FENOPRON
- Product NDC
- 61825-311
- 11-digit product format
- 618250311
- Labeler code
- 61825
- Product ID
- 61825-311_1ad61a67-8758-4f2f-b7d5-f00f62ea69aa
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- FENOPROFEN CALCIUM
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Galt Pharmaceuticals, LLC
- Application
- ANDA214475
- Marketing category
- ANDA
- Marketing start
- 2024-12-10
- Substance
- FENOPROFEN CALCIUM
- Active strength
- 300 mg/1
- Pharmacologic classes
- Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], 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
- FENOPRON
- Brand name suffix
- TM
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| FENOPROFEN CALCIUM | 300 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 0X2CW1QABJ |
| Rxcui | 197695, 2699827 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 61825-311-10 | FENOPRONTM | 100 in 1 BOTTLE | CAPSULE | 100 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 61825-311 | FENOPRON TM (FENOPROFEN CALCIUM) CAPSULE [GALT PHARMACEUTICALS, LLC] | 1 | Current NDC, 1 package rows | 20241220_2ed1a69a-2375-4cc8-ac2f-1201d7e0b9d0.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 61825-311-10 | 61825031110 | 100 CAPSULE in 1 BOTTLE (61825-311-10) | 100 capsule | 2024-12-10 | No | No | Current |