| NDC Code | 0338-9557-12 | 
|---|
			| Package Description | 12 BAG in 1 CARTON (0338-9557-12)  / 100 mL in 1 BAG | 
|---|
			| Product NDC | 0338-9557 | 
|---|
			| Product Type Name | HUMAN PRESCRIPTION DRUG | 
|---|
			| Proprietary Name | Dexmedetomidine Hydrochloride | 
|---|
			
			| Non-Proprietary Name | Dexmedetomidine Hydrochloride | 
|---|
			| Dosage Form | INJECTION | 
|---|
			| Usage | INTRAVENOUS | 
|---|
			| Start Marketing Date | 20180821 | 
|---|
			
			| Marketing Category Name | ANDA | 
|---|
			| Application Number | ANDA208532 | 
|---|
			| Manufacturer | Baxter Healthcare Company | 
|---|
			| Substance Name | DEXMEDETOMIDINE HYDROCHLORIDE | 
|---|
			| Strength | 400 | 
|---|
			| Strength Unit | ug/100mL | 
|---|
			| Pharmacy Classes | Adrenergic alpha2-Agonists [MoA], Central alpha-2 Adrenergic Agonist [EPC], General Anesthesia [PE] | 
|---|