diclofenac epolamine
- Product NDC
- 0093-3727
- 11-digit product format
- 000933727
- Labeler code
- 0093
- Product ID
- 0093-3727_47a76d8a-64d3-1948-e063-6294a90aab74
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- diclofenac epolamine
- Dosage form
- SYSTEM
- Route
- TOPICAL
- Labeler
- Teva Pharmaceuticals USA Inc.
- Application
- NDA021234
- Marketing category
- NDA AUTHORIZED GENERIC
- Marketing start
- 2020-05-01
- 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
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- diclofenac epolamine
- Listing expiration
- 2027-12-31
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 |
|---|
| 0093-3727-50 | diclofenac epolamine | 5 in 1 POUCH | SYSTEM | 5 | | 10 |
| 0093-3727-55 | diclofenac epolamine | 6 in 1 CARTON | SYSTEM | 6 | | 10 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0093-3727 | DICLOFENAC EPOLAMINE SYSTEM [TEVA PHARMACEUTICALS USA INC.] | 9 | Current NDC, Legacy NDC, 2 package rows | 20241201_d7bfe17d-e88e-4792-bfba-cea56ed96c3b.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 |
|---|
| 0093-3727-50 | 00093372750 | 5 in 1 POUCH | | | | | | Historical |
| 0093-3727-55 | 00093372755 | 6 POUCH in 1 CARTON (0093-3727-55) / 5 SYSTEM in 1 POUCH (0093-3727-50) | 6 pouch | 2020-05-01 | 0000-00-00 | No | No | Current |