Orudis
- Product NDC
- 28595-031
- 11-digit product format
- 285950031
- Labeler code
- 28595
- Product ID
- 28595-031_47d0b2fe-e786-c7a7-e063-6394a90a3b3a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ketoprofen
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Allegis Pharmaceuticals, Inc.
- Application
- ANDA074014
- Marketing category
- ANDA
- Marketing start
- 2026-01-07
- Substance
- KETOPROFEN
- Active strength
- 75 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
- Orudis
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| KETOPROFEN | 75 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 90Y4QC304K |
| Rxcui | 197856, 206992 |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 28595-031-60 | Orudis | 60 in 1 BOTTLE | CAPSULE | 60 | | 1 |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 28595-031-60 | 28595003160 | 60 CAPSULE in 1 BOTTLE (28595-031-60) | 60 capsule | 2026-01-07 | No | No | Current |