etodolac
- Product NDC
- 83980-029
- 11-digit product format
- 839800029
- Labeler code
- 83980
- Product ID
- 83980-029_4064e892-4c7a-46a7-9114-3e2bf466e597
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- etodolac
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Ipca Laboratories Limited
- Application
- ANDA204729
- Marketing category
- ANDA
- Marketing start
- 2026-02-13
- 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, 199390 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 83980-029-01 | etodolac | 100 in 1 BOTTLE | TABLET | 100 | | 1 |
| 83980-029-10 | etodolac | 1000 in 1 BOTTLE | TABLET | 1000 | | 1 |
| 83980-029-13 | etodolac | 30 in 1 BOTTLE | TABLET | 30 | | 1 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 83980-029-01 | 83980002901 | 100 TABLET in 1 BOTTLE (83980-029-01) | 100 tablet | 2026-02-13 | No | No | Current |
| 83980-029-10 | 83980002910 | 1000 TABLET in 1 BOTTLE (83980-029-10) | 1000 tablet | 2026-02-13 | No | No | Current |
| 83980-029-13 | 83980002913 | 30 TABLET in 1 BOTTLE (83980-029-13) | 30 tablet | 2026-02-13 | No | No | Current |