Etodolac
- Product NDC
- 71335-2259
- 11-digit product format
- 713352259
- Labeler code
- 71335
- Product ID
- 71335-2259_2b889026-2eb9-4894-a68d-2fcf5a3ceae4
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Etodolac
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA210704
- Marketing category
- ANDA
- Marketing start
- 2021-08-01
- 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 |
|---|
| ETODOLAC | 400 mg/1 |
Harmonized Identifiers
| Field | Values |
|---|
| Unii | 2M36281008 |
| Rxcui | 197686 |
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| 2M36281008 | ETODOLAC | 41340-25-4 | ETODOLAC |
Packages
| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 71335-2259-1 | 71335225901 | 20 TABLET, FILM COATED in 1 BOTTLE (71335-2259-1) | 2023-10-30 | No | No | Historical |
| 71335-2259-2 | 71335225902 | 14 TABLET, FILM COATED in 1 BOTTLE (71335-2259-2) | 2023-10-30 | No | No | Historical |
| 71335-2259-3 | 71335225903 | 30 TABLET, FILM COATED in 1 BOTTLE (71335-2259-3) | 2023-10-30 | No | No | Historical |
| 71335-2259-4 | 71335225904 | 100 TABLET, FILM COATED in 1 BOTTLE (71335-2259-4) | 2023-10-30 | No | No | Historical |
| 71335-2259-5 | 71335225905 | 60 TABLET, FILM COATED in 1 BOTTLE (71335-2259-5) | 2023-10-30 | No | No | Historical |
| 71335-2259-6 | 71335225906 | 90 TABLET, FILM COATED in 1 BOTTLE (71335-2259-6) | 2023-10-30 | No | No | Historical |
| 71335-2259-7 | 71335225907 | 56 TABLET, FILM COATED in 1 BOTTLE (71335-2259-7) | 2023-10-30 | No | No | Historical |
| 71335-2259-8 | 71335225908 | 120 TABLET, FILM COATED in 1 BOTTLE (71335-2259-8) | 2023-10-30 | No | No | Historical |