Etodolac
- Product NDC
- 80425-0190
- 11-digit product format
- 804250190
- Labeler code
- 80425
- Product ID
- 80425-0190_2a99a7c1-c4c5-2b01-e063-6294a90aa3b8
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Etodolac
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Advanced Rx Pharmacy of Tennessee, LLC
- Application
- ANDA076004
- Marketing category
- ANDA
- Marketing start
- 2022-06-14
- Substance
- ETODOLAC
- Active strength
- 400 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
- 2026-12-31
- Current FDA listing
- Yes
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| 2M36281008 | ETODOLAC | 41340-25-4 | ETODOLAC |
Packages
| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 80425-0190-2 | 80425019002 | 60 TABLET, FILM COATED in 1 BOTTLE (80425-0190-2) | 2024-02-17 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Etodolac Tablet | Advanced Rx Pharmacy of Tennessee, LLC | 2024-12-31 | HUMAN PRESCRIPTION DRUG LABEL | 4 |