Buprenorphene
- Product NDC
- 60505-7076
- 11-digit product format
- 605057076
- Labeler code
- 60505
- Product ID
- 60505-7076_a909ce6a-1e20-a839-6e2d-c86c782a6202
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Buprenorphene
- Dosage form
- PATCH, EXTENDED RELEASE
- Route
- TRANSDERMAL
- Labeler
- Apotex Corp.
- Application
- ANDA210272
- Marketing category
- ANDA
- Marketing start
- 2021-10-01
- Marketing end
- 0000-00-00
- Substance
- BUPRENORPHINE
- Active strength
- 8 ug/h
- 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 |
|---|
| 60505-7076-5 | 60505707605 | 4 POUCH in 1 CARTON (60505-7076-5) > 1 PATCH in 1 POUCH > 168 h in 1 PATCH | 4 pouch | 2021-09-29 | 0000-00-00 | No | No | Current |