Indomethacin
- Product NDC
- 10544-083
- 11-digit product format
- 105440083
- Labeler code
- 10544
- Product ID
- 10544-083_106f49e0-fdf7-4596-a3d3-c3c0ce363b8f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Indomethacin
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Blenheim Pharmacal, Inc.
- Application
- ANDA091276
- Marketing category
- ANDA
- Marketing start
- 2012-08-13
- Marketing end
- 0000-00-00
- Substance
- INDOMETHACIN
- Active strength
- 50 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 |
|---|
| 10544-083-21 | Indomethacin | 21 in 1 BOTTLE | CAPSULE | 21 | | 5 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| INDOMETHACIN | ACTIVE INGREDIENT | XXE1CET956 | INDOMETHACIN CAPSULE [BLENHEIM PHARMACAL, INC.] | 5 | |
| INDOMETHACIN | ACTIVE MOIETY | XXE1CET956 | INDOMETHACIN CAPSULE [BLENHEIM PHARMACAL, INC.] | 5 | |
| ALCOHOL | INACTIVE INGREDIENT | 3K9958V90M | INDOMETHACIN CAPSULE [BLENHEIM PHARMACAL, INC.] | 5 | |
| AMMONIA | INACTIVE INGREDIENT | 5138Q19F1X | INDOMETHACIN CAPSULE [BLENHEIM PHARMACAL, INC.] | 5 | |
| BUTYL ALCOHOL | INACTIVE INGREDIENT | 8PJ61P6TS3 | INDOMETHACIN CAPSULE [BLENHEIM PHARMACAL, INC.] | 5 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | INDOMETHACIN CAPSULE [BLENHEIM PHARMACAL, INC.] | 5 | |
| D&C YELLOW NO. 10 | INACTIVE INGREDIENT | 35SW5USQ3G | INDOMETHACIN CAPSULE [BLENHEIM PHARMACAL, INC.] | 5 | |
| FD&C BLUE NO. 1 | INACTIVE INGREDIENT | H3R47K3TBD | INDOMETHACIN CAPSULE [BLENHEIM PHARMACAL, INC.] | 5 | |
| FERROSOFERRIC OXIDE | INACTIVE INGREDIENT | XM0M87F357 | INDOMETHACIN CAPSULE [BLENHEIM PHARMACAL, INC.] | 5 | |
| GELATIN | INACTIVE INGREDIENT | 2G86QN327L | INDOMETHACIN CAPSULE [BLENHEIM PHARMACAL, INC.] | 5 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | INDOMETHACIN CAPSULE [BLENHEIM PHARMACAL, INC.] | 5 | |
| ISOPROPYL ALCOHOL | INACTIVE INGREDIENT | ND2M416302 | INDOMETHACIN CAPSULE [BLENHEIM PHARMACAL, INC.] | 5 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | INDOMETHACIN CAPSULE [BLENHEIM PHARMACAL, INC.] | 5 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | INDOMETHACIN CAPSULE [BLENHEIM PHARMACAL, INC.] | 5 | |
| POTASSIUM HYDROXIDE | INACTIVE INGREDIENT | WZH3C48M4T | INDOMETHACIN CAPSULE [BLENHEIM PHARMACAL, INC.] | 5 | |
| PROPYLENE GLYCOL | INACTIVE INGREDIENT | 6DC9Q167V3 | INDOMETHACIN CAPSULE [BLENHEIM PHARMACAL, INC.] | 5 | |
| SHELLAC | INACTIVE INGREDIENT | 46N107B71O | INDOMETHACIN CAPSULE [BLENHEIM PHARMACAL, INC.] | 5 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | INDOMETHACIN CAPSULE [BLENHEIM PHARMACAL, INC.] | 5 | |
| SODIUM LAURYL SULFATE | INACTIVE INGREDIENT | 368GB5141J | INDOMETHACIN CAPSULE [BLENHEIM PHARMACAL, INC.] | 5 | |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | INACTIVE INGREDIENT | 5856J3G2A2 | INDOMETHACIN CAPSULE [BLENHEIM PHARMACAL, INC.] | 5 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | INDOMETHACIN CAPSULE [BLENHEIM PHARMACAL, INC.] | 5 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 10544-083 | INDOMETHACIN CAPSULE [BLENHEIM PHARMACAL, INC.] | 5 | Legacy NDC, 1 package rows | 20150731_a9b815a8-5e80-4a54-958c-6c307b87f323.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Status |
|---|
| 10544-083-21 | 10544008321 | 21 in 1 BOTTLE | Historical |