Search by Drug Name or NDC
NDC 00143-9532-25 Dexmedetomidine HCl 100 ug/mL Details
Dexmedetomidine HCl 100 ug/mL
Dexmedetomidine HCl is a INTRAVENOUS INJECTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Hikma Pharmaceuticals USA Inc.. The primary component is DEXMEDETOMIDINE HYDROCHLORIDE.
Product Information
| NDC | 00143-9532 |
|---|---|
| Product ID | 0143-9532_27ff2cf4-825d-4e29-bd8d-ffccffa13c74 |
| Associated GPIs | 60206030102020 |
| GCN Sequence Number | 044671 |
| GCN Sequence Number Description | dexmedetomidine HCl VIAL 200MCG/2ML INTRAVEN |
| HIC3 | H2E |
| HIC3 Description | SEDATIVE-HYPNOTICS,NON-BARBITURATE |
| GCN | 42360 |
| HICL Sequence Number | 020971 |
| HICL Sequence Number Description | DEXMEDETOMIDINE HCL |
| Brand/Generic | Generic |
| Proprietary Name | Dexmedetomidine HCl |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Dexmedetomidine HCl |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | INJECTION |
| Route | INTRAVENOUS |
| Active Ingredient Strength | 100 |
| Active Ingredient Units | ug/mL |
| Substance Name | DEXMEDETOMIDINE HYDROCHLORIDE |
| Labeler Name | Hikma Pharmaceuticals USA 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 | ANDA205046 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 00143-9532-25 (00143953225)
| NDC Package Code | 0143-9532-25 |
|---|---|
| Billing NDC | 00143953225 |
| Package | 25 VIAL in 1 CARTON (0143-9532-25) / 2 mL in 1 VIAL (0143-9532-01) |
| Marketing Start Date | 2017-04-26 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |