Diclofenac Epolamine
- Product NDC
- 82347-0405
- 11-digit product format
- 823470405
- Labeler code
- 82347
- Product ID
- 82347-0405_41a96431-3fd8-a73e-e063-6294a90a5ec5
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Diclofenac Epolamine
- Dosage form
- SYSTEM
- Route
- TOPICAL
- Labeler
- YARAL Pharma Inc.
- Application
- NDA021234
- Marketing category
- NDA AUTHORIZED GENERIC
- Marketing start
- 2022-11-18
- Substance
- DICLOFENAC EPOLAMINE
- Active strength
- .013 g/1
- 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 Epolamine
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| DICLOFENAC EPOLAMINE | .013 g/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | X5F8EKL9ZG |
| Rxcui | 855626 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 82347-0405-4 | Diclofenac Epolamine | 5 in 1 POUCH | SYSTEM | 5 | | 8 |
| 82347-0405-5 | Diclofenac Epolamine | 6 in 1 CARTON | SYSTEM | 6 | | 8 |
| 82347-0405-6 | Diclofenac Epolamine | 3 in 1 CARTON | SYSTEM | 3 | | 8 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 82347-0405 | DICLOFENAC EPOLAMINE SYSTEM [YARAL PHARMA INC.] | 7 | Current NDC, Legacy NDC, 3 package rows | 20241201_2d9bfacc-1b0c-4fab-b949-cd0c914089f9.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 |
|---|
| 82347-0405-4 | 82347040504 | 5 in 1 POUCH | | | | | | Historical |
| 82347-0405-5 | 82347040505 | 6 POUCH in 1 CARTON (82347-0405-5) / 5 SYSTEM in 1 POUCH (82347-0405-4) | 6 pouch | 2022-11-18 | 0000-00-00 | No | No | Current |
| 82347-0405-6 | 82347040506 | 3 POUCH in 1 CARTON (82347-0405-6) / 5 SYSTEM in 1 POUCH (82347-0405-4) | 3 pouch | 2025-01-15 | | No | No | Current |