Indocin
- Product NDC
- 69344-101
- 11-digit product format
- 693440101
- Labeler code
- 69344
- Product ID
- 69344-101_58959f55-f324-4433-97fc-c3b1b7c199be
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- indomethacin
- Dosage form
- SUSPENSION
- Route
- ORAL
- Labeler
- Zyla Life Sciences US LLC
- Application
- NDA018332
- Marketing category
- NDA
- Marketing start
- 2019-02-04
- Substance
- INDOMETHACIN
- Active strength
- 25 mg/5mL
- 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
- Indocin
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| INDOMETHACIN | 25 mg/5mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | XXE1CET956 |
| Rxcui | 206971, 310991 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 69344-101-01 | Indocin | 237 mL in 1 BOTTLE, GLASS | SUSPENSION | 237 | | 5 |
| 69344-101-01 | Indocin | 1 in 1 CARTON | SUSPENSION | 1 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 69344-101 | INDOCIN (INDOMETHACIN) SUSPENSION [ZYLA LIFE SCIENCES US LLC] | 5 | Current NDC, Legacy NDC, 2 package rows | 20241219_73878376-1d24-423b-9f37-3666e83c95da.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 69344-101-01 | 69344010101 | 1 BOTTLE, GLASS in 1 CARTON (69344-101-01) / 237 mL in 1 BOTTLE, GLASS | 2019-02-04 | 0000-00-00 | No | No | Current |