Etodolac
- Product NDC
- 10544-862
- 11-digit product format
- 105440862
- Labeler code
- 10544
- Product ID
- 10544-862_7382e434-9524-4a1d-b70f-86df3421daf6
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Etodolac
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Blenheim Pharmacal, Inc.
- Application
- ANDA075074
- Marketing category
- ANDA
- Marketing start
- 2013-10-08
- Marketing end
- 0000-00-00
- Substance
- ETODOLAC
- Active strength
- 400 mg/1
- Pharmacologic classes
- Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]
- NDC exclude flag
- E
- Listing certified through
- 2017-12-31
- 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 |
|---|
| 10544-862-30 | Etodolac | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 1 |
| 10544-862-60 | Etodolac | 60 in 1 BOTTLE | TABLET, FILM COATED | 60 | | 1 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| Etodolac | ACTIVE INGREDIENT | 2M36281008 | ETODOLAC TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.] | 1 | |
| Etodolac | ACTIVE MOIETY | 2M36281008 | ETODOLAC TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.] | 1 | |
| Cellulose, Microcrystalline | INACTIVE INGREDIENT | OP1R32D61U | ETODOLAC TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.] | 1 | |
| Ferric Oxide Red | INACTIVE INGREDIENT | 1K09F3G675 | ETODOLAC TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.] | 1 | |
| Ferric Oxide Yellow | INACTIVE INGREDIENT | EX438O2MRT | ETODOLAC TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.] | 1 | |
| Hypromelloses | INACTIVE INGREDIENT | 3NXW29V3WO | ETODOLAC TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.] | 1 | |
| Lactose Monohydrate | INACTIVE INGREDIENT | EWQ57Q8I5X | ETODOLAC TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.] | 1 | |
| Magnesium Stearate | INACTIVE INGREDIENT | 70097M6I30 | ETODOLAC TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.] | 1 | |
| Polyethylene Glycols | INACTIVE INGREDIENT | 3WJQ0SDW1A | ETODOLAC TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.] | 1 | |
| POVIDONES | INACTIVE INGREDIENT | FZ989GH94E | ETODOLAC TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.] | 1 | |
| Sodium Starch Glycolate Type A Potato | INACTIVE INGREDIENT | 5856J3G2A2 | ETODOLAC TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.] | 1 | |
| Titanium Dioxide | INACTIVE INGREDIENT | 15FIX9V2JP | ETODOLAC TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 10544-862 | ETODOLAC TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.] | 1 | Legacy NDC, 2 package rows | 20140327_7382e434-9524-4a1d-b70f-86df3421daf6.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Status |
|---|
| 10544-862-30 | 10544086230 | 30 in 1 BOTTLE | Historical |
| 10544-862-60 | 10544086260 | 60 in 1 BOTTLE | Historical |