Diclofenac Sodium
- Product NDC
- 71335-2543
- 11-digit product format
- 713352543
- Labeler code
- 71335
- Product ID
- 71335-2543_a080cd82-7866-49c6-91a9-722e38dba3a4
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Diclofenac Sodium
- Dosage form
- TABLET, DELAYED RELEASE
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA090066
- Marketing category
- ANDA
- Marketing start
- 2010-12-31
- Substance
- DICLOFENAC SODIUM
- Active strength
- 50 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
openFDA Listing Details
- Product ID
- 71335-2543_a080cd82-7866-49c6-91a9-722e38dba3a4
- SPL ID
- a080cd82-7866-49c6-91a9-722e38dba3a4
- Product type
- HUMAN PRESCRIPTION DRUG
- Finished product
- Yes
- Brand name base
- Diclofenac Sodium
- Generic name
- Diclofenac Sodium
- Dosage form
- TABLET, DELAYED RELEASE
- Route
- ORAL
- Marketing start
- 2010-12-31
- Marketing category
- ANDA
- Application number
- ANDA090066
- Pharmacologic classes
- Anti-Inflammatory Agents; Non-Steroidal [CS]; Cyclooxygenase Inhibitors [MoA]; Decreased Prostaglandin Production [PE]; Nonsteroidal Anti-inflammatory Drug [EPC]
- Listing expiration
- 2026-12-31
openFDA Active Ingredients
| Ingredient | Strength |
|---|
| DICLOFENAC SODIUM | 50 mg/1 |
openFDA Harmonized Identifiers
| Field | Values |
|---|
| Unii | QTG126297Q |
| Rxcui | 855906 |
| Spl Set Id | af480e78-ff65-4709-af26-c430aefb77d6 |
| Manufacturer Name | Bryant Ranch Prepack |
openFDA Package Details
| Package NDC | Description | Marketing start | Sample |
|---|
| 71335-2543-1 | 30 TABLET, DELAYED RELEASE in 1 BOTTLE (71335-2543-1) | 2025-01-08 | No |
| 71335-2543-2 | 60 TABLET, DELAYED RELEASE in 1 BOTTLE (71335-2543-2) | 2025-01-08 | No |
| 71335-2543-3 | 90 TABLET, DELAYED RELEASE in 1 BOTTLE (71335-2543-3) | 2025-01-08 | No |
| 71335-2543-4 | 120 TABLET, DELAYED RELEASE in 1 BOTTLE (71335-2543-4) | 2025-01-08 | No |
| 71335-2543-5 | 20 TABLET, DELAYED RELEASE in 1 BOTTLE (71335-2543-5) | 2025-01-08 | No |
| 71335-2543-6 | 1000 TABLET, DELAYED RELEASE in 1 BOTTLE (71335-2543-6) | 2025-01-08 | No |
| 71335-2543-7 | 14 TABLET, DELAYED RELEASE in 1 BOTTLE (71335-2543-7) | 2025-01-08 | No |
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| QTG126297Q | DICLOFENAC SODIUM | 15307-79-6 | DICLOFENAC SODIUM |
Packages
| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 71335-2543-1 | 71335254301 | 30 TABLET, DELAYED RELEASE in 1 BOTTLE (71335-2543-1) | 2025-01-08 | No | No | Historical |
| 71335-2543-2 | 71335254302 | 60 TABLET, DELAYED RELEASE in 1 BOTTLE (71335-2543-2) | 2025-01-08 | No | No | Historical |
| 71335-2543-3 | 71335254303 | 90 TABLET, DELAYED RELEASE in 1 BOTTLE (71335-2543-3) | 2025-01-08 | No | No | Historical |
| 71335-2543-4 | 71335254304 | 120 TABLET, DELAYED RELEASE in 1 BOTTLE (71335-2543-4) | 2025-01-08 | No | No | Historical |
| 71335-2543-5 | 71335254305 | 20 TABLET, DELAYED RELEASE in 1 BOTTLE (71335-2543-5) | 2025-01-08 | No | No | Historical |
| 71335-2543-6 | 71335254306 | 1000 TABLET, DELAYED RELEASE in 1 BOTTLE (71335-2543-6) | 2025-01-08 | No | No | Historical |
| 71335-2543-7 | 71335254307 | 14 TABLET, DELAYED RELEASE in 1 BOTTLE (71335-2543-7) | 2025-01-08 | No | No | Historical |