Diclofenac Sodium
- Product NDC
- 82804-160
- 11-digit product format
- 828040160
- Labeler code
- 82804
- Product ID
- 82804-160_ba4677e4-00f8-44f6-a69b-e88ca28f6b2b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Diclofenac Sodium
- Dosage form
- SOLUTION
- Route
- TOPICAL
- Labeler
- Proficient Rx LP
- Application
- ANDA213040
- Marketing category
- ANDA
- Marketing start
- 2024-06-01
- Substance
- DICLOFENAC SODIUM
- Active strength
- 20 mg/g
- 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
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| DICLOFENAC SODIUM | 20 mg/g |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | QTG126297Q |
| Rxcui | 1487074 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 82804-160-12 | Diclofenac Sodium | 112 g in 1 BOTTLE | SOLUTION | 112 | | 1 |
| 82804-160-12 | Diclofenac Sodium | 1 in 1 CARTON | SOLUTION | 1 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 82804-160 | DICLOFENAC SODIUM SOLUTION [PROFICIENT RX LP] | 1 | Current NDC, 2 package rows | 20241115_ba4677e4-00f8-44f6-a69b-e88ca28f6b2b.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 82804-160-12 | 82804016012 | 1 BOTTLE in 1 CARTON (82804-160-12) / 112 g in 1 BOTTLE | 1 bottle | 2024-11-11 | No | No | Current |