Diclofenac Sodium
- Product NDC
- 85766-010
- 11-digit product format
- 857660010
- Labeler code
- 85766
- Product ID
- 85766-010_49eec2b4-4e7e-065f-e063-6394a90af76f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Diclofenac Sodium
- Dosage form
- TABLET, DELAYED RELEASE
- Route
- ORAL
- Labeler
- Sportpharm LLC
- Application
- ANDA077863
- Marketing category
- ANDA
- Marketing start
- 2008-08-19
- Substance
- DICLOFENAC SODIUM
- Active strength
- 75 mg/1
- 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 | 75 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | QTG126297Q |
| Rxcui | 855926 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 85766-010-01 | Diclofenac Sodium | 100 in 1 BOTTLE | TABLET, DELAYED RELEASE | 100 | | 4 |
| 85766-010-14 | Diclofenac Sodium | 14 in 1 BOTTLE | TABLET, DELAYED RELEASE | 14 | | 4 |
| 85766-010-30 | Diclofenac Sodium | 30 in 1 BOTTLE | TABLET, DELAYED RELEASE | 30 | | 4 |
| 85766-010-60 | Diclofenac Sodium | 60 in 1 BOTTLE, PLASTIC | TABLET, DELAYED RELEASE | 60 | | 4 |
| 85766-010-90 | Diclofenac Sodium | 90 in 1 BOTTLE | TABLET, DELAYED RELEASE | 90 | | 4 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 85766-010-01 | 85766001001 | 100 TABLET, DELAYED RELEASE in 1 BOTTLE (85766-010-01) | 2025-06-18 | No | No | Current |
| 85766-010-14 | 85766001014 | 14 TABLET, DELAYED RELEASE in 1 BOTTLE (85766-010-14) | 2025-09-24 | No | No | Current |
| 85766-010-30 | 85766001030 | 30 TABLET, DELAYED RELEASE in 1 BOTTLE (85766-010-30) | 2025-06-18 | No | No | Current |
| 85766-010-60 | 85766001060 | 60 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (85766-010-60) | 2025-06-18 | No | No | Current |
| 85766-010-90 | 85766001090 | 90 TABLET, DELAYED RELEASE in 1 BOTTLE (85766-010-90) | 2025-06-18 | No | No | Current |