Indomethacin
- Product NDC
- 65977-5042
- 11-digit product format
- 659775042
- Labeler code
- 65977
- Product ID
- 65977-5042_110aada7-dfe8-4ecf-80c7-4dac8907ad29
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Indomethacin
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Hetero Drugs Ltd.,
- Application
- ANDA091240
- Marketing category
- ANDA
- Marketing start
- 2011-04-12
- Marketing end
- 0000-00-00
- Substance
- INDOMETHACIN
- Active strength
- 25 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 |
|---|
| 65977-5042-0 | Indomethacin | 30 in 1 BOTTLE | CAPSULE | 30 | | 1 |
| 65977-5042-1 | Indomethacin | 100 in 1 BOTTLE | CAPSULE | 100 | | 1 |
| 65977-5042-2 | Indomethacin | 500 in 1 BOTTLE | CAPSULE | 500 | | 1 |
| 65977-5042-3 | Indomethacin | 1000 in 1 BOTTLE | CAPSULE | 1000 | | 1 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| INDOMETHACIN | ACTIVE INGREDIENT | XXE1CET956 | INDOMETHACIN CAPSULE [HETERO DRUGS LTD.,] | 1 | |
| INDOMETHACIN | ACTIVE MOIETY | XXE1CET956 | INDOMETHACIN CAPSULE [HETERO DRUGS LTD.,] | 1 | |
| COLLOIDAL SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | INDOMETHACIN CAPSULE [HETERO DRUGS LTD.,] | 1 | |
| D&C YELLOW NO. 10 | INACTIVE INGREDIENT | 35SW5USQ3G | INDOMETHACIN CAPSULE [HETERO DRUGS LTD.,] | 1 | |
| FD&C BLUE NO. 1 | INACTIVE INGREDIENT | H3R47K3TBD | INDOMETHACIN CAPSULE [HETERO DRUGS LTD.,] | 1 | |
| FERROSOFERRIC OXIDE | INACTIVE INGREDIENT | XM0M87F357 | INDOMETHACIN CAPSULE [HETERO DRUGS LTD.,] | 1 | |
| GELATIN | INACTIVE INGREDIENT | 2G86QN327L | INDOMETHACIN CAPSULE [HETERO DRUGS LTD.,] | 1 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | INDOMETHACIN CAPSULE [HETERO DRUGS LTD.,] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | INDOMETHACIN CAPSULE [HETERO DRUGS LTD.,] | 1 | |
| SODIUM LAURYL SULFATE | INACTIVE INGREDIENT | 368GB5141J | INDOMETHACIN CAPSULE [HETERO DRUGS LTD.,] | 1 | |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | INACTIVE INGREDIENT | 5856J3G2A2 | INDOMETHACIN CAPSULE [HETERO DRUGS LTD.,] | 1 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | INDOMETHACIN CAPSULE [HETERO DRUGS LTD.,] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 65977-5042 | INDOMETHACIN CAPSULE [HETERO DRUGS LTD.,] | 1 | Legacy NDC, 4 package rows | 20110512_110aada7-dfe8-4ecf-80c7-4dac8907ad29.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Status |
|---|
| 65977-5042-0 | 65977504200 | 30 in 1 BOTTLE | Historical |
| 65977-5042-1 | 65977504201 | 100 in 1 BOTTLE | Historical |
| 65977-5042-2 | 65977504202 | 500 in 1 BOTTLE | Historical |
| 65977-5042-3 | 65977504203 | 1000 in 1 BOTTLE | Historical |