Indomethacin
- Product NDC
- 51655-443
- 11-digit product format
- 516550443
- Labeler code
- 51655
- Product ID
- 51655-443_4b444cf9-9cbb-c2aa-e063-6394a90a0512
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Indomethacin
- Dosage form
- CAPSULE, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Northwind Health Company, LLC
- Application
- ANDA201807
- Marketing category
- ANDA
- Marketing start
- 2020-09-30
- 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
- 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 | 75 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | XXE1CET956 |
| Rxcui | 310992 |
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 |
|---|
| 51655-443-52 | Indomethacin | 30 in 1 BOTTLE, PLASTIC | CAPSULE, EXTENDED RELEASE | 30 | | 4 |
| 51655-443-84 | Indomethacin | 14 in 1 BOTTLE, PLASTIC | CAPSULE, EXTENDED RELEASE | 14 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 51655-443 | INDOMETHACIN CAPSULE, EXTENDED RELEASE [NORTHWIND PHARMACEUTICALS, LLC] | 1 | Current NDC, 2 package rows | 20230418_f2f59f63-fcda-2a80-e053-2995a90ab087.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 51655-443-52 | 51655044352 | 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (51655-443-52) | 2020-09-30 | No | No | Current |
| 51655-443-84 | 51655044384 | 14 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (51655-443-84) | 2020-09-30 | No | No | Current |