INDOMETHACIN
- Product NDC
- 61919-344
- 11-digit product format
- 619190344
- Labeler code
- 61919
- Product ID
- 61919-344_b63acc57-8efe-4413-b4c0-ff35a197c733
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- INDOMETHACIN
- Dosage form
- CAPSULE, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Direct RX
- Application
- ANDA201807
- Marketing category
- ANDA
- Marketing start
- 2015-01-01
- 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 |
|---|
| 61919-344-60 | INDOMETHACIN | 60 in 1 BOTTLE | CAPSULE, EXTENDED RELEASE | 60 | | 1 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| INDOMETHACIN | ACTIVE INGREDIENT | XXE1CET956 | INDOMETHACIN CAPSULE, EXTENDED RELEASE [DIRECT RX] | 1 | |
| INDOMETHACIN | ACTIVE MOIETY | XXE1CET956 | INDOMETHACIN CAPSULE, EXTENDED RELEASE [DIRECT RX] | 1 | |
| ALCOHOL | INACTIVE INGREDIENT | 3K9958V90M | INDOMETHACIN CAPSULE, EXTENDED RELEASE [DIRECT RX] | 1 | |
| AMMONIA | INACTIVE INGREDIENT | 5138Q19F1X | INDOMETHACIN CAPSULE, EXTENDED RELEASE [DIRECT RX] | 1 | |
| BUTYL ALCOHOL | INACTIVE INGREDIENT | 8PJ61P6TS3 | INDOMETHACIN CAPSULE, EXTENDED RELEASE [DIRECT RX] | 1 | |
| FERRIC OXIDE YELLOW | INACTIVE INGREDIENT | EX438O2MRT | INDOMETHACIN CAPSULE, EXTENDED RELEASE [DIRECT RX] | 1 | |
| FERROSOFERRIC OXIDE | INACTIVE INGREDIENT | XM0M87F357 | INDOMETHACIN CAPSULE, EXTENDED RELEASE [DIRECT RX] | 1 | |
| GELATIN | INACTIVE INGREDIENT | 2G86QN327L | INDOMETHACIN CAPSULE, EXTENDED RELEASE [DIRECT RX] | 1 | |
| ISOPROPYL ALCOHOL | INACTIVE INGREDIENT | ND2M416302 | INDOMETHACIN CAPSULE, EXTENDED RELEASE [DIRECT RX] | 1 | |
| MANNITOL | INACTIVE INGREDIENT | 3OWL53L36A | INDOMETHACIN CAPSULE, EXTENDED RELEASE [DIRECT RX] | 1 | |
| POTASSIUM CATION | INACTIVE INGREDIENT | 295O53K152 | INDOMETHACIN CAPSULE, EXTENDED RELEASE [DIRECT RX] | 1 | |
| POVIDONE | INACTIVE INGREDIENT | FZ989GH94E | INDOMETHACIN CAPSULE, EXTENDED RELEASE [DIRECT RX] | 1 | |
| PROPYLENE GLYCOL | INACTIVE INGREDIENT | 6DC9Q167V3 | INDOMETHACIN CAPSULE, EXTENDED RELEASE [DIRECT RX] | 1 | |
| SHELLAC | INACTIVE INGREDIENT | 46N107B71O | INDOMETHACIN CAPSULE, EXTENDED RELEASE [DIRECT RX] | 1 | |
| SODIUM LAURYL SULFATE | INACTIVE INGREDIENT | 368GB5141J | INDOMETHACIN CAPSULE, EXTENDED RELEASE [DIRECT RX] | 1 | |
| SUCROSE | INACTIVE INGREDIENT | C151H8M554 | INDOMETHACIN CAPSULE, EXTENDED RELEASE [DIRECT RX] | 1 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | INDOMETHACIN CAPSULE, EXTENDED RELEASE [DIRECT RX] | 1 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | INDOMETHACIN CAPSULE, EXTENDED RELEASE [DIRECT RX] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 61919-344 | INDOMETHACIN CAPSULE, EXTENDED RELEASE [DIRECT RX] | 1 | Legacy NDC, 1 package rows | 20150702_ef9444e9-fc20-4139-ae74-ae9268e44a21.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Status |
|---|
| 61919-344-60 | 61919034460 | 60 in 1 BOTTLE | Historical |