INDOMETHACIN EXTENDED-RELEASE is a Oral Capsule in the Human Prescription Drug category. It is labeled and distributed by H. J. Harkins Company Inc.. The primary component is Indomethacin.
| Product ID | 52959-082_60cd54b1-0806-8b86-e053-2a91aa0a1458 |
| NDC | 52959-082 |
| Product Type | Human Prescription Drug |
| Proprietary Name | INDOMETHACIN EXTENDED-RELEASE |
| Generic Name | Indomethacin Extended-release |
| Dosage Form | Capsule |
| Route of Administration | ORAL |
| Marketing Start Date | 2017-02-21 |
| Marketing Category | ANDA / ANDA |
| Application Number | ANDA202706 |
| Labeler Name | H. J. Harkins Company inc. |
| Substance Name | INDOMETHACIN |
| Active Ingredient Strength | 75 mg/1 |
| Pharm Classes | Cyclooxygenase Inhibitors [MoA],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC] |
| NDC Exclude Flag | N |
| Listing Certified Through | 2019-12-31 |
| Marketing Start Date | 2017-02-21 |
| NDC Exclude Flag | N |
| Sample Package? | N |
| Marketing Category | ANDA |
| Application Number | ANDA202706 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | EA |
| Marketing Start Date | 2017-02-21 |
| Inactivation Date | 2020-01-31 |
| Marketing Category | ANDA |
| Application Number | ANDA202706 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | EA |
| Marketing Start Date | 2017-02-21 |
| Inactivation Date | 2020-01-31 |
| Marketing Category | ANDA |
| Application Number | ANDA202706 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | EA |
| Marketing Start Date | 2017-02-21 |
| Inactivation Date | 2020-01-31 |
| Marketing Category | ANDA |
| Application Number | ANDA202706 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | EA |
| Marketing Start Date | 2017-02-21 |
| Inactivation Date | 2020-01-31 |
| Marketing Category | ANDA |
| Application Number | ANDA202706 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | EA |
| Marketing Start Date | 2017-02-21 |
| Inactivation Date | 2020-01-31 |
| Marketing Category | ANDA |
| Application Number | ANDA202706 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2017-02-21 |
| Inactivation Date | 2020-01-31 |
| Marketing Category | ANDA |
| Application Number | ANDA202706 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | EA |
| Marketing Start Date | 2017-02-21 |
| Inactivation Date | 2020-01-31 |
| Marketing Category | ANDA |
| Application Number | ANDA202706 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | EA |
| Marketing Start Date | 2017-02-21 |
| Inactivation Date | 2020-01-31 |
| Ingredient | Strength |
|---|---|
| INDOMETHACIN | 75 mg/1 |
| SPL SET ID: | 60cd54b1-0805-8b86-e053-2a91aa0a1458 |
| Manufacturer | |
| UNII | |
| RxNorm Concept Unique ID - RxCUI | |
| PHarm Class EPC | |
| NUI Code |
| NDC | Brand Name | Generic Name |
|---|---|---|
| 52959-082 | INDOMETHACIN EXTENDED-RELEASE | INDOMETHACIN EXTENDED-RELEASE |
| 59746-379 | Indomethacin extended-release | Indomethacin extended-release |
| 65862-684 | Indomethacin Extended-Release | Indomethacin Extended-Release |
| 68071-3174 | Indomethacin extended-release | Indomethacin extended-release |
| 68387-345 | Indomethacin extended-release | Indomethacin extended-release |
| 71335-0137 | Indomethacin extended-release | Indomethacin extended-release |