Indomethacin
- Product NDC
- 70518-0515
- 11-digit product format
- 705180515
- Labeler code
- 70518
- Product ID
- 70518-0515_47f7927e-5acd-349f-e063-6294a90ae10e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Indomethacin
- Dosage form
- CAPSULE, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- REMEDYREPACK INC.
- Application
- ANDA201807
- Marketing category
- ANDA
- Marketing start
- 2017-05-10
- 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#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 70518-0515-0 | Indomethacin | 15 in 1 BOTTLE, PLASTIC | CAPSULE, EXTENDED RELEASE | 15 | | 23 |
| 70518-0515-1 | Indomethacin | 20 in 1 BOTTLE, PLASTIC | CAPSULE, EXTENDED RELEASE | 20 | | 23 |
| 70518-0515-2 | Indomethacin | 30 in 1 BOTTLE, PLASTIC | CAPSULE, EXTENDED RELEASE | 30 | | 23 |
| 70518-0515-3 | Indomethacin | 100 in 1 BOX | CAPSULE, EXTENDED RELEASE | 100 | | 23 |
| 70518-0515-4 | Indomethacin | 1 in 1 POUCH | CAPSULE, EXTENDED RELEASE | 1 | | 23 |
| 70518-0515-5 | Indomethacin | 25 in 1 BOTTLE, PLASTIC | CAPSULE, EXTENDED RELEASE | 25 | | 23 |
| 70518-0515-6 | Indomethacin | 100 in 1 BOX | CAPSULE, EXTENDED RELEASE | 100 | | 23 |
| 70518-0515-7 | Indomethacin | 1 in 1 POUCH | CAPSULE, EXTENDED RELEASE | 1 | | 23 |
| 70518-0515-8 | Indomethacin | 100 in 1 BOTTLE, PLASTIC | CAPSULE, EXTENDED RELEASE | 100 | | 23 |
| 70518-0515-9 | Indomethacin | 30 in 1 BOTTLE, PLASTIC | CAPSULE, EXTENDED RELEASE | 30 | | 23 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70518-0515 | INDOMETHACIN CAPSULE, EXTENDED RELEASE [REMEDYREPACK INC.] | 17 | Current NDC, Legacy NDC, 10 package rows | 20250427_b3d4fbff-d9d5-4dbb-bf01-ca2efc3bcf30.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 |
|---|
| 70518-0515-0 | 70518051500 | 15 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (70518-0515-0) | | 2017-05-10 | 0000-00-00 | No | No | Current |
| 70518-0515-1 | 70518051501 | 20 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (70518-0515-1) | | 2019-08-22 | 0000-00-00 | No | No | Current |
| 70518-0515-2 | 70518051502 | 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (70518-0515-2) | | 2020-03-10 | 0000-00-00 | No | No | Current |
| 70518-0515-3 | 70518051503 | 100 POUCH in 1 BOX (70518-0515-3) > 1 CAPSULE, EXTENDED RELEASE in 1 POUCH (70518-0515-4) | 100 pouch | 2020-10-22 | 0000-00-00 | No | No | Current |
| 70518-0515-4 | 70518051504 | 1 in 1 POUCH | | | | | | Historical |
| 70518-0515-5 | 70518051505 | 25 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (70518-0515-5) | | 2020-10-30 | 0000-00-00 | No | No | Current |
| 70518-0515-6 | 70518051506 | 100 in 1 BOX | | | | | | Historical |
| 70518-0515-7 | 70518051507 | 1 in 1 POUCH | | | | | | Historical |
| 70518-0515-8 | 70518051508 | 100 in 1 BOTTLE, PLASTIC | | | | | | Historical |
| 70518-0515-9 | 70518051509 | 30 in 1 BOTTLE, PLASTIC | | | | | | Historical |