Etodolac
- Product NDC
- 80425-0181
- 11-digit product format
- 804250181
- Labeler code
- 80425
- Product ID
- 80425-0181_2a99a670-af34-299d-e063-6294a90a05d2
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Etodolac
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Advanced Rx Pharmacy of Tennessee, LLC
- Application
- ANDA076174
- Marketing category
- ANDA
- Marketing start
- 2003-03-13
- Substance
- ETODOLAC
- Active strength
- 600 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
- Brand name suffix
- ER
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ETODOLAC | 600 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 2M36281008 |
| Rxcui | 310247 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 80425-0181-1 | EtodolacER | 30 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 30 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 80425-0181 | ETODOLAC ER (ETODOLAC) TABLET, EXTENDED RELEASE [ADVANCED RX PHARMACY OF TENNESSEE, LLC] | 4 | Current NDC, Legacy NDC, 1 package rows | 20250101_d294d541-3049-6bfe-e053-2995a90a23ea.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 80425-0181-1 | 80425018101 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (80425-0181-1) | 2003-03-13 | 0000-00-00 | No | No | Current |