BELBUCA
- Product NDC
- 55700-867
- 11-digit product format
- 557000867
- Labeler code
- 55700
- Product ID
- 55700-867_39e10902-3224-4e4b-8fac-51e39aa52b88
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- buprenorphine hydrochloride
- Dosage form
- FILM, SOLUBLE
- Route
- BUCCAL
- Labeler
- Quality Care Products, LLC
- Application
- NDA207932
- Marketing category
- NDA
- Marketing start
- 2020-06-02
- Marketing end
- 0000-00-00
- Substance
- BUPRENORPHINE HYDROCHLORIDE
- Active strength
- 450 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
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 |
|---|
| 55700-867-60 | 55700086760 | 60 POUCH in 1 BOX (55700-867-60) > 1 FILM, SOLUBLE in 1 POUCH | 60 pouch | 2020-06-02 | 0000-00-00 | No | No | Current |