Etodolac
- Product NDC
- 62559-251
- 11-digit product format
- 625590251
- Labeler code
- 62559
- Product ID
- 62559-251_b45612f5-5724-43e1-a1e4-c9f9c0ce5c5b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Etodolac
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- ANI Pharmaceuticals, Inc.
- Application
- ANDA075126
- Marketing category
- ANDA
- Marketing start
- 2015-02-01
- 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
- 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 | 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 |
|---|
| 62559-251-01 | Etodolac | 100 in 1 BOTTLE | CAPSULE | 100 | | 11 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| ETODOLAC | ACTIVE INGREDIENT | 2M36281008 | ETODOLAC CAPSULE [ANI PHARMACEUTICALS, INC.] | 3 | |
| ETODOLAC | ACTIVE MOIETY | 2M36281008 | ETODOLAC CAPSULE [ANI PHARMACEUTICALS, INC.] | 3 | |
| D&C RED NO. 28 | INACTIVE INGREDIENT | 767IP0Y5NH | ETODOLAC CAPSULE [ANI PHARMACEUTICALS, INC.] | 3 | |
| D&C RED NO. 33 | INACTIVE INGREDIENT | 9DBA0SBB0L | ETODOLAC CAPSULE [ANI PHARMACEUTICALS, INC.] | 3 | |
| D&C YELLOW NO. 10 | INACTIVE INGREDIENT | 35SW5USQ3G | ETODOLAC CAPSULE [ANI PHARMACEUTICALS, INC.] | 3 | |
| FD&C BLUE NO. 1 | INACTIVE INGREDIENT | H3R47K3TBD | ETODOLAC CAPSULE [ANI PHARMACEUTICALS, INC.] | 3 | |
| FD&C RED NO. 40 | INACTIVE INGREDIENT | WZB9127XOA | ETODOLAC CAPSULE [ANI PHARMACEUTICALS, INC.] | 3 | |
| FERROSOFERRIC OXIDE | INACTIVE INGREDIENT | XM0M87F357 | ETODOLAC CAPSULE [ANI PHARMACEUTICALS, INC.] | 3 | |
| GELATIN | INACTIVE INGREDIENT | 2G86QN327L | ETODOLAC CAPSULE [ANI PHARMACEUTICALS, INC.] | 3 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | ETODOLAC CAPSULE [ANI PHARMACEUTICALS, INC.] | 3 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | ETODOLAC CAPSULE [ANI PHARMACEUTICALS, INC.] | 3 | |
| POVIDONE K25 | INACTIVE INGREDIENT | K0KQV10C35 | ETODOLAC CAPSULE [ANI PHARMACEUTICALS, INC.] | 3 | |
| PROPYLENE GLYCOL | INACTIVE INGREDIENT | 6DC9Q167V3 | ETODOLAC CAPSULE [ANI PHARMACEUTICALS, INC.] | 3 | |
| SHELLAC | INACTIVE INGREDIENT | 46N107B71O | ETODOLAC CAPSULE [ANI PHARMACEUTICALS, INC.] | 3 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | ETODOLAC CAPSULE [ANI PHARMACEUTICALS, INC.] | 3 | |
| SODIUM LAURYL SULFATE | INACTIVE INGREDIENT | 368GB5141J | ETODOLAC CAPSULE [ANI PHARMACEUTICALS, INC.] | 3 | |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | INACTIVE INGREDIENT | 5856J3G2A2 | ETODOLAC CAPSULE [ANI PHARMACEUTICALS, INC.] | 3 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | ETODOLAC CAPSULE [ANI PHARMACEUTICALS, INC.] | 3 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | ETODOLAC CAPSULE [ANI PHARMACEUTICALS, INC.] | 3 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 62559-251 | ETODOLAC CAPSULE [ANI PHARMACEUTICALS, INC.] | 10 | Current NDC, Legacy NDC, 1 package rows | 20240805_420c7b62-3bea-4d6b-82e0-ab1c176c7f1e.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 62559-251-01 | 62559025101 | 100 CAPSULE in 1 BOTTLE (62559-251-01) | 100 capsule | 2015-02-01 | 0000-00-00 | No | No | Current |