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NDC 00143-9525-10 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 Hikma Pharmaceuticals USA Inc.. The primary component is DEXMEDETOMIDINE HYDROCHLORIDE.
Product Information
| NDC | 00143-9525 |
|---|---|
| Product ID | 0143-9525_b8414657-909e-4ddb-8dbd-e0c3d15ac9c0 |
| 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 |
| 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 | 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 | ANDA206407 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 00143-9525-10 (00143952510)
| NDC Package Code | 0143-9525-10 |
|---|---|
| Billing NDC | 00143952510 |
| Package | 10 POUCH in 1 BAG (0143-9525-10) / 1 BAG in 1 POUCH / 100 mL in 1 BAG |
| Marketing Start Date | 2020-01-30 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |