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NDC 67457-0925-10 DEXMEDETOMIDINE HYDROCHLORIDE 400 ug/100mL Details
DEXMEDETOMIDINE HYDROCHLORIDE 400 ug/100mL
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 | 67457-0925 |
|---|---|
| Product ID | 67457-925_f90516a4-b48a-49fe-a410-104fe484af08 |
| Associated GPIs | 60206030202040 |
| GCN Sequence Number | 070877 |
| GCN Sequence Number Description | dexmedetomidine in 0.9 % NaCl INFUS. BTL 400MCG/100 INTRAVEN |
| HIC3 | H2E |
| HIC3 Description | SEDATIVE-HYPNOTICS,NON-BARBITURATE |
| GCN | 34539 |
| 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 | 400 |
| Active Ingredient Units | ug/100mL |
| 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 67457-0925-10 (67457092510)
| NDC Package Code | 67457-925-10 |
|---|---|
| Billing NDC | 67457092510 |
| Package | 10 BOTTLE in 1 CARTON (67457-925-10) / 100 mL in 1 BOTTLE (67457-925-00) |
| Marketing Start Date | 2020-11-13 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |