Etodolac
- Product NDC
- 43063-578
- 11-digit product format
- 430630578
- Labeler code
- 43063
- Product ID
- 43063-578_509d79d4-ae97-3e89-e063-6294a90a346d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Etodolac
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- PD-Rx Pharmaceuticals, Inc.
- Application
- ANDA076004
- Marketing category
- ANDA
- Marketing start
- 2003-05-01
- 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 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 43063-578-20 | Etodolac | 20 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 20 | | 17 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| Etodolac | ACTIVE INGREDIENT | 2M36281008 | ETODOLAC TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] | 4 | |
| etodolac | ACTIVE MOIETY | 2M36281008 | ETODOLAC TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] | 4 | |
| CROSPOVIDONE | INACTIVE INGREDIENT | 68401960MK | ETODOLAC TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] | 4 | |
| HYDROXYPROPYL CELLULOSE (TYPE H) | INACTIVE INGREDIENT | RFW2ET671P | ETODOLAC TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] | 4 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | ETODOLAC TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] | 4 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | ETODOLAC TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] | 4 | |
| METHYLCELLULOSE (100 CPS) | INACTIVE INGREDIENT | 4GFU244C4J | ETODOLAC TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] | 4 | |
| POLYETHYLENE GLYCOLS | INACTIVE INGREDIENT | 3WJQ0SDW1A | ETODOLAC TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] | 4 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | ETODOLAC TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] | 4 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 43063-578 | ETODOLAC TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] | 15 | Current NDC, Legacy NDC, 1 package rows | 20240922_556eaa67-d30d-4095-a981-c65f98d3acdd.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 |
|---|
| 43063-578-20 | 43063057820 | 20 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-578-20) | 2009-10-28 | 0000-00-00 | No | No | Current |