Diclofenac Sodium
- Product NDC
- 61314-014
- 11-digit product format
- 613140014
- Labeler code
- 61314
- Product ID
- 61314-014_202278f8-31f7-4c24-ae96-8065430d6a7d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Diclofenac Sodium
- Dosage form
- SOLUTION
- Route
- OPHTHALMIC
- Labeler
- Sandoz Inc
- Application
- ANDA078031
- Marketing category
- ANDA
- Marketing start
- 2008-02-14
- Substance
- DICLOFENAC SODIUM
- Active strength
- 1 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 | 1 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | QTG126297Q |
| Rxcui | 854801 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 61314-014-05 | Diclofenac Sodium | 5 mL in 1 BOTTLE | SOLUTION | 5 | | 7 |
| 61314-014-05 | Diclofenac Sodium | 1 in 1 CARTON | SOLUTION | 1 | | 7 |
| 61314-014-25 | Diclofenac Sodium | 1 in 1 CARTON | SOLUTION | 1 | | 7 |
| 61314-014-25 | Diclofenac Sodium | 2.5 mL in 1 BOTTLE | SOLUTION | 2.5 | | 7 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 61314-014 | DICLOFENAC SODIUM SOLUTION [SANDOZ INC] | 7 | Current NDC, Legacy NDC, 4 package rows | 20241206_52d22a6b-3acd-4694-9df5-8cfa9cc2bb2b.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 |
|---|
| 61314-014-05 | 61314001405 | 1 BOTTLE in 1 CARTON (61314-014-05) / 5 mL in 1 BOTTLE | 1 bottle | 2018-02-14 | 0000-00-00 | No | No | Current |
| 61314-014-25 | 61314001425 | 1 BOTTLE in 1 CARTON (61314-014-25) / 2.5 mL in 1 BOTTLE | 1 bottle | 2018-02-14 | 0000-00-00 | No | No | Current |