Indomethacin
- Product NDC
- 43063-777
- 11-digit product format
- 430630777
- Labeler code
- 43063
- Product ID
- 43063-777_5259ea38-cc94-13aa-e063-6294a90a1efc
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Indomethacin
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- PD-Rx Pharmaceuticals, Inc.
- Application
- ANDA091240
- Marketing category
- ANDA
- Marketing start
- 2016-05-19
- Substance
- INDOMETHACIN
- Active strength
- 50 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
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Indomethacin
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| INDOMETHACIN | 50 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | XXE1CET956 |
| Rxcui | 197818 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 43063-777-20 | Indomethacin | 20 in 1 BOTTLE, PLASTIC | CAPSULE | 20 | | 15 |
| 43063-777-30 | Indomethacin | 30 in 1 BOTTLE, PLASTIC | CAPSULE | 30 | | 15 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 43063-777 | INDOMETHACIN CAPSULE [PD-RX PHARMACEUTICALS, INC.] | 14 | Current NDC, Legacy NDC, 2 package rows | 20250309_d66ada00-3ece-4b71-8c59-a0db48a2db80.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 |
|---|
| 43063-777-20 | 43063077720 | 20 CAPSULE in 1 BOTTLE, PLASTIC (43063-777-20) | 20 capsule | 2017-11-03 | 0000-00-00 | No | No | Current |
| 43063-777-30 | 43063077730 | 30 CAPSULE in 1 BOTTLE, PLASTIC (43063-777-30) | 30 capsule | 2017-08-01 | 0000-00-00 | No | No | Current |