DICLOFENAC SODIUM
- Product NDC
- 43598-885
- 11-digit product format
- 435980885
- Labeler code
- 43598
- Product ID
- 43598-885_0b8a2c28-1b4b-0ace-eff9-255a1c2dab82
- 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
- 2020-12-14
- 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 Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 43598-885 | DICLOFENAC SODIUM (DICLOFENAC SODIUM TOPICAL GEL, 1%) GEL [DR. REDDY'S LABORATORIES INC.] | 5 | Current NDC, Legacy NDC | 20241203_c88b2512-0255-658d-252a-c006275159b0.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 |
|---|
| 43598-885-10 | 43598088510 | 1 TUBE in 1 CARTON (43598-885-10) / 100 g in 1 TUBE | 1 tube | 2020-12-14 | 0000-00-00 | No | No | Current |
| 43598-885-15 | 43598088515 | 1 TUBE in 1 CARTON (43598-885-15) / 150 g in 1 TUBE | 1 tube | 2021-01-31 | 0000-00-00 | No | No | Current |
| 43598-885-21 | 43598088521 | 2 TUBE in 1 CARTON (43598-885-21) / 100 g in 1 TUBE | 2 tube | 2022-01-15 | 0000-00-00 | No | No | Current |
| 43598-885-50 | 43598088550 | 1 TUBE in 1 CARTON (43598-885-50) / 50 g in 1 TUBE | 1 tube | 2021-01-31 | 0000-00-00 | No | No | Current |