etodolac
- Product NDC
- 83980-032
- 11-digit product format
- 839800032
- Labeler code
- 83980
- Product ID
- 83980-032_fa34700b-9acd-4ccf-9e98-0f88e4a35e12
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- etodolac
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Ipca Laboratories Limited
- Application
- ANDA205448
- Marketing category
- ANDA
- Marketing start
- 2026-02-06
- Substance
- ETODOLAC
- Active strength
- 300 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 | 300 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 2M36281008 |
| Rxcui | 197684, 197685 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 83980-032-01 | etodolac | 100 in 1 BOTTLE | CAPSULE | 100 | | 1 |
| 83980-032-05 | etodolac | 500 in 1 BOTTLE | CAPSULE | 500 | | 1 |
| 83980-032-13 | etodolac | 30 in 1 BOTTLE | CAPSULE | 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 |
|---|
| 83980-032-01 | 83980003201 | 100 CAPSULE in 1 BOTTLE (83980-032-01) | 100 capsule | 2026-02-06 | No | No | Current |
| 83980-032-05 | 83980003205 | 500 CAPSULE in 1 BOTTLE (83980-032-05) | 500 capsule | 2026-02-06 | No | No | Current |
| 83980-032-13 | 83980003213 | 30 CAPSULE in 1 BOTTLE (83980-032-13) | 30 capsule | 2026-02-06 | No | No | Current |