Indomethacin
- Product NDC
- 68084-411
- 11-digit product format
- 680840411
- Labeler code
- 68084
- Product ID
- 68084-411_423d8198-e51f-90c2-e063-6294a90a1de7
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Indomethacin
- Dosage form
- CAPSULE, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- American Health Packaging
- Application
- ANDA079175
- Marketing category
- ANDA
- Marketing start
- 2010-03-26
- Substance
- INDOMETHACIN
- Active strength
- 75 mg/1
- Pharmacologic classes
- Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Indomethacin
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| INDOMETHACIN | 75 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | XXE1CET956 |
| Rxcui | 310992 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68084-411-11 | Indomethacin | 1 in 1 BLISTER PACK | CAPSULE, EXTENDED RELEASE | 1 | | 10 |
| 68084-411-21 | Indomethacin | 30 in 1 BOX, UNIT-DOSE | CAPSULE, EXTENDED RELEASE | 30 | | 10 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| INDOMETHACIN | ACTIVE INGREDIENT | XXE1CET956 | INDOMETHACIN CAPSULE, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING] | 3 | |
| INDOMETHACIN | ACTIVE MOIETY | XXE1CET956 | INDOMETHACIN CAPSULE, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING] | 3 | |
| D&C YELLOW NO. 10 | INACTIVE INGREDIENT | 35SW5USQ3G | INDOMETHACIN CAPSULE, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING] | 3 | |
| GELATIN | INACTIVE INGREDIENT | 2G86QN327L | INDOMETHACIN CAPSULE, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING] | 3 | |
| MANNITOL | INACTIVE INGREDIENT | 3OWL53L36A | INDOMETHACIN CAPSULE, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING] | 3 | |
| POVIDONES | INACTIVE INGREDIENT | FZ989GH94E | INDOMETHACIN CAPSULE, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING] | 3 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | INDOMETHACIN CAPSULE, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING] | 3 | |
| SUCROSE | INACTIVE INGREDIENT | C151H8M554 | INDOMETHACIN CAPSULE, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING] | 3 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | INDOMETHACIN CAPSULE, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING] | 3 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | INDOMETHACIN CAPSULE, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING] | 3 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68084-411 | INDOMETHACIN CAPSULE, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING] | 9 | Current NDC, Legacy NDC, 2 package rows | 20241116_5a65b650-ea9b-4d0d-b62f-5971df1e62b4.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 68084-411-11 | 68084041111 | 1 in 1 BLISTER PACK | | | | | | Historical |
| 68084-411-21 | 68084041121 | 30 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-411-21) / 1 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK (68084-411-11) | 30 blister pack | 2010-03-26 | 0000-00-00 | No | No | Current |