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NDC 70121-1388-08 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 Amneal Pharmaceuticals LLC. The primary component is DEXMEDETOMIDINE HYDROCHLORIDE.
Product Information
| NDC | 70121-1388 |
|---|---|
| Product ID | 70121-1388_ae8803ae-20f2-4988-8671-6e64acd094bd |
| Associated GPIs | 60206030202020 |
| GCN Sequence Number | 070876 |
| GCN Sequence Number Description | dexmedetomidine in 0.9 % NaCl INFUS. BTL 200 MCG/50 INTRAVEN |
| HIC3 | H2E |
| HIC3 Description | SEDATIVE-HYPNOTICS,NON-BARBITURATE |
| GCN | 34538 |
| 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 | 4 |
| Active Ingredient Units | ug/mL |
| Substance Name | DEXMEDETOMIDINE HYDROCHLORIDE |
| Labeler Name | Amneal Pharmaceuticals 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 | ANDA207551 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 70121-1388-08 (70121138808)
| NDC Package Code | 70121-1388-8 |
|---|---|
| Billing NDC | 70121138808 |
| Package | 20 BOTTLE, GLASS in 1 CARTON (70121-1388-8) / 50 mL in 1 BOTTLE, GLASS (70121-1388-1) |
| Marketing Start Date | 2020-05-20 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |