Diclofenac Sodium
- Product NDC
- 52959-987
- 11-digit product format
- 529590987
- Labeler code
- 52959
- Product ID
- 52959-987_1fb5dcde-d854-4df6-8fc7-35affe0adc11
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Diclofenac Sodium
- Dosage form
- SOLUTION/ DROPS
- Route
- OPHTHALMIC
- Labeler
- H.J. Harkins Company, Inc.
- Application
- ANDA078792
- Marketing category
- ANDA
- Marketing start
- 2007-12-28
- Marketing end
- 0000-00-00
- Substance
- DICLOFENAC SODIUM
- Active strength
- 1 mg/mL
- Pharmacologic classes
- Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC]
- NDC exclude flag
- E
- Listing certified through
- 2017-12-31
- Current FDA listing
- Historical FDA.report record
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 |
|---|
| 52959-987-05 | Diclofenac Sodium | 1 in 1 CARTON | SOLUTION/ DROPS | 1 | | 1 |
| 52959-987-05 | Diclofenac Sodium | 5 mL in 1 BOTTLE, DROPPER | SOLUTION/ DROPS | 5 | | 1 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| DICLOFENAC SODIUM | ACTIVE INGREDIENT | QTG126297Q | DICLOFENAC SODIUM SOLUTION/ DROPS [H.J. HARKINS COMPANY, INC.] | 1 | |
| DICLOFENAC | ACTIVE MOIETY | 144O8QL0L1 | DICLOFENAC SODIUM SOLUTION/ DROPS [H.J. HARKINS COMPANY, INC.] | 1 | |
| BORIC ACID | INACTIVE INGREDIENT | R57ZHV85D4 | DICLOFENAC SODIUM SOLUTION/ DROPS [H.J. HARKINS COMPANY, INC.] | 1 | |
| EDETATE DISODIUM | INACTIVE INGREDIENT | 7FLD91C86K | DICLOFENAC SODIUM SOLUTION/ DROPS [H.J. HARKINS COMPANY, INC.] | 1 | |
| POLYOXYL 35 CASTOR OIL | INACTIVE INGREDIENT | 6D4M1DAL6O | DICLOFENAC SODIUM SOLUTION/ DROPS [H.J. HARKINS COMPANY, INC.] | 1 | |
| SORBIC ACID | INACTIVE INGREDIENT | X045WJ989B | DICLOFENAC SODIUM SOLUTION/ DROPS [H.J. HARKINS COMPANY, INC.] | 1 | |
| TROMETHAMINE | INACTIVE INGREDIENT | 023C2WHX2V | DICLOFENAC SODIUM SOLUTION/ DROPS [H.J. HARKINS COMPANY, INC.] | 1 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | DICLOFENAC SODIUM SOLUTION/ DROPS [H.J. HARKINS COMPANY, INC.] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 52959-987 | DICLOFENAC SODIUM SOLUTION/ DROPS [H.J. HARKINS COMPANY, INC.] | 1 | Legacy NDC, 2 package rows | 20111205_41c80e79-36fd-4b90-bae1-55d6042c3ca2.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Status |
|---|
| 52959-987-05 | 52959098705 | 1 in 1 CARTON | Historical |