Etodolac
- Product NDC
- 60505-0041
- 11-digit product format
- 605050041
- Labeler code
- 60505
- Product ID
- 60505-0041_2da02bc5-af97-2998-e639-79e3197375b0
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Etodolac
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Apotex Corp.
- Application
- ANDA076004
- Marketing category
- ANDA
- Marketing start
- 2003-05-01
- 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, 199390 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 60505-0041-1 | Etodolac | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | | 16 |
| 60505-0041-2 | Etodolac | 500 in 1 BOTTLE | TABLET, FILM COATED | 500 | | 16 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 60505-0041 | ETODOLAC TABLET, FILM COATED [APOTEX CORP.] | 15 | Current NDC, Legacy NDC, 2 package rows | 20240809_4d682f98-1e8a-4c2b-6df3-169d2ed10dc1.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 |
|---|
| 60505-0041-1 | 60505004101 | 100 TABLET, FILM COATED in 1 BOTTLE (60505-0041-1) | 2003-05-01 | 0000-00-00 | No | No | Current |
| 60505-0041-2 | 60505004102 | 500 TABLET, FILM COATED in 1 BOTTLE (60505-0041-2) | 2003-05-01 | 0000-00-00 | No | No | Current |