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NDC 71288-0505-03 DEXMEDETOMIDINE 100 ug/mL Details
DEXMEDETOMIDINE 100 ug/mL
DEXMEDETOMIDINE is a INTRAVENOUS INJECTION, SOLUTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Meitheal Pharmaceuticals Inc.. The primary component is DEXMEDETOMIDINE HYDROCHLORIDE.
Product Information
| NDC | 71288-0505 |
|---|---|
| Product ID | 71288-505_74e25a75-2d63-4f39-b6d0-a73392bd1040 |
| Associated GPIs | 60206030102020 |
| GCN Sequence Number | 044671 |
| GCN Sequence Number Description | dexmedetomidine HCl VIAL 200MCG/2ML INTRAVEN |
| HIC3 | H2E |
| HIC3 Description | SEDATIVE-HYPNOTICS,NON-BARBITURATE |
| GCN | 42360 |
| HICL Sequence Number | 020971 |
| HICL Sequence Number Description | DEXMEDETOMIDINE HCL |
| Brand/Generic | Generic |
| Proprietary Name | DEXMEDETOMIDINE |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | DEXMEDETOMIDINE |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | INJECTION, SOLUTION |
| Route | INTRAVENOUS |
| Active Ingredient Strength | 100 |
| Active Ingredient Units | ug/mL |
| Substance Name | DEXMEDETOMIDINE HYDROCHLORIDE |
| Labeler Name | Meitheal Pharmaceuticals Inc. |
| Pharmaceutical Class | Adrenergic alpha2-Agonists [MoA], Central alpha-2 Adrenergic Agonist [EPC], General Anesthesia [PE] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA204843 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 71288-0505-03 (71288050503)
| NDC Package Code | 71288-505-03 |
|---|---|
| Billing NDC | 71288050503 |
| Package | 25 VIAL, SINGLE-DOSE in 1 CARTON (71288-505-03) / 2 mL in 1 VIAL, SINGLE-DOSE (71288-505-02) |
| Marketing Start Date | 2019-01-18 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |