Indomethacin
- Product NDC
- 10544-935
- 11-digit product format
- 105440935
- Labeler code
- 10544
- Product ID
- 10544-935_fe8ac746-b33c-4e12-aaa8-87773a42877f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Indomethacin
- Dosage form
- CAPSULE, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Blenheim Pharmacal, Inc.
- Application
- ANDA201807
- Marketing category
- ANDA
- Marketing start
- 2015-07-14
- 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 |
|---|
| 10544-935-14 | Indomethacin | 14 in 1 BOTTLE | CAPSULE, EXTENDED RELEASE | 14 | | 2 |
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.] | 2 | |
| INDOMETHACIN | ACTIVE MOIETY | XXE1CET956 | INDOMETHACIN CAPSULE, EXTENDED RELEASE [BLENHEIM PHARMACAL, INC.] | 2 | |
| ALCOHOL | INACTIVE INGREDIENT | 3K9958V90M | INDOMETHACIN CAPSULE, EXTENDED RELEASE [BLENHEIM PHARMACAL, INC.] | 2 | |
| AMMONIA | INACTIVE INGREDIENT | 5138Q19F1X | INDOMETHACIN CAPSULE, EXTENDED RELEASE [BLENHEIM PHARMACAL, INC.] | 2 | |
| BUTYL ALCOHOL | INACTIVE INGREDIENT | 8PJ61P6TS3 | INDOMETHACIN CAPSULE, EXTENDED RELEASE [BLENHEIM PHARMACAL, INC.] | 2 | |
| FERRIC OXIDE YELLOW | INACTIVE INGREDIENT | EX438O2MRT | INDOMETHACIN CAPSULE, EXTENDED RELEASE [BLENHEIM PHARMACAL, INC.] | 2 | |
| FERROSOFERRIC OXIDE | INACTIVE INGREDIENT | XM0M87F357 | INDOMETHACIN CAPSULE, EXTENDED RELEASE [BLENHEIM PHARMACAL, INC.] | 2 | |
| GELATIN | INACTIVE INGREDIENT | 2G86QN327L | INDOMETHACIN CAPSULE, EXTENDED RELEASE [BLENHEIM PHARMACAL, INC.] | 2 | |
| ISOPROPYL ALCOHOL | INACTIVE INGREDIENT | ND2M416302 | INDOMETHACIN CAPSULE, EXTENDED RELEASE [BLENHEIM PHARMACAL, INC.] | 2 | |
| MANNITOL | INACTIVE INGREDIENT | 3OWL53L36A | INDOMETHACIN CAPSULE, EXTENDED RELEASE [BLENHEIM PHARMACAL, INC.] | 2 | |
| POTASSIUM CATION | INACTIVE INGREDIENT | 295O53K152 | INDOMETHACIN CAPSULE, EXTENDED RELEASE [BLENHEIM PHARMACAL, INC.] | 2 | |
| POVIDONE | INACTIVE INGREDIENT | FZ989GH94E | INDOMETHACIN CAPSULE, EXTENDED RELEASE [BLENHEIM PHARMACAL, INC.] | 2 | |
| PROPYLENE GLYCOL | INACTIVE INGREDIENT | 6DC9Q167V3 | INDOMETHACIN CAPSULE, EXTENDED RELEASE [BLENHEIM PHARMACAL, INC.] | 2 | |
| SHELLAC | INACTIVE INGREDIENT | 46N107B71O | INDOMETHACIN CAPSULE, EXTENDED RELEASE [BLENHEIM PHARMACAL, INC.] | 2 | |
| SODIUM LAURYL SULFATE | INACTIVE INGREDIENT | 368GB5141J | INDOMETHACIN CAPSULE, EXTENDED RELEASE [BLENHEIM PHARMACAL, INC.] | 2 | |
| SUCROSE | INACTIVE INGREDIENT | C151H8M554 | INDOMETHACIN CAPSULE, EXTENDED RELEASE [BLENHEIM PHARMACAL, INC.] | 2 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | INDOMETHACIN CAPSULE, EXTENDED RELEASE [BLENHEIM PHARMACAL, INC.] | 2 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | INDOMETHACIN CAPSULE, EXTENDED RELEASE [BLENHEIM PHARMACAL, INC.] | 2 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 10544-935 | INDOMETHACIN CAPSULE, EXTENDED RELEASE [BLENHEIM PHARMACAL, INC.] | 2 | Legacy NDC, 1 package rows | 20151026_1b8ee98e-3905-0c53-e054-00144ff8d46c.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Status |
|---|
| 10544-935-14 | 10544093514 | 14 in 1 BOTTLE | Historical |