sodium
- Product NDC
- 42291-055
- 11-digit product format
- 422910055
- Labeler code
- 42291
- Product ID
- 42291-055_484c1f52-6419-1ce3-e063-6394a90aa297
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Diclofenac sodium
- Dosage form
- SOLUTION
- Route
- TOPICAL
- Labeler
- AvKARE
- Application
- ANDA212506
- Marketing category
- ANDA
- Marketing start
- 2023-08-29
- 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
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Diclofenac sodium
- Listing expiration
- 2027-12-31
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 |
|---|
| 42291-055-12 | Diclofenac sodium | 112 g in 1 BOTTLE, PUMP | SOLUTION | 112 | | 2 |
| 42291-055-12 | Diclofenac sodium | 1 in 1 BOX | SOLUTION | 1 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 42291-055 | DICLOFENAC SODIUM SOLUTION [AVKARE] | 1 | Current NDC, 2 package rows | 20230830_0416ce03-c345-9d9e-e063-6294a90ad940.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 42291-055-12 | 42291005512 | 1 BOTTLE, PUMP in 1 BOX (42291-055-12) / 112 g in 1 BOTTLE, PUMP | 2023-08-29 | No | No | Current |