Etodolac
- Product NDC
- 0185-0675
- 11-digit product format
- 001850675
- Labeler code
- 0185
- Product ID
- 0185-0675_1ad440d5-7e56-4d98-ba75-56eac1fafb01
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Etodolac
- Dosage form
- TABLET, COATED
- Route
- ORAL
- Labeler
- Eon Labs, Inc.
- Application
- ANDA074903
- Marketing category
- ANDA
- Marketing start
- 2015-04-20
- Marketing end
- 0000-00-00
- 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
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| ETODOLAC | ACTIVE INGREDIENT | 2M36281008 | ETODOLAC TABLET, COATED [EON LABS, INC.] | 11 | |
| ETODOLAC | ACTIVE MOIETY | 2M36281008 | ETODOLAC TABLET, COATED [EON LABS, INC.] | 11 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | ETODOLAC TABLET, COATED [EON LABS, INC.] | 11 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | ETODOLAC TABLET, COATED [EON LABS, INC.] | 11 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | ETODOLAC TABLET, COATED [EON LABS, INC.] | 11 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | ETODOLAC TABLET, COATED [EON LABS, INC.] | 11 | |
| POLYETHYLENE GLYCOLS | INACTIVE INGREDIENT | 3WJQ0SDW1A | ETODOLAC TABLET, COATED [EON LABS, INC.] | 11 | |
| POLYSORBATE 80 | INACTIVE INGREDIENT | 6OZP39ZG8H | ETODOLAC TABLET, COATED [EON LABS, INC.] | 11 | |
| POVIDONES | INACTIVE INGREDIENT | FZ989GH94E | ETODOLAC TABLET, COATED [EON LABS, INC.] | 11 | |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | INACTIVE INGREDIENT | 5856J3G2A2 | ETODOLAC TABLET, COATED [EON LABS, INC.] | 11 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | ETODOLAC TABLET, COATED [EON LABS, INC.] | 11 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | ETODOLAC TABLET, COATED [EON LABS, INC.] | 11 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0185-0675 | ETODOLAC TABLET, COATED [EON LABS, INC.] | 20 | Legacy NDC | 20231102_ba37476d-05a4-48cb-9cee-6b10e0dd5bf4.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0185-0675-01 | 00185067501 | 100 TABLET, COATED in 1 BOTTLE (0185-0675-01) | 2015-04-20 | 0000-00-00 | No | No | Current |
| 0185-0675-05 | 00185067505 | 500 TABLET, COATED in 1 BOTTLE (0185-0675-05) | 2015-04-20 | 0000-00-00 | No | No | Current |
| 0185-0675-10 | 00185067510 | 1000 TABLET, COATED in 1 BOTTLE (0185-0675-10) | 2015-04-20 | 0000-00-00 | No | No | Current |