Diclofenac
- Product NDC
- 59390-149
- 11-digit product format
- 593900149
- Labeler code
- 59390
- Product ID
- 59390-149_0561ff06-43b4-493e-93f7-b778fc829036
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Diclofenac Sodium
- Dosage form
- SOLUTION/ DROPS
- Route
- OPHTHALMIC
- Labeler
- Altaire Pharmaceuticals Inc.
- Application
- ANDA203383
- Marketing category
- ANDA
- Marketing start
- 2015-11-16
- 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
- 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#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 59390-149-02 | Diclofenac | 2.5 mL in 1 BOTTLE, DROPPER | SOLUTION/ DROPS | 2.5 | | 6 |
| 59390-149-02 | Diclofenac | 1 in 1 CARTON | SOLUTION/ DROPS | 1 | | 6 |
| 59390-149-05 | Diclofenac | 1 in 1 CARTON | SOLUTION/ DROPS | 1 | | 6 |
| 59390-149-05 | Diclofenac | 5 mL in 1 BOTTLE, DROPPER | SOLUTION/ DROPS | 5 | | 6 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 59390-149 | DICLOFENAC (DICLOFENAC SODIUM) SOLUTION/ DROPS [ALTAIRE PHARMACEUTICALS INC.] | 6 | Current NDC, Legacy NDC, 4 package rows | 20221206_5372866a-dab3-45c8-8c2a-755ca36c1791.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 59390-149-02 | 59390014902 | 1 BOTTLE, DROPPER in 1 CARTON (59390-149-02) / 2.5 mL in 1 BOTTLE, DROPPER | 2015-11-16 | 0000-00-00 | No | No | Current |
| 59390-149-05 | 59390014905 | 1 BOTTLE, DROPPER in 1 CARTON (59390-149-05) / 5 mL in 1 BOTTLE, DROPPER | 2015-11-16 | 0000-00-00 | No | No | Current |