Etodolac
- Product NDC
- 80425-0551
- 11-digit product format
- 804250551
- Labeler code
- 80425
- Product ID
- 80425-0551_3d87cc75-7a10-46a2-e063-6294a90a6d49
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Etodolac
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Advanced Rx of Tennessee, LLC
- Application
- ANDA075074
- Marketing category
- ANDA
- Marketing start
- 2025-08-29
- 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
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Etodolac
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ETODOLAC | 400 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 2M36281008 |
| Rxcui | 197686 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 80425-0551-1 | Etodolac | 60 in 1 BOTTLE | TABLET, FILM COATED | 60 | | 1 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 80425-0551-1 | 80425055101 | 60 TABLET, FILM COATED in 1 BOTTLE (80425-0551-1) | 2025-08-29 | No | No | Current |