buprenorphine hydrochloride
- Product NDC
- 63629-7125
- 11-digit product format
- 636297125
- Labeler code
- 63629
- Product ID
- 63629-7125_047cf3bf-65d9-4d3e-aaaa-4f5c5c9364a2
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- buprenorphine hydrochloride
- Dosage form
- TABLET
- Route
- SUBLINGUAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA090622
- Marketing category
- ANDA
- Marketing start
- 2010-09-24
- Marketing end
- 0000-00-00
- Substance
- BUPRENORPHINE HYDROCHLORIDE
- Active strength
- 2 mg/1
- Pharmacologic classes
- 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
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 63629-7125-1 | 63629712501 | 60 TABLET in 1 BOTTLE (63629-7125-1) | 60 tablet | 2016-10-31 | 0000-00-00 | No | No | Current |
| 63629-7125-2 | 63629712502 | 90 TABLET in 1 BOTTLE (63629-7125-2) | 90 tablet | 2016-10-31 | 0000-00-00 | No | No | Current |
| 63629-7125-3 | 63629712503 | 30 TABLET in 1 BOTTLE (63629-7125-3) | 30 tablet | 2017-04-21 | 0000-00-00 | No | No | Current |
| 63629-7125-4 | 63629712504 | 7 TABLET in 1 BOTTLE (63629-7125-4) | 7 tablet | 2022-09-02 | 0000-00-00 | No | No | Current |
| 63629-7125-5 | 63629712505 | 28 TABLET in 1 BOTTLE (63629-7125-5) | 28 tablet | 2022-09-02 | 0000-00-00 | No | No | Current |
| 63629-7125-6 | 63629712506 | 1 TABLET in 1 BOTTLE (63629-7125-6) | 1 tablet | 2022-09-02 | 0000-00-00 | No | No | Current |
| 63629-7125-7 | 63629712507 | 12 TABLET in 1 BOTTLE (63629-7125-7) | 12 tablet | 2022-09-02 | 0000-00-00 | No | No | Current |
| 63629-7125-8 | 63629712508 | 120 TABLET in 1 BOTTLE (63629-7125-8) | 120 tablet | 2022-09-02 | 0000-00-00 | No | No | Current |