Buprenorphine and Naloxone
- Product NDC
- 63629-7270
- 11-digit product format
- 636297270
- Labeler code
- 63629
- Product ID
- 63629-7270_2dfda9b4-25d2-4bc8-8a09-cd1e683f05e2
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- buprenorphine hydrochloride and naloxone hydrochloride
- Dosage form
- TABLET
- Route
- SUBLINGUAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA204431
- Marketing category
- ANDA
- Marketing start
- 2016-01-07
- Marketing end
- 0000-00-00
- Substance
- BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE
- Active strength
- 2 mg/1; mg/1
- Pharmacologic classes
- Opioid Antagonist [EPC], Opioid Antagonists [MoA], Partial Opioid Agonist [EPC], Partial Opioid Agonists [MoA]
- DEA schedule
- CIII
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- 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 |
|---|
| 63629-7270-1 | 63629727001 | 30 TABLET in 1 BOTTLE (63629-7270-1) | 30 tablet | 2022-09-02 | 0000-00-00 | No | No | Current |
| 63629-7270-2 | 63629727002 | 10 TABLET in 1 BOTTLE (63629-7270-2) | 10 tablet | 2022-09-02 | 0000-00-00 | No | No | Current |