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NDC 43066-0557-12 DEXMEDETOMIDINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE 400 ug/100mL Details
DEXMEDETOMIDINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE 400 ug/100mL
DEXMEDETOMIDINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE is a INTRAVENOUS INJECTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Baxter Healthcare Corporation. The primary component is DEXMEDETOMIDINE HYDROCHLORIDE.
Product Information
| NDC | 43066-0557 |
|---|---|
| Product ID | 43066-557_65a8c434-40f6-442a-9406-004f38d84fcf |
| 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 IN 0.9% SODIUM CHLORIDE |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | DEXMEDETOMIDINE HYDROCHLORIDE in 0.9% sodium chloride |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | INJECTION |
| Route | INTRAVENOUS |
| Active Ingredient Strength | 400 |
| Active Ingredient Units | ug/100mL |
| Substance Name | DEXMEDETOMIDINE HYDROCHLORIDE |
| Labeler Name | Baxter Healthcare Corporation |
| Pharmaceutical Class | Adrenergic alpha2-Agonists [MoA], Central alpha-2 Adrenergic Agonist [EPC], General Anesthesia [PE] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA208532 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 43066-0557-12 (43066055712)
| NDC Package Code | 43066-557-12 |
|---|---|
| Billing NDC | 43066055712 |
| Package | 12 BAG in 1 CARTON (43066-557-12) / 100 mL in 1 BAG |
| Marketing Start Date | 2019-08-27 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |