DICLOFENAC SODIUM
- Product NDC
- 21922-044
- 11-digit product format
- 219220044
- Labeler code
- 21922
- Product ID
- 21922-044_fac5ba8a-cf2d-4cba-8a98-55fc36e554ca
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- diclofenac sodium topical gel, 1%
- Dosage form
- GEL
- Route
- TOPICAL
- Labeler
- Encube Ethicals, Inc.
- Application
- ANDA210986
- Marketing category
- ANDA
- Marketing start
- 2020-08-11
- 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#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 21922-044 | DICLOFENAC SODIUM (DICLOFENAC SODIUM TOPICAL GEL, 1%) GEL [ENCUBE ETHICALS PRIVATE LIMITED] | 6 | Current NDC, Legacy NDC, 8 package rows | 20250122_6e8c45e1-8cd4-4ff7-a758-f9d2ed37e593.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 |
|---|
| 21922-044-09 | 21922004409 | 1 TUBE in 1 CARTON (21922-044-09) / 100 g in 1 TUBE | 1 tube | 2020-08-11 | 0000-00-00 | No | No | Current |
| 21922-044-14 | 21922004414 | 1 TUBE in 1 CARTON (21922-044-14) / 50 g in 1 TUBE | 1 tube | 2021-02-01 | 0000-00-00 | No | No | Current |
| 21922-044-25 | 21922004425 | 1 TUBE in 1 CARTON (21922-044-25) / 20 g in 1 TUBE | 1 tube | 2021-02-01 | 0000-00-00 | No | No | Current |
| 21922-044-26 | 21922004426 | 1 TUBE in 1 CARTON (21922-044-26) / 150 g in 1 TUBE | 1 tube | 2021-02-01 | 0000-00-00 | No | No | Current |
| 21922-044-29 | 21922004429 | 1 TUBE in 1 CARTON (21922-044-29) > 100 g in 1 TUBE | 1 tube | 2021-07-24 | 0000-00-00 | No | No | Current |