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NDC 00781-3493-95 DEXMEDETOMIDINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE 4 ug/mL Details
DEXMEDETOMIDINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE 4 ug/mL
DEXMEDETOMIDINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE is a INTRAVENOUS INJECTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Sandoz Inc.. The primary component is DEXMEDETOMIDINE HYDROCHLORIDE.
Product Information
| NDC | 00781-3493 |
|---|---|
| Product ID | 0781-3493_fdf227d9-008e-60f8-e053-6294a90af5c4 |
| Associated GPIs | 60206030202010 |
| GCN Sequence Number | 073410 |
| GCN Sequence Number Description | dexmedetomidine in 0.9 % NaCl VIAL 80MCG/20ML INTRAVEN |
| HIC3 | H2E |
| HIC3 Description | SEDATIVE-HYPNOTICS,NON-BARBITURATE |
| GCN | 37807 |
| 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 | 4 |
| Active Ingredient Units | ug/mL |
| Substance Name | DEXMEDETOMIDINE HYDROCHLORIDE |
| Labeler Name | Sandoz Inc. |
| Pharmaceutical Class | Adrenergic alpha2-Agonists [MoA], Central alpha-2 Adrenergic Agonist [EPC], General Anesthesia [PE] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA209065 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 00781-3493-95 (00781349395)
| NDC Package Code | 0781-3493-95 |
|---|---|
| Billing NDC | 00781349395 |
| Package | 10 VIAL in 1 CARTON (0781-3493-95) / 20 mL in 1 VIAL |
| Marketing Start Date | 2020-06-12 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |