INDOCIN
- Product NDC
- 69344-102
- 11-digit product format
- 693440102
- Labeler code
- 69344
- Product ID
- 69344-102_462a8532-9cea-682f-e063-6394a90a50e4
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Indomethacin
- Dosage form
- SUPPOSITORY
- Route
- RECTAL
- Labeler
- Zyla Life Sciences US Inc.
- Application
- ANDA073314
- Marketing category
- ANDA
- Marketing start
- 1992-08-31
- 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
- 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 | 50 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | XXE1CET956 |
| Rxcui | 197819, 206969 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 69344-102-33 | INDOCIN | 30 in 1 BOX | SUPPOSITORY | 30 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 69344-102 | INDOCIN (INDOMETHACIN) SUPPOSITORY [ZYLA LIFE SCIENCES US LLC] | 5 | Current NDC, Legacy NDC, 1 package rows | 20230729_3b36645c-de5e-4263-ae06-2f6ff6a9add2.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 |
|---|
| 69344-102-33 | 69344010233 | 30 SUPPOSITORY in 1 BOX (69344-102-33) | 30 suppository | 1992-08-31 | 0000-00-00 | No | No | Current |