NDC product
Dexmedetomidine
NDC 68083-527 · Gland Pharma Limited
Key facts
| Product NDC | 68083-527 |
|---|---|
| Proprietary name | Dexmedetomidine |
| Nonproprietary name | Dexmedetomidine |
| Substances | DEXMEDETOMIDINE HYDROCHLORIDE |
| Dosage form | INJECTION, SOLUTION |
| Route | INTRAVENOUS |
| Labeler | Gland Pharma Limited |
| Product type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Application number | ANDA202126 |
| Pharmacologic classes | Adrenergic alpha2-Agonists [MoA], Central alpha-2 Adrenergic Agonist [EPC], General Anesthesia [PE] |
| Marketing start | Jun 28, 2021 |
| Listing certified through | Dec 31, 2027 |
At a glance
- 1–9 Package NDCs
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About National Drug Codes (NDC)
The National Drug Code (NDC) is the FDA's product identifier for drugs; the product NDC identifies the labeler and product, and each package adds a package code.
Source: U.S. Food and Drug Administration (FDA), National Drug Code Directory · Source date: