Etodolac
- Product NDC
- 65841-778
- 11-digit product format
- 658410778
- Labeler code
- 65841
- Product ID
- 65841-778_12ad7193-e8e8-49cd-871c-e7a4c47f32c4
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Etodolac
- Dosage form
- TABLET, FILM COATED, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Zydus Lifesciences Limited
- Application
- ANDA091134
- Marketing category
- ANDA
- Marketing start
- 2014-02-15
- Substance
- ETODOLAC
- Active strength
- 500 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 | 500 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 2M36281008 |
| Rxcui | 310245, 310247, 359500 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 65841-778-01 | Etodolac | 100 in 1 BOTTLE | TABLET, FILM COATED, EXTENDED RE | 100 | | 8 |
| 65841-778-05 | Etodolac | 500 in 1 BOTTLE | TABLET, FILM COATED, EXTENDED RE | 500 | | 8 |
| 65841-778-10 | Etodolac | 1000 in 1 BOTTLE | TABLET, FILM COATED, EXTENDED RE | 1000 | | 8 |
| 65841-778-14 | Etodolac | 60 in 1 BOTTLE | TABLET, FILM COATED, EXTENDED RE | 60 | | 8 |
| 65841-778-30 | Etodolac | 1 in 1 BLISTER PACK | TABLET, FILM COATED, EXTENDED RE | 1 | | 8 |
| 65841-778-77 | Etodolac | 100 in 1 CARTON | TABLET, FILM COATED, EXTENDED RE | 100 | | 8 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 65841-778 | ETODOLAC TABLET, FILM COATED, EXTENDED RELEASE [ZYDUS LIFESCIENCES LIMITED] | 8 | Current NDC, Legacy NDC, 6 package rows | 20241201_0c5f8631-f013-4bbb-b610-0a8a1311844e.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 65841-778-01 | 65841077801 | 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (65841-778-01) | | 2014-02-15 | 0000-00-00 | No | No | Current |
| 65841-778-05 | 65841077805 | 500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (65841-778-05) | | 2014-02-15 | 0000-00-00 | No | No | Current |
| 65841-778-10 | 65841077810 | 1000 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (65841-778-10) | | 2014-02-15 | 0000-00-00 | No | No | Current |
| 65841-778-14 | 65841077814 | 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (65841-778-14) | | 2014-02-15 | 0000-00-00 | No | No | Current |
| 65841-778-30 | 65841077830 | 1 in 1 BLISTER PACK | | | | | | Historical |
| 65841-778-77 | 65841077877 | 100 BLISTER PACK in 1 CARTON (65841-778-77) / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (65841-778-30) | 100 blister pack | 2014-02-15 | 0000-00-00 | No | No | Current |