NDC product
Buprenorphine Hydrochloride and Naloxone Hydrochloride Dihydrate
NDC 0406-8005 · SpecGx LLC
Key facts
| Product NDC | 0406-8005 |
|---|---|
| Proprietary name | Buprenorphine Hydrochloride and Naloxone Hydrochloride Dihydrate |
| Nonproprietary name | Buprenorphine Hydrochloride and Naloxone Hydrochloride Dihydrate |
| Substances | BUPRENORPHINE HYDROCHLORIDE, NALOXONE HYDROCHLORIDE DIHYDRATE |
| Dosage form | TABLET |
| Route | SUBLINGUAL |
| Labeler | SpecGx LLC |
| Product type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Application number | ANDA207000 |
| DEA schedule | CIII |
| Pharmacologic classes | Opioid Antagonist [EPC], Opioid Antagonists [MoA], Partial Opioid Agonist [EPC], Partial Opioid Agonists [MoA] |
| Marketing start | Dec 13, 2017 |
| 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: