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NDC 68382-0124-25 DEXMEDETOMIDINE HYDROCHLORIDE 100 ug/mL Details
DEXMEDETOMIDINE HYDROCHLORIDE 100 ug/mL
DEXMEDETOMIDINE HYDROCHLORIDE is a INTRAVENOUS INJECTION, SOLUTION, CONCENTRATE in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Zydus Pharmaceuticals USA Inc.. The primary component is DEXMEDETOMIDINE HYDROCHLORIDE.
Product Information
| NDC | 68382-0124 |
|---|---|
| Product ID | 68382-124_e8989b43-f766-4563-92e4-5bd26365ef17 |
| Associated GPIs | |
| GCN Sequence Number | n/a |
| GCN Sequence Number Description | n/a |
| HIC3 | n/a |
| HIC3 Description | n/a |
| GCN | n/a |
| HICL Sequence Number | n/a |
| HICL Sequence Number Description | n/a |
| Brand/Generic | n/a |
| Proprietary Name | DEXMEDETOMIDINE HYDROCHLORIDE |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | dexmedetomidine hydrochloride |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | INJECTION, SOLUTION, CONCENTRATE |
| Route | INTRAVENOUS |
| Active Ingredient Strength | 100 |
| Active Ingredient Units | ug/mL |
| Substance Name | DEXMEDETOMIDINE HYDROCHLORIDE |
| Labeler Name | Zydus Pharmaceuticals USA 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 | ANDA206798 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 68382-0124-25 (68382012425)
| NDC Package Code | 68382-124-25 |
|---|---|
| Billing NDC | 68382012425 |
| Package | 25 VIAL in 1 CARTON (68382-124-25) / 2 mL in 1 VIAL (68382-124-01) |
| Marketing Start Date | 2018-06-14 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |