buprenorphine buccal film
- Product NDC
- 47781-475
- 11-digit product format
- 477810475
- Labeler code
- 47781
- Product ID
- 47781-475_62b1a9fe-2e29-1535-e7d6-327240efa309
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- buprenorphine buccal
- Dosage form
- FILM
- Route
- BUCCAL
- Labeler
- Alvogen, Inc.
- Application
- ANDA211594
- Marketing category
- ANDA
- Marketing start
- 2021-08-04
- Marketing end
- 0000-00-00
- Substance
- BUPRENORPHINE HYDROCHLORIDE
- Active strength
- 900 ug/1
- Pharmacologic classes
- Partial Opioid Agonists [MoA],Partial Opioid Agonist [EPC]
- DEA schedule
- CIII
- NDC exclude flag
- No
- Listing certified through
- 2022-12-31
- 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 |
|---|
| 47781-475-74 | 47781047574 | 60 POUCH in 1 CARTON (47781-475-74) > 1 FILM in 1 POUCH (47781-475-11) | 60 pouch | 2021-08-04 | 0000-00-00 | No | No | Current |