Etodolac
- Product NDC
- 43353-749
- 11-digit product format
- 433530749
- Labeler code
- 43353
- Product ID
- 43353-749_fbe19c2c-9e78-41d9-9455-21ed571956e5
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Etodolac
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Aphena Pharma Solutions - Tennessee, LLC
- Application
- ANDA075074
- Marketing category
- ANDA
- Marketing start
- 1998-03-12
- Marketing end
- 0000-00-00
- Substance
- ETODOLAC
- Active strength
- 500 mg/1
- Pharmacologic classes
- Cyclooxygenase Inhibitors [MoA],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2020-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 43353-749-53 | Etodolac | 60 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 60 | | 3 |
| 43353-749-56 | Etodolac | 3000 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 3000 | | 3 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| Etodolac | ACTIVE INGREDIENT | 2M36281008 | ETODOLAC CAPSULE ETODOLAC TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 1 | |
| Etodolac | ACTIVE MOIETY | 2M36281008 | ETODOLAC CAPSULE ETODOLAC TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 1 | |
| ALCOHOL | INACTIVE INGREDIENT | 3K9958V90M | ETODOLAC CAPSULE ETODOLAC TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 1 | |
| AMMONIA | INACTIVE INGREDIENT | 5138Q19F1X | ETODOLAC CAPSULE ETODOLAC TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 1 | |
| BUTYL ALCOHOL | INACTIVE INGREDIENT | 8PJ61P6TS3 | ETODOLAC CAPSULE ETODOLAC TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | ETODOLAC CAPSULE ETODOLAC TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 1 | |
| D&C YELLOW NO. 10 | INACTIVE INGREDIENT | 35SW5USQ3G | ETODOLAC CAPSULE ETODOLAC TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 1 | |
| FD&C BLUE NO. 1 | INACTIVE INGREDIENT | H3R47K3TBD | ETODOLAC CAPSULE ETODOLAC TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 1 | |
| FD&C RED NO. 3 | INACTIVE INGREDIENT | PN2ZH5LOQY | ETODOLAC CAPSULE ETODOLAC TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 1 | |
| FD&C RED NO. 40 | INACTIVE INGREDIENT | WZB9127XOA | ETODOLAC CAPSULE ETODOLAC TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 1 | |
| FERRIC OXIDE RED | INACTIVE INGREDIENT | 1K09F3G675 | ETODOLAC CAPSULE ETODOLAC TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 1 | |
| FERRIC OXIDE YELLOW | INACTIVE INGREDIENT | EX438O2MRT | ETODOLAC CAPSULE ETODOLAC TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 1 | |
| FERROSOFERRIC OXIDE | INACTIVE INGREDIENT | XM0M87F357 | ETODOLAC CAPSULE ETODOLAC TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 1 | |
| Gelatin | INACTIVE INGREDIENT | 2G86QN327L | ETODOLAC CAPSULE ETODOLAC TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 1 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | ETODOLAC CAPSULE ETODOLAC TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 1 | |
| Isopropyl Alcohol | INACTIVE INGREDIENT | ND2M416302 | ETODOLAC CAPSULE ETODOLAC TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 1 | |
| Lactose Monohydrate | INACTIVE INGREDIENT | EWQ57Q8I5X | ETODOLAC CAPSULE ETODOLAC TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 1 | |
| Magnesium Stearate | INACTIVE INGREDIENT | 70097M6I30 | ETODOLAC CAPSULE ETODOLAC TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 1 | |
| POLYETHYLENE GLYCOL 400 | INACTIVE INGREDIENT | B697894SGQ | ETODOLAC CAPSULE ETODOLAC TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 1 | |
| POLYSORBATE 80 | INACTIVE INGREDIENT | 6OZP39ZG8H | ETODOLAC CAPSULE ETODOLAC TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 1 | |
| Povidone | INACTIVE INGREDIENT | FZ989GH94E | ETODOLAC CAPSULE ETODOLAC TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 1 | |
| Propylene Glycol | INACTIVE INGREDIENT | 6DC9Q167V3 | ETODOLAC CAPSULE ETODOLAC TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 1 | |
| SHELLAC | INACTIVE INGREDIENT | 46N107B71O | ETODOLAC CAPSULE ETODOLAC TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 1 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | ETODOLAC CAPSULE ETODOLAC TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 1 | |
| SODIUM STARCH GLYCOLATE TYPE B POTATO | INACTIVE INGREDIENT | 27NA468985 | ETODOLAC CAPSULE ETODOLAC TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 1 | |
| Titanium Dioxide | INACTIVE INGREDIENT | 15FIX9V2JP | ETODOLAC CAPSULE ETODOLAC TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 1 | |
| Water | INACTIVE INGREDIENT | 059QF0KO0R | ETODOLAC CAPSULE ETODOLAC TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 43353-749 | ETODOLAC CAPSULE ETODOLAC TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 3 | Legacy NDC, 2 package rows | 20191228_c9f3dc18-d81c-4b02-8ff4-240c247bcbdd.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 |
|---|
| 43353-749-53 | 43353074953 | 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43353-749-53) | 2011-08-08 | 0000-00-00 | No | No | Current |
| 43353-749-56 | 43353074956 | 3000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43353-749-56) | 2014-04-02 | 0000-00-00 | No | No | Current |