DICLOFENAC SODIUM
- Product NDC
- 43598-977
- 11-digit product format
- 435980977
- Labeler code
- 43598
- Product ID
- 43598-977_affe6a89-16fb-8b78-d0db-1f7f8a818ea7
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- diclofenac sodium topical gel, 1%
- Dosage form
- GEL
- Route
- TOPICAL
- Labeler
- Dr. Reddy's Laboratories Inc.
- Application
- ANDA210986
- Marketing category
- ANDA
- Marketing start
- 2020-09-14
- 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 |
|---|
| 43598-977-10 | VennGel II | 100 g in 1 TUBE | GEL | 100 g | 10 mg in 1g | 2 |
| 43598-977-10 | VennGel II | 1 in 1 CARTON | GEL | | 10 mg in 1g | 2 |
| 43598-977-10 | Diclolidol Kit | 1 in 1 CARTON | GEL | | 10 mg in 1g | 1 |
| 43598-977-10 | Diclolidol Kit | 100 g in 1 TUBE | GEL | 1 g in 100 | 10 mg in 1g | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 43598-977 | DICLOFENAC SODIUM (DICLOFENAC SODIUM TOPICAL GEL, 1%) GEL [DR. REDDY'S LABORATORIES INC.] | 6 | Current NDC, Legacy NDC | 20250316_03abebd6-426a-9d05-3dff-196477389430.zip |
| 43598-977 | VENNGEL II (DICLOFENAC SODIUM, ISOPROPYL ALCOHOL) KIT [PURETEK CORPORATION] | 2 | Current NDC, Legacy NDC | 20250303_2e70d8e9-9678-2d51-e063-6294a90aca64.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 43598-977-05 | 43598097705 | 1 TUBE in 1 CARTON (43598-977-05) / 50 g in 1 TUBE | 1 tube | 2021-01-31 | 0000-00-00 | No | No | Current |
| 43598-977-10 | 43598097710 | 1 TUBE in 1 CARTON (43598-977-10) / 100 g in 1 TUBE | 1 tube | 2020-09-14 | 0000-00-00 | No | No | Current |
| 43598-977-15 | 43598097715 | 1 TUBE in 1 CARTON (43598-977-15) / 150 g in 1 TUBE | 1 tube | 2021-01-31 | 0000-00-00 | No | No | Current |
| 43598-977-21 | 43598097721 | 2 TUBE in 1 CARTON (43598-977-21) / 100 g in 1 TUBE | 2 tube | 2025-05-05 | | No | No | Historical |
| 43598-977-22 | 43598097722 | 1 TUBE in 1 CARTON (43598-977-22) / 20 g in 1 TUBE | 1 tube | 2021-03-31 | 0000-00-00 | No | No | Current |