Search by Drug Name or NDC
NDC 67457-0251-02 Dexmedetomidine 100 ug/mL Details
Dexmedetomidine 100 ug/mL
Dexmedetomidine is a INTRAVENOUS INJECTION, SOLUTION, CONCENTRATE in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Mylan Institutional LLC. The primary component is DEXMEDETOMIDINE HYDROCHLORIDE.
Product Information
NDC | 67457-0251 |
---|---|
Product ID | 67457-251_b10e25f7-8d56-4c7c-b8c0-6ed0aba9d260 |
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, CONCENTRATE |
Route | INTRAVENOUS |
Active Ingredient Strength | 100 |
Active Ingredient Units | ug/mL |
Substance Name | DEXMEDETOMIDINE HYDROCHLORIDE |
Labeler Name | Mylan Institutional LLC |
Pharmaceutical Class | Adrenergic alpha2-Agonists [MoA], Central alpha-2 Adrenergic Agonist [EPC], General Anesthesia [PE] |
DEA Schedule | n/a |
Marketing Category | ANDA |
Application Number | ANDA202881 |
Listing Certified Through | 2024-12-31 |
Package
NDC 67457-0251-02 (67457025102)
NDC Package Code | 67457-251-02 |
---|---|
Billing NDC | 67457025102 |
Package | 25 VIAL, GLASS in 1 CARTON (67457-251-02) / 2 mL in 1 VIAL, GLASS (67457-251-00) |
Marketing Start Date | 2014-08-18 |
NDC Exclude Flag | N |
Pricing Information | N/A |