Etodolac
- Product NDC
- 68382-271
- 11-digit product format
- 683820271
- Labeler code
- 68382
- Product ID
- 68382-271_8ceb01d9-ccec-4c22-b56b-563af9da274f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Etodolac
- Dosage form
- TABLET, FILM COATED, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Zydus Pharmaceuticals USA Inc.
- Application
- ANDA091134
- Marketing category
- ANDA
- Marketing start
- 2014-02-15
- 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
- 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 | 400 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 |
|---|
| 68382-271-01 | Etodolac | 100 in 1 BOTTLE | TABLET, FILM COATED, EXTENDED RE | 100 | | 14 |
| 68382-271-05 | Etodolac | 500 in 1 BOTTLE | TABLET, FILM COATED, EXTENDED RE | 500 | | 14 |
| 68382-271-10 | Etodolac | 1000 in 1 BOTTLE | TABLET, FILM COATED, EXTENDED RE | 1000 | | 14 |
| 68382-271-14 | Etodolac | 60 in 1 BOTTLE | TABLET, FILM COATED, EXTENDED RE | 60 | | 14 |
| 68382-271-30 | Etodolac | 1 in 1 BLISTER PACK | TABLET, FILM COATED, EXTENDED RE | 1 | | 14 |
| 68382-271-77 | Etodolac | 100 in 1 CARTON | 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 [ZYDUS PHARMACEUTICALS (USA) INC.] | 2 | |
| ETODOLAC | ACTIVE MOIETY | 2M36281008 | ETODOLAC TABLET, FILM COATED, EXTENDED RELEASE [ZYDUS PHARMACEUTICALS (USA) INC.] | 2 | |
| D&C YELLOW NO. 10 | INACTIVE INGREDIENT | 35SW5USQ3G | ETODOLAC TABLET, FILM COATED, EXTENDED RELEASE [ZYDUS PHARMACEUTICALS (USA) INC.] | 2 | |
| ETHYLCELLULOSE (100 MPA.S) | INACTIVE INGREDIENT | 47MLB0F1MV | ETODOLAC TABLET, FILM COATED, EXTENDED RELEASE [ZYDUS PHARMACEUTICALS (USA) INC.] | 2 | |
| FD&C BLUE NO. 2 | INACTIVE INGREDIENT | L06K8R7DQK | ETODOLAC TABLET, FILM COATED, EXTENDED RELEASE [ZYDUS PHARMACEUTICALS (USA) INC.] | 2 | |
| FD&C RED NO. 40 | INACTIVE INGREDIENT | WZB9127XOA | ETODOLAC TABLET, FILM COATED, EXTENDED RELEASE [ZYDUS PHARMACEUTICALS (USA) INC.] | 2 | |
| FD&C YELLOW NO. 6 | INACTIVE INGREDIENT | H77VEI93A8 | ETODOLAC TABLET, FILM COATED, EXTENDED RELEASE [ZYDUS PHARMACEUTICALS (USA) INC.] | 2 | |
| FERRIC OXIDE RED | INACTIVE INGREDIENT | 1K09F3G675 | ETODOLAC TABLET, FILM COATED, EXTENDED RELEASE [ZYDUS PHARMACEUTICALS (USA) INC.] | 2 | |
| FERRIC OXIDE YELLOW | INACTIVE INGREDIENT | EX438O2MRT | ETODOLAC TABLET, FILM COATED, EXTENDED RELEASE [ZYDUS PHARMACEUTICALS (USA) INC.] | 2 | |
| FERROSOFERRIC OXIDE | INACTIVE INGREDIENT | XM0M87F357 | ETODOLAC TABLET, FILM COATED, EXTENDED RELEASE [ZYDUS PHARMACEUTICALS (USA) INC.] | 2 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | ETODOLAC TABLET, FILM COATED, EXTENDED RELEASE [ZYDUS PHARMACEUTICALS (USA) INC.] | 2 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | ETODOLAC TABLET, FILM COATED, EXTENDED RELEASE [ZYDUS PHARMACEUTICALS (USA) INC.] | 2 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | ETODOLAC TABLET, FILM COATED, EXTENDED RELEASE [ZYDUS PHARMACEUTICALS (USA) INC.] | 2 | |
| POLYETHYLENE GLYCOLS | INACTIVE INGREDIENT | 3WJQ0SDW1A | ETODOLAC TABLET, FILM COATED, EXTENDED RELEASE [ZYDUS PHARMACEUTICALS (USA) INC.] | 2 | |
| SODIUM PHOSPHATE, DIBASIC ANHYDROUS | INACTIVE INGREDIENT | 22ADO53M6F | ETODOLAC TABLET, FILM COATED, EXTENDED RELEASE [ZYDUS PHARMACEUTICALS (USA) INC.] | 2 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | ETODOLAC TABLET, FILM COATED, EXTENDED RELEASE [ZYDUS PHARMACEUTICALS (USA) INC.] | 2 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | ETODOLAC TABLET, FILM COATED, EXTENDED RELEASE [ZYDUS PHARMACEUTICALS (USA) INC.] | 2 | |
| TRIACETIN | INACTIVE INGREDIENT | XHX3C3X673 | ETODOLAC TABLET, FILM COATED, EXTENDED RELEASE [ZYDUS PHARMACEUTICALS (USA) INC.] | 2 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68382-271 | ETODOLAC TABLET, FILM COATED, EXTENDED RELEASE [ZYDUS PHARMACEUTICALS USA INC.] | 14 | Current NDC, Legacy NDC, 6 package rows | 20240921_7ef79e43-0628-4795-937e-ebb752d79133.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 |
|---|
| 68382-271-01 | 68382027101 | 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68382-271-01) | | 2014-02-15 | 0000-00-00 | No | No | Current |
| 68382-271-05 | 68382027105 | 500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68382-271-05) | | 2014-02-15 | 0000-00-00 | No | No | Current |
| 68382-271-10 | 68382027110 | 1000 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68382-271-10) | | 2014-02-15 | 0000-00-00 | No | No | Current |
| 68382-271-14 | 68382027114 | 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68382-271-14) | | 2014-02-15 | 0000-00-00 | No | No | Current |
| 68382-271-30 | 68382027130 | 1 in 1 BLISTER PACK | | | | | | Historical |
| 68382-271-77 | 68382027177 | 100 BLISTER PACK in 1 CARTON (68382-271-77) / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (68382-271-30) | 100 blister pack | 2014-02-15 | 0000-00-00 | No | No | Current |