Diclofenac Sodium
- Product NDC
- 76282-103
- 11-digit product format
- 762820103
- Labeler code
- 76282
- Product ID
- 76282-103_6fc74e92-7f37-41e7-aa8b-8fd0275a57c9
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Diclofenac sodium
- Dosage form
- GEL
- Route
- TOPICAL
- Labeler
- EXELAN PHARMACEUTICALS INC.
- Application
- ANDA209903
- Marketing category
- ANDA
- Marketing start
- 2024-07-30
- Substance
- DICLOFENAC SODIUM
- Active strength
- 10 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 | 10 mg/g |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | QTG126297Q |
| Rxcui | 855633 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 76282-103-39 | Diclofenac Sodium | 100 g in 1 TUBE | GEL | 100 | | 2 |
| 76282-103-39 | Diclofenac Sodium | 1 in 1 CARTON | GEL | 1 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 76282-103 | DICLOFENAC SODIUM GEL [EXELAN PHARMACEUTICALS INC.] | 2 | Current NDC, 2 package rows | 20240805_be25c19e-cbea-4f87-a581-9f0d350e5adf.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 |
|---|
| 76282-103-39 | 76282010339 | 1 TUBE in 1 CARTON (76282-103-39) / 100 g in 1 TUBE | 1 tube | 2024-07-30 | No | No | Current |