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NDC 68382-0470-01 INDOMETHACIN 1 mg/1 Details
INDOMETHACIN 1 mg/1
INDOMETHACIN is a INTRAVENOUS INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Zydus Pharmaceuticals USA Inc.. The primary component is INDOMETHACIN SODIUM.
Product Information
| NDC | 68382-0470 |
|---|---|
| Product ID | 68382-470_37cff808-1732-462d-857b-6173382e5cba |
| Associated GPIs | 66100030102105 |
| GCN Sequence Number | 008335 |
| GCN Sequence Number Description | indomethacin sodium VIAL 1 MG INTRAVEN |
| HIC3 | A5A |
| HIC3 Description | PATENT DUCTUS ARTERIOSUS TREAT. AGENTS, NSAID-TYPE |
| GCN | 34690 |
| HICL Sequence Number | 003718 |
| HICL Sequence Number Description | INDOMETHACIN SODIUM |
| Brand/Generic | Generic |
| Proprietary Name | INDOMETHACIN |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | INDOMETHACIN |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION |
| Route | INTRAVENOUS |
| Active Ingredient Strength | 1 |
| Active Ingredient Units | mg/1 |
| Substance Name | INDOMETHACIN SODIUM |
| Labeler Name | Zydus Pharmaceuticals USA Inc. |
| Pharmaceutical Class | Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA206561 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 68382-0470-01 (68382047001)
| NDC Package Code | 68382-470-01 |
|---|---|
| Billing NDC | 68382047001 |
| Package | 1 VIAL in 1 CARTON (68382-470-01) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL |
| Marketing Start Date | 2021-05-15 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |