Etodolac
- Product NDC
- 68788-8673
- 11-digit product format
- 687888673
- Labeler code
- 68788
- Product ID
- 68788-8673_57f3f31f-ad26-40e2-a5aa-167b4e8bc781
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Etodolac
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Preferred Pharmaceuticals Inc.
- Application
- ANDA075074
- Marketing category
- ANDA
- Marketing start
- 2024-05-22
- 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 |
|---|
| 68788-8673-1 | Etodolac | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | | 3 |
| 68788-8673-2 | Etodolac | 20 in 1 BOTTLE | TABLET, FILM COATED | 20 | | 3 |
| 68788-8673-3 | Etodolac | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 3 |
| 68788-8673-6 | Etodolac | 60 in 1 BOTTLE | TABLET, FILM COATED | 60 | | 3 |
| 68788-8673-9 | Etodolac | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68788-8673 | ETODOLAC TABLET, FILM COATED [PREFERRED PHARMACEUTICALS INC.] | 2 | Current NDC, 5 package rows | 20250507_117b3005-a8ec-4f76-824c-95ec42dc87a1.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 68788-8673-1 | 68788867301 | 100 TABLET, FILM COATED in 1 BOTTLE (68788-8673-1) | 2024-05-22 | No | No | Historical |
| 68788-8673-2 | 68788867302 | 20 TABLET, FILM COATED in 1 BOTTLE (68788-8673-2) | 2024-05-22 | No | No | Historical |
| 68788-8673-3 | 68788867303 | 30 TABLET, FILM COATED in 1 BOTTLE (68788-8673-3) | 2024-05-22 | No | No | Historical |
| 68788-8673-6 | 68788867306 | 60 TABLET, FILM COATED in 1 BOTTLE (68788-8673-6) | 2024-05-22 | No | No | Historical |
| 68788-8673-9 | 68788867309 | 90 TABLET, FILM COATED in 1 BOTTLE (68788-8673-9) | 2024-05-22 | No | No | Historical |