Diclofenac Sodium
- Product NDC
- 85509-1103
- 11-digit product format
- 855091103
- Labeler code
- 85509
- Product ID
- 85509-1103_43923c68-87ab-1ab7-e063-6394a90adf7a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Diclofenac Sodium
- Dosage form
- TABLET, DELAYED RELEASE
- Route
- ORAL
- Labeler
- PHOENIX RX LLC
- Application
- ANDA075185
- Marketing category
- ANDA
- Marketing start
- 1998-11-13
- 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
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Diclofenac Sodium
- Brand name suffix
- Delayed Release
- Listing expiration
- 2026-12-31
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 |
|---|
| 85509-1103-3 | Diclofenac SodiumDelayed Release | 30 in 1 BOTTLE, PLASTIC | TABLET, DELAYED RELEASE | 30 | | 1 |
| 85509-1103-6 | Diclofenac SodiumDelayed Release | 60 in 1 BOTTLE, PLASTIC | TABLET, DELAYED RELEASE | 60 | | 1 |
| 85509-1103-9 | Diclofenac SodiumDelayed Release | 90 in 1 BOTTLE, PLASTIC | TABLET, DELAYED RELEASE | 90 | | 1 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 85509-1103-3 | 85509110303 | 30 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (85509-1103-3) | 2025-11-14 | No | No | Historical |
| 85509-1103-6 | 85509110306 | 60 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (85509-1103-6) | 2025-11-14 | No | No | Historical |
| 85509-1103-9 | 85509110309 | 90 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (85509-1103-9) | 2025-11-14 | No | No | Historical |