Indomethacin
- Product NDC
- 67296-0560
- 11-digit product format
- 672960560
- Labeler code
- 67296
- Product ID
- 67296-0560_08ca2c4e-2f88-4628-98c6-642874a35c48
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Indomethacin
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- RedPharm Drug Inc.
- Application
- ANDA018851
- Marketing category
- ANDA
- Marketing start
- 2007-04-01
- 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#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 234b5275-84d6-d169-e08f-554a8aed3f0a | Product name | 3 | 20250717 |
| 9aaf7cf4-60c3-b44f-e302-fd8b276c713b | Product name | 2 | 20250107 |
| c6b2f0e9-1a13-02e4-f789-55c724469f07 | Product name | 7 | 20171115 |
| 6e9718b9-62b9-458f-9408-30d688800922 | Product name | 1 | 20171103 |
| d62774ab-b1b9-2d5c-924f-1948e411ae15 | Product name | 3 | 20170816 |
| 97c70338-ee37-4c78-a047-53ee1cd9b53d | Product name | 1 | 20150616 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 67296-0560-1 | 2019-10-29 | C162847 | 48780-1 | 960f7f55-cfb3-8e05-e053-dbdaa90a074a | Indomethacin Capsules |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 67296-0560-1 | Indomethacin | 15 in 1 BOTTLE | CAPSULE | 15 | 1 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| Indomethacin | ACTIVE INGREDIENT | XXE1CET956 | INDOMETHACIN CAPSULE [REDPHARM DRUG INC.] | 1 | |
| Indomethacin | ACTIVE MOIETY | XXE1CET956 | INDOMETHACIN CAPSULE [REDPHARM DRUG INC.] | 1 | |
| D&C yellow no. 10 | INACTIVE INGREDIENT | 35SW5USQ3G | INDOMETHACIN CAPSULE [REDPHARM DRUG INC.] | 1 | |
| FD&C green no. 3 | INACTIVE INGREDIENT | 3P3ONR6O1S | INDOMETHACIN CAPSULE [REDPHARM DRUG INC.] | 1 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | INDOMETHACIN CAPSULE [REDPHARM DRUG INC.] | 1 | |
| lactose monohydrate | INACTIVE INGREDIENT | EWQ57Q8I5X | INDOMETHACIN CAPSULE [REDPHARM DRUG INC.] | 1 | |
| magnesium stearate | INACTIVE INGREDIENT | 70097M6I30 | INDOMETHACIN CAPSULE [REDPHARM DRUG INC.] | 1 | |
| polysorbate 80 | INACTIVE INGREDIENT | 6OZP39ZG8H | INDOMETHACIN CAPSULE [REDPHARM DRUG INC.] | 1 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | INDOMETHACIN CAPSULE [REDPHARM DRUG INC.] | 1 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 67296-0560 | INDOMETHACIN CAPSULE [REDPHARM DRUG INC.] | 1 | Legacy NDC, 1 package rows | 20110727_4077592a-8790-4d45-8cb6-2c95a0a929de.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 197818 | indomethacin 50 MG Oral Capsule | PSN | 4077592a-8790-4d45-8cb6-2c95a0a929de | 1 |
| 197818 | indomethacin 50 MG Oral Capsule | SCD | 4077592a-8790-4d45-8cb6-2c95a0a929de | 1 |
Packages#
| Package NDC | 11-digit format | Description | Status |
|---|---|---|---|
| 67296-0560-1 | 67296056001 | 15 in 1 BOTTLE | Historical |