Etodolac
- Product NDC
- 68788-7315
- 11-digit product format
- 687887315
- Labeler code
- 68788
- Product ID
- 68788-7315_dc20bec2-e885-442a-93bb-2de09faa44c9
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Etodolac
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Preferred Pharmaceuticals Inc.
- Application
- ANDA208834
- Marketing category
- ANDA
- Marketing start
- 2019-01-02
- 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
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Etodolac
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ETODOLAC | 400 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 2M36281008 |
| Rxcui | 197686 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68788-7315-1 | Etodolac | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | | 7 |
| 68788-7315-2 | Etodolac | 20 in 1 BOTTLE | TABLET, FILM COATED | 20 | | 7 |
| 68788-7315-3 | Etodolac | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 7 |
| 68788-7315-6 | Etodolac | 60 in 1 BOTTLE | TABLET, FILM COATED | 60 | | 7 |
| 68788-7315-9 | Etodolac | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | | 7 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68788-7315 | ETODOLAC TABLET, FILM COATED [PREFERRED PHARMACEUTICALS INC.] | 6 | Current NDC, Legacy NDC, 5 package rows | 20250504_55ae2e78-d803-496b-b66d-af1140312785.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 |
|---|
| 68788-7315-1 | 68788731501 | 100 TABLET, FILM COATED in 1 BOTTLE (68788-7315-1) | 2019-01-02 | 0000-00-00 | No | No | Current |
| 68788-7315-2 | 68788731502 | 20 TABLET, FILM COATED in 1 BOTTLE (68788-7315-2) | 2019-01-02 | 0000-00-00 | No | No | Current |
| 68788-7315-3 | 68788731503 | 30 TABLET, FILM COATED in 1 BOTTLE (68788-7315-3) | 2019-01-02 | 0000-00-00 | No | No | Current |
| 68788-7315-6 | 68788731506 | 60 TABLET, FILM COATED in 1 BOTTLE (68788-7315-6) | 2019-01-02 | 0000-00-00 | No | No | Current |
| 68788-7315-9 | 68788731509 | 90 TABLET, FILM COATED in 1 BOTTLE (68788-7315-9) | 2019-01-02 | 0000-00-00 | No | No | Current |