NDC product
buprenorphine and naloxone
NDC 0054-0188 · Hikma Pharmaceuticals USA Inc.
Key facts
| Product NDC | 0054-0188 |
|---|---|
| Proprietary name | buprenorphine and naloxone |
| Nonproprietary name | buprenorphine and naloxone |
| Substances | BUPRENORPHINE HYDROCHLORIDE, NALOXONE HYDROCHLORIDE DIHYDRATE |
| Dosage form | TABLET |
| Route | SUBLINGUAL |
| Labeler | Hikma Pharmaceuticals USA Inc. |
| Product type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Application number | ANDA203326 |
| DEA schedule | CIII |
| Pharmacologic classes | Opioid Antagonist [EPC], Opioid Antagonists [MoA], Partial Opioid Agonist [EPC], Partial Opioid Agonists [MoA] |
| Marketing start | Jun 27, 2014 |
| 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: