DICLOFENAC SODIUM
- Product NDC
- 62379-401
- 11-digit product format
- 623790401
- Labeler code
- 62379
- Product ID
- 62379-401_14062028-4023-9b1c-e063-6394a90a1f53
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- diclofenac sodium topical gel, 1%
- Dosage form
- GEL
- Route
- TOPICAL
- Labeler
- Simple Diagnostics
- Application
- ANDA210986
- Marketing category
- ANDA
- Marketing start
- 2024-03-13
- 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 |
|---|
| 62379-401-01 | DICLOFENAC SODIUM | 100 g in 1 TUBE | GEL | 100 | | 8 |
| 62379-401-02 | DICLOFENAC SODIUM | 1 in 1 CARTON | GEL | 1 | | 8 |
| 62379-401-03 | DICLOFENAC SODIUM | 150 g in 1 TUBE | GEL | 150 | | 8 |
| 62379-401-04 | DICLOFENAC SODIUM | 1 in 1 CARTON | GEL | 1 | | 8 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 62379-401 | DICLOFENAC SODIUM (DICLOFENAC SODIUM TOPICAL GEL, 1%) GEL [SIMPLE DIAGNOSTICS] | 8 | Current NDC, 4 package rows | 20240321_13925cd5-e121-80d2-e063-6394a90af9a9.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 |
|---|
| 62379-401-01 | 62379040101 | 100 g in 1 TUBE | 100 g | | | | Historical |
| 62379-401-02 | 62379040102 | 1 TUBE in 1 CARTON (62379-401-02) / 100 g in 1 TUBE (62379-401-01) | 1 tube | 2024-03-13 | No | No | Historical |
| 62379-401-03 | 62379040103 | 150 g in 1 TUBE | 150 g | | | | Historical |
| 62379-401-04 | 62379040104 | 1 TUBE in 1 CARTON (62379-401-04) / 150 g in 1 TUBE (62379-401-03) | 1 tube | 2024-03-13 | No | No | Historical |