Etodolac
- Product NDC
- 63629-8598
- 11-digit product format
- 636298598
- Labeler code
- 63629
- Product ID
- 63629-8598_24f87f5a-05f7-4825-b5d5-344596325f0c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Etodolac
- Dosage form
- TABLET, FILM COATED, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA091134
- Marketing category
- ANDA
- Marketing start
- 2014-02-15
- Substance
- ETODOLAC
- Active strength
- 600 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 | 600 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 2M36281008 |
| Rxcui | 310247 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 63629-8598-1 | Etodolac | 30 in 1 BOTTLE | TABLET, FILM COATED, EXTENDED RE | 30 | | 105 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 63629-8598 | ETODOLAC TABLET, FILM COATED, EXTENDED RELEASE [BRYANT RANCH PREPACK] | 105 | Current NDC, Legacy NDC, 1 package rows | 20241023_1e4824cc-4d52-4f20-9674-cfcb9ee66574.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 |
|---|
| 63629-8598-1 | 63629859801 | 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (63629-8598-1) | 2021-06-22 | 0000-00-00 | No | No | Current |