DailyMed label
Buprenorphine Hydrochloride and Naloxone Hydrochloride Dihydrate
DailyMed label · SpecGx LLC · version 34
Key facts
| Product | Buprenorphine Hydrochloride and Naloxone Hydrochloride Dihydrate |
|---|---|
| Labeler | SpecGx LLC |
| Document type | HUMAN PRESCRIPTION DRUG LABEL |
| Active ingredients | BUPRENORPHINE HYDROCHLORIDE, NALOXONE HYDROCHLORIDE DIHYDRATE |
| Active ingredient UNIIs | 56W8MW3EN1, 5Q187997EE |
| Application number | 207000 |
| Route | SUBLINGUAL |
| DEA schedule | CIII |
| NDC package codes | 0406-8005-03, 0406-8020-03 |
| Effective date | Jun 10, 2026 |
| Set ID | 62abde41-46cb-4e90-a798-23d6531bf9aa |
At a glance
- 1–9 NDC package codes
- 1–9 Active ingredients
- None Manufacturing establishments listed
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About DailyMed drug labels
DailyMed publishes the structured product labeling (SPL) that companies submit to the FDA, including package NDCs, ingredients and the establishments that make each product.
Source: U.S. National Library of Medicine (NLM), DailyMed · Source date: