Etodolac
- Product NDC
- 43353-753
- 11-digit product format
- 433530753
- Labeler code
- 43353
- Product ID
- 43353-753_fbe19c2c-9e78-41d9-9455-21ed571956e5
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Etodolac
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Aphena Pharma Solutions - Tennessee, LLC
- Application
- ANDA075078
- Marketing category
- ANDA
- Marketing start
- 1998-04-05
- Marketing end
- 0000-00-00
- Substance
- ETODOLAC
- Active strength
- 300 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#
NDC, Effective, Action table| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|
| 43353-753-30 | 2023-01-30 | C162847 | 48780-1 | f386c649-9dbc-0266-e053-dadaa90a7c1a | Etodolac Capsules, Tablets and ER Tablets, USP |
| 43353-753-53 | 2023-01-30 | C162847 | 48780-1 | f386c649-9dbc-0266-e053-dadaa90a7c1a | Etodolac Capsules, Tablets and ER Tablets, USP |
| 43353-753-60 | 2023-01-30 | C162847 | 48780-1 | f386c649-9dbc-0266-e053-dadaa90a7c1a | Etodolac Capsules, Tablets and ER Tablets, USP |
| 43353-753-70 | 2023-01-30 | C162847 | 48780-1 | f386c649-9dbc-0266-e053-dadaa90a7c1a | Etodolac Capsules, Tablets and ER Tablets, USP |
| 43353-753-80 | 2023-01-30 | C162847 | 48780-1 | f386c649-9dbc-0266-e053-dadaa90a7c1a | Etodolac Capsules, Tablets and ER Tablets, USP |
| 43353-753-87 | 2023-01-30 | C162847 | 48780-1 | f386c649-9dbc-0266-e053-dadaa90a7c1a | Etodolac Capsules, Tablets and ER Tablets, USP |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 43353-753-30 | Etodolac | 30 in 1 BOTTLE, PLASTIC | CAPSULE | 30 | | 3 |
| 43353-753-53 | Etodolac | 60 in 1 BOTTLE, PLASTIC | CAPSULE | 60 | | 3 |
| 43353-753-60 | Etodolac | 90 in 1 BOTTLE, PLASTIC | CAPSULE | 90 | | 3 |
| 43353-753-70 | Etodolac | 120 in 1 BOTTLE, PLASTIC | CAPSULE | 120 | | 3 |
| 43353-753-80 | Etodolac | 180 in 1 BOTTLE, PLASTIC | CAPSULE | 180 | | 3 |
| 43353-753-87 | Etodolac | 2400 in 1 BOTTLE, PLASTIC | CAPSULE | 2400 | | 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 |
|---|
| 43353-753 | ETODOLAC CAPSULE ETODOLAC TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 3 | Legacy NDC, 6 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 | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 43353-753-30 | 43353075330 | 30 CAPSULE in 1 BOTTLE, PLASTIC (43353-753-30) | 30 capsule | 2015-02-25 | 0000-00-00 | No | No | Current |
| 43353-753-53 | 43353075353 | 60 CAPSULE in 1 BOTTLE, PLASTIC (43353-753-53) | 60 capsule | 2011-08-11 | 0000-00-00 | No | No | Current |
| 43353-753-60 | 43353075360 | 90 CAPSULE in 1 BOTTLE, PLASTIC (43353-753-60) | 90 capsule | 2011-08-11 | 0000-00-00 | No | No | Current |
| 43353-753-70 | 43353075370 | 120 CAPSULE in 1 BOTTLE, PLASTIC (43353-753-70) | 120 capsule | 2015-02-25 | 0000-00-00 | No | No | Current |
| 43353-753-80 | 43353075380 | 180 CAPSULE in 1 BOTTLE, PLASTIC (43353-753-80) | 180 capsule | 2015-02-25 | 0000-00-00 | No | No | Current |
| 43353-753-87 | 43353075387 | 2400 CAPSULE in 1 BOTTLE, PLASTIC (43353-753-87) | 2400 capsule | 2014-02-11 | 0000-00-00 | No | No | Current |