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NDC 67457-0924-50 DEXMEDETOMIDINE HYDROCHLORIDE 200 ug/50mL Details
DEXMEDETOMIDINE HYDROCHLORIDE 200 ug/50mL
DEXMEDETOMIDINE HYDROCHLORIDE is a INTRAVENOUS INJECTION, SOLUTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Mylan Institutional LLC. The primary component is DEXMEDETOMIDINE HYDROCHLORIDE.
Product Information
NDC | 67457-0924 |
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Product ID | 67457-924_f90516a4-b48a-49fe-a410-104fe484af08 |
Associated GPIs | 60206030202020 |
GCN Sequence Number | 070876 |
GCN Sequence Number Description | dexmedetomidine in 0.9 % NaCl INFUS. BTL 200 MCG/50 INTRAVEN |
HIC3 | H2E |
HIC3 Description | SEDATIVE-HYPNOTICS,NON-BARBITURATE |
GCN | 34538 |
HICL Sequence Number | 040230 |
HICL Sequence Number Description | DEXMEDETOMIDINE HCL IN 0.9 % SODIUM CHLORIDE |
Brand/Generic | Generic |
Proprietary Name | DEXMEDETOMIDINE HYDROCHLORIDE |
Proprietary Name Suffix | n/a |
Non-Proprietary Name | DEXMEDETOMIDINE HYDROCHLORIDE |
Product Type | HUMAN PRESCRIPTION DRUG |
Dosage Form | INJECTION, SOLUTION |
Route | INTRAVENOUS |
Active Ingredient Strength | 200 |
Active Ingredient Units | ug/50mL |
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 | ANDA212571 |
Listing Certified Through | 2024-12-31 |
Package
NDC 67457-0924-50 (67457092450)
NDC Package Code | 67457-924-50 |
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Billing NDC | 67457092450 |
Package | 20 BOTTLE in 1 CARTON (67457-924-50) / 50 mL in 1 BOTTLE (67457-924-00) |
Marketing Start Date | 2020-11-13 |
NDC Exclude Flag | N |
Pricing Information | N/A |