Etodolac
- Product NDC
- 42799-112
- 11-digit product format
- 427990112
- Labeler code
- 42799
- Product ID
- 42799-112_462de1d4-dc95-527d-e063-6394a90ad55a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Etodolac
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Edenbridge Pharmaceuticals LLC.
- Application
- ANDA209888
- Marketing category
- ANDA
- Marketing start
- 2018-12-07
- 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 | 197686, 199390 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 42799-112-01 | Etodolac | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | | 11 |
| 42799-112-02 | Etodolac | 500 in 1 BOTTLE | TABLET, FILM COATED | 500 | | 11 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 42799-112 | ETODOLAC TABLET, FILM COATED [EDENBRIDGE PHARMACEUTICALS LLC.] | 9 | Current NDC, Legacy NDC, 2 package rows | 20250123_bf1afcd5-e1da-4874-981f-f252cb0b32c2.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 |
|---|
| 42799-112-01 | 42799011201 | 100 TABLET, FILM COATED in 1 BOTTLE (42799-112-01) | 2018-12-07 | 0000-00-00 | No | No | Current |
| 42799-112-02 | 42799011202 | 500 TABLET, FILM COATED in 1 BOTTLE (42799-112-02) | 2018-12-07 | 0000-00-00 | No | No | Current |