Buprenorphine Hydrochloride and Naloxone Hydrochloride Dihydrate
- Product NDC
- 55700-901
- 11-digit product format
- 557000901
- Labeler code
- 55700
- Product ID
- 55700-901_91718a43-9247-4971-aa74-07dd5dd4fba6
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Buprenorphine Hydrochloride and Naloxone Hydrochloride Dihydrate
- Dosage form
- TABLET
- Route
- SUBLINGUAL
- Labeler
- Quality Care Products, LLC
- Application
- ANDA207000
- Marketing category
- ANDA
- Marketing start
- 2021-03-03
- Marketing end
- 0000-00-00
- Substance
- BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE DIHYDRATE
- Active strength
- 2 mg/1; mg/1
- Pharmacologic classes
- Partial Opioid Agonists [MoA],Partial Opioid Agonist [EPC],Opioid Antagonist [EPC],Opioid Antagonists [MoA]
- DEA schedule
- CIII
- NDC exclude flag
- No
- Listing certified through
- 2022-12-31
- Current FDA listing
- Historical FDA.report record
FDA-Initiated Inactive NDC Indexing#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 55700-901-30 | 55700090130 | 30 TABLET in 1 BOTTLE, PLASTIC (55700-901-30) | 30 tablet | 2021-03-03 | 0000-00-00 | No | No | Current |