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NDC 55150-0297-10 Dexmedetomidine Hydrochloride 4 ug/mL Details
Dexmedetomidine Hydrochloride 4 ug/mL
Dexmedetomidine Hydrochloride is a INTRAVENOUS INJECTION, SOLUTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Eugia US LLC. The primary component is DEXMEDETOMIDINE HYDROCHLORIDE.
Product Information
| NDC | 55150-0297 |
|---|---|
| Product ID | 55150-297_cc0d3661-5f2e-43fb-a2ae-7d3f89c7e58c |
| Associated GPIs | 60206030202040 |
| GCN Sequence Number | 078788 |
| GCN Sequence Number Description | dexmedetomidine in 0.9 % NaCl PLAST. BAG 400MCG/100 INTRAVEN |
| HIC3 | H2E |
| HIC3 Description | SEDATIVE-HYPNOTICS,NON-BARBITURATE |
| GCN | 45179 |
| 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 in 0.9% Sodium Chloride |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | INJECTION, SOLUTION |
| Route | INTRAVENOUS |
| Active Ingredient Strength | 4 |
| Active Ingredient Units | ug/mL |
| Substance Name | DEXMEDETOMIDINE HYDROCHLORIDE |
| Labeler Name | Eugia US 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 | ANDA210321 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 55150-0297-10 (55150029710)
| NDC Package Code | 55150-297-10 |
|---|---|
| Billing NDC | 55150029710 |
| Package | 10 POUCH in 1 CARTON (55150-297-10) / 1 BAG in 1 POUCH / 100 mL in 1 BAG |
| Marketing Start Date | 2020-12-07 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |