Etodolac
- Product NDC
- 68071-3731
- 11-digit product format
- 680713731
- Labeler code
- 68071
- Product ID
- 68071-3731_2a09976c-6054-3e36-e063-6394a90a3e6e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Etodolac
- Dosage form
- TABLET, FILM COATED, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- NuCare Pharmaceuticals, Inc.
- Application
- ANDA091134
- Marketing category
- ANDA
- Marketing start
- 2014-02-15
- 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 table| Ingredient | Strength |
|---|
| ETODOLAC | 400 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 2M36281008 |
| Rxcui | 310245 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68071-3731-4 | Etodolac | 14 in 1 BOTTLE | TABLET, FILM COATED, EXTENDED RE | 14 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68071-3731 | ETODOLAC TABLET, FILM COATED, EXTENDED RELEASE [NUCARE PHARMACEUTICALS, INC.] | 2 | Current NDC, 1 package rows | 20241226_27e98e6d-9fad-3a94-e063-6394a90a1dcb.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 68071-3731-4 | 68071373104 | 14 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68071-3731-4) | 2024-11-27 | No | No | Historical |