Etodolac
- Product NDC
- 0093-1118
- 11-digit product format
- 000931118
- Labeler code
- 0093
- Product ID
- 0093-1118_05075c98-6f18-44d0-84d4-28d169638e85
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Etodolac
- Dosage form
- TABLET, FILM COATED, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Teva Pharmaceuticals USA, Inc.
- Application
- ANDA075665
- Marketing category
- ANDA
- Marketing start
- 2000-08-17
- Substance
- ETODOLAC
- Active strength
- 600 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 | 600 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 2M36281008 |
| Rxcui | 310245, 310247, 359500 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0093-1118-01 | Etodolac | 100 in 1 BOTTLE | TABLET, FILM COATED, EXTENDED RE | 100 | | 14 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| ETODOLAC | ACTIVE INGREDIENT | 2M36281008 | ETODOLAC TABLET, FILM COATED, EXTENDED RELEASE [TEVA PHARMACEUTICALS USA INC] | 6 | |
| ETODOLAC | ACTIVE MOIETY | 2M36281008 | ETODOLAC TABLET, FILM COATED, EXTENDED RELEASE [TEVA PHARMACEUTICALS USA INC] | 6 | |
| ALUMINUM OXIDE | INACTIVE INGREDIENT | LMI26O6933 | ETODOLAC TABLET, FILM COATED, EXTENDED RELEASE [TEVA PHARMACEUTICALS USA INC] | 6 | |
| CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS | INACTIVE INGREDIENT | L11K75P92J | ETODOLAC TABLET, FILM COATED, EXTENDED RELEASE [TEVA PHARMACEUTICALS USA INC] | 6 | |
| CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED) | INACTIVE INGREDIENT | Z135WT9208 | ETODOLAC TABLET, FILM COATED, EXTENDED RELEASE [TEVA PHARMACEUTICALS USA INC] | 6 | |
| D&C YELLOW NO. 10 | INACTIVE INGREDIENT | 35SW5USQ3G | ETODOLAC TABLET, FILM COATED, EXTENDED RELEASE [TEVA PHARMACEUTICALS USA INC] | 6 | |
| FD&C BLUE NO. 2 | INACTIVE INGREDIENT | L06K8R7DQK | ETODOLAC TABLET, FILM COATED, EXTENDED RELEASE [TEVA PHARMACEUTICALS USA INC] | 6 | |
| FD&C RED NO. 40 | INACTIVE INGREDIENT | WZB9127XOA | ETODOLAC TABLET, FILM COATED, EXTENDED RELEASE [TEVA PHARMACEUTICALS USA INC] | 6 | |
| FD&C YELLOW NO. 6 | INACTIVE INGREDIENT | H77VEI93A8 | ETODOLAC TABLET, FILM COATED, EXTENDED RELEASE [TEVA PHARMACEUTICALS USA INC] | 6 | |
| FERRIC OXIDE YELLOW | INACTIVE INGREDIENT | EX438O2MRT | ETODOLAC TABLET, FILM COATED, EXTENDED RELEASE [TEVA PHARMACEUTICALS USA INC] | 6 | |
| FERROSOFERRIC OXIDE | INACTIVE INGREDIENT | XM0M87F357 | ETODOLAC TABLET, FILM COATED, EXTENDED RELEASE [TEVA PHARMACEUTICALS USA INC] | 6 | |
| HYDROXYPROPYL CELLULOSE (TYPE H) | INACTIVE INGREDIENT | RFW2ET671P | ETODOLAC TABLET, FILM COATED, EXTENDED RELEASE [TEVA PHARMACEUTICALS USA INC] | 6 | |
| HYPROMELLOSE 2208 (15000 MPA.S) | INACTIVE INGREDIENT | Z78RG6M2N2 | ETODOLAC TABLET, FILM COATED, EXTENDED RELEASE [TEVA PHARMACEUTICALS USA INC] | 6 | |
| HYPROMELLOSE 2910 (15 MPA.S) | INACTIVE INGREDIENT | 36SFW2JZ0W | ETODOLAC TABLET, FILM COATED, EXTENDED RELEASE [TEVA PHARMACEUTICALS USA INC] | 6 | |
| HYPROMELLOSE 2910 (5 MPA.S) | INACTIVE INGREDIENT | R75537T0T4 | ETODOLAC TABLET, FILM COATED, EXTENDED RELEASE [TEVA PHARMACEUTICALS USA INC] | 6 | |
| INDIGOTINDISULFONATE SODIUM | INACTIVE INGREDIENT | D3741U8K7L | ETODOLAC TABLET, FILM COATED, EXTENDED RELEASE [TEVA PHARMACEUTICALS USA INC] | 6 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | ETODOLAC TABLET, FILM COATED, EXTENDED RELEASE [TEVA PHARMACEUTICALS USA INC] | 6 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | ETODOLAC TABLET, FILM COATED, EXTENDED RELEASE [TEVA PHARMACEUTICALS USA INC] | 6 | |
| POLYETHYLENE GLYCOL 4000 | INACTIVE INGREDIENT | 4R4HFI6D95 | ETODOLAC TABLET, FILM COATED, EXTENDED RELEASE [TEVA PHARMACEUTICALS USA INC] | 6 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | ETODOLAC TABLET, FILM COATED, EXTENDED RELEASE [TEVA PHARMACEUTICALS USA INC] | 6 | |
| SODIUM LAURYL SULFATE | INACTIVE INGREDIENT | 368GB5141J | ETODOLAC TABLET, FILM COATED, EXTENDED RELEASE [TEVA PHARMACEUTICALS USA INC] | 6 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | ETODOLAC TABLET, FILM COATED, EXTENDED RELEASE [TEVA PHARMACEUTICALS USA INC] | 6 | |
| ETODOLAC | ACTIVE INGREDIENT | 2M36281008 | ETODOLAC TABLET, FILM COATED, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.] | 3 | |
| ETODOLAC | ACTIVE MOIETY | 2M36281008 | ETODOLAC TABLET, FILM COATED, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.] | 3 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0093-1118 | ETODOLAC TABLET, FILM COATED, EXTENDED RELEASE [TEVA PHARMACEUTICALS USA, INC.] | 13 | Current NDC, Legacy NDC, 1 package rows | 20241219_f3bf1675-8fda-40d3-8427-0a6a6133a3d3.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 |
|---|
| 0093-1118-01 | 00093111801 | 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0093-1118-01) | 2000-08-17 | 0000-00-00 | No | No | Current |