Diclofenac Sodium
- Product NDC
- 55700-591
- 11-digit product format
- 557000591
- Labeler code
- 55700
- Product ID
- 55700-591_05da3eba-6809-41fc-b02d-a357a57e4b09
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Diclofenac Sodium
- Dosage form
- SOLUTION
- Route
- TOPICAL
- Labeler
- Quality Care Products LLC
- Application
- ANDA202769
- Marketing category
- ANDA
- Marketing start
- 2018-03-09
- Marketing end
- 2028-10-19
- 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
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Diclofenac Sodium
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#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 55700-591-15 | Diclofenac Sodium | 1 in 1 CARTON | SOLUTION | 1 | | 5 |
| 55700-591-15 | Diclofenac Sodium | 150 mL in 1 BOTTLE | SOLUTION | 150 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 55700-591 | DICLOFENAC SODIUM (DICLOFENAC SODIUM) SOLUTION [QUALITY CARE PRODUCTS LLC] | 5 | Current NDC, Legacy NDC, 2 package rows | 20230302_94422b85-28ed-477f-853a-71d1d6cf17d5.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 55700-591-15 | 55700059115 | 1 BOTTLE in 1 CARTON (55700-591-15) / 150 mL in 1 BOTTLE | 1 bottle | 2018-03-09 | 2028-10-19 | No | No | Current |