BUPRENORPHINE AND NALOXONE
- Product NDC
- 0781-7227
- 11-digit product format
- 007817227
- Labeler code
- 0781
- Product ID
- 0781-7227_a6b7a3db-91a1-4334-9fea-63e33e845cfa
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- buprenorphine hydrochloride, naloxone hydrochloride
- Dosage form
- FILM, SOLUBLE
- Route
- BUCCAL; SUBLINGUAL
- Labeler
- Indivior Inc.
- Application
- NDA022410
- Marketing category
- NDA AUTHORIZED GENERIC
- Marketing start
- 2019-02-19
- Marketing end
- 2021-04-30
- Substance
- BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE
- Active strength
- 4 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
- 0000-00-00
- 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 |
|---|
| 0781-7227-64 | 00781722764 | 30 POUCH in 1 CARTON (0781-7227-64) > 1 FILM, SOLUBLE in 1 POUCH (0781-7227-06) | 30 pouch | 2019-02-19 | 2021-04-30 | No | No | Current |