Indomethacin
- Product NDC
- 10544-919
- 11-digit product format
- 105440919
- Labeler code
- 10544
- Product ID
- 10544-919_17c9214f-0ebb-0088-e054-00144ff88e88
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Indomethacin
- Dosage form
- CAPSULE, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Blenheim Pharmacal, Inc.
- Application
- ANDA091549
- Marketing category
- ANDA
- Marketing start
- 2015-06-01
- Marketing end
- 0000-00-00
- Substance
- INDOMETHACIN
- Active strength
- 75 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 |
|---|
| 10544-919-14 | Indomethacin | 30 in 1 BOTTLE | CAPSULE, EXTENDED RELEASE | 30 | | 5 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| INDOMETHACIN | ACTIVE INGREDIENT | XXE1CET956 | INDOMETHACIN CAPSULE, EXTENDED RELEASE [BLENHEIM PHARMACAL, INC.] | 5 | |
| INDOMETHACIN | ACTIVE MOIETY | XXE1CET956 | INDOMETHACIN CAPSULE, EXTENDED RELEASE [BLENHEIM PHARMACAL, INC.] | 5 | |
| ALCOHOL | INACTIVE INGREDIENT | 3K9958V90M | INDOMETHACIN CAPSULE, EXTENDED RELEASE [BLENHEIM PHARMACAL, INC.] | 5 | |
| AMMONIA | INACTIVE INGREDIENT | 5138Q19F1X | INDOMETHACIN CAPSULE, EXTENDED RELEASE [BLENHEIM PHARMACAL, INC.] | 5 | |
| BUTYL ALCOHOL | INACTIVE INGREDIENT | 8PJ61P6TS3 | INDOMETHACIN CAPSULE, EXTENDED RELEASE [BLENHEIM PHARMACAL, INC.] | 5 | |
| FD&C BLUE NO. 1 | INACTIVE INGREDIENT | H3R47K3TBD | INDOMETHACIN CAPSULE, EXTENDED RELEASE [BLENHEIM PHARMACAL, INC.] | 5 | |
| FD&C GREEN NO. 3 | INACTIVE INGREDIENT | 3P3ONR6O1S | INDOMETHACIN CAPSULE, EXTENDED RELEASE [BLENHEIM PHARMACAL, INC.] | 5 | |
| FD&C RED NO. 40 | INACTIVE INGREDIENT | WZB9127XOA | INDOMETHACIN CAPSULE, EXTENDED RELEASE [BLENHEIM PHARMACAL, INC.] | 5 | |
| FD&C YELLOW NO. 5 | INACTIVE INGREDIENT | I753WB2F1M | INDOMETHACIN CAPSULE, EXTENDED RELEASE [BLENHEIM PHARMACAL, INC.] | 5 | |
| FERROSOFERRIC OXIDE | INACTIVE INGREDIENT | XM0M87F357 | INDOMETHACIN CAPSULE, EXTENDED RELEASE [BLENHEIM PHARMACAL, INC.] | 5 | |
| GELATIN | INACTIVE INGREDIENT | 2G86QN327L | INDOMETHACIN CAPSULE, EXTENDED RELEASE [BLENHEIM PHARMACAL, INC.] | 5 | |
| ISOPROPYL ALCOHOL | INACTIVE INGREDIENT | ND2M416302 | INDOMETHACIN CAPSULE, EXTENDED RELEASE [BLENHEIM PHARMACAL, INC.] | 5 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | INDOMETHACIN CAPSULE, EXTENDED RELEASE [BLENHEIM PHARMACAL, INC.] | 5 | |
| POTASSIUM HYDROXIDE | INACTIVE INGREDIENT | WZH3C48M4T | INDOMETHACIN CAPSULE, EXTENDED RELEASE [BLENHEIM PHARMACAL, INC.] | 5 | |
| POVIDONE | INACTIVE INGREDIENT | FZ989GH94E | INDOMETHACIN CAPSULE, EXTENDED RELEASE [BLENHEIM PHARMACAL, INC.] | 5 | |
| PROPYLENE GLYCOL | INACTIVE INGREDIENT | 6DC9Q167V3 | INDOMETHACIN CAPSULE, EXTENDED RELEASE [BLENHEIM PHARMACAL, INC.] | 5 | |
| SHELLAC | INACTIVE INGREDIENT | 46N107B71O | INDOMETHACIN CAPSULE, EXTENDED RELEASE [BLENHEIM PHARMACAL, INC.] | 5 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | INDOMETHACIN CAPSULE, EXTENDED RELEASE [BLENHEIM PHARMACAL, INC.] | 5 | |
| SUCROSE | INACTIVE INGREDIENT | C151H8M554 | INDOMETHACIN CAPSULE, EXTENDED RELEASE [BLENHEIM PHARMACAL, INC.] | 5 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | INDOMETHACIN CAPSULE, EXTENDED RELEASE [BLENHEIM PHARMACAL, INC.] | 5 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 10544-919 | INDOMETHACIN CAPSULE, EXTENDED RELEASE [BLENHEIM PHARMACAL, INC.] | 5 | Legacy NDC, 1 package rows | 20150605_17c9214f-0eba-0088-e054-00144ff88e88.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Status |
|---|
| 10544-919-14 | 10544091914 | 30 in 1 BOTTLE | Historical |