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NDC 63323-0659-03 Indomethacin 1 mg/mL Details
Indomethacin 1 mg/mL
Indomethacin is a INTRAVENOUS INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Fresenius Kabi USA, LLC. The primary component is INDOMETHACIN.
Product Information
NDC | 63323-0659 |
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Product ID | 63323-659_f77a01f1-d5ef-4894-aba1-cd23e3ee4e7b |
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/mL |
Substance Name | INDOMETHACIN |
Labeler Name | Fresenius Kabi USA, LLC |
Pharmaceutical Class | Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC] |
DEA Schedule | n/a |
Marketing Category | NDA |
Application Number | NDA022536 |
Listing Certified Through | 2024-12-31 |
Package
NDC 63323-0659-03 (63323065903)
NDC Package Code | 63323-659-03 |
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Billing NDC | 63323065903 |
Package | 1 VIAL in 1 CARTON (63323-659-03) / 1 mL in 1 VIAL |
Marketing Start Date | 2010-03-19 |
NDC Exclude Flag | N |
Pricing Information | N/A |