Etodolac
- Product NDC
- 63187-793
- 11-digit product format
- 631870793
- Labeler code
- 63187
- Product ID
- 63187-793_e29663ca-306c-4e25-a233-fe701cee7071
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Etodolac
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Proficient Rx LP
- Application
- ANDA076174
- Marketing category
- ANDA
- Marketing start
- 2003-03-13
- 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 | 310245 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 63187-793-20 | Etodolac | 20 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 20 | | 3 |
| 63187-793-30 | Etodolac | 30 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 30 | | 3 |
| 63187-793-60 | Etodolac | 60 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 60 | | 3 |
| 63187-793-90 | Etodolac | 90 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 90 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 63187-793 | ETODOLAC TABLET, EXTENDED RELEASE [PROFICIENT RX LP] | 3 | Current NDC, Legacy NDC, 4 package rows | 20191115_449b273a-936a-4c49-b0c8-d0daa47733ae.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 |
|---|
| 63187-793-20 | 63187079320 | 20 TABLET, EXTENDED RELEASE in 1 BOTTLE (63187-793-20) | 2016-12-01 | 0000-00-00 | No | No | Current |
| 63187-793-30 | 63187079330 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (63187-793-30) | 2016-12-01 | 0000-00-00 | No | No | Current |
| 63187-793-60 | 63187079360 | 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (63187-793-60) | 2016-12-01 | 0000-00-00 | No | No | Current |
| 63187-793-90 | 63187079390 | 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (63187-793-90) | 2016-12-01 | 0000-00-00 | No | No | Current |