Fentanyl Buccal
- Product NDC
- 51862-638
- 11-digit product format
- 518620638
- Labeler code
- 51862
- Product ID
- 51862-638_946972d3-b88b-4b7a-9d52-5010b846b6cb
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Fentanyl Citrate
- Dosage form
- TABLET
- Route
- BUCCAL; SUBLINGUAL
- Labeler
- Mayne Pharma
- Application
- NDA021947
- Marketing category
- NDA AUTHORIZED GENERIC
- Marketing start
- 2019-06-14
- Marketing end
- 0000-00-00
- Substance
- FENTANYL CITRATE
- Active strength
- 800 ug/1
- Pharmacologic classes
- Full Opioid Agonists [MoA],Opioid Agonist [EPC]
- DEA schedule
- CII
- NDC exclude flag
- No
- Listing certified through
- 2022-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 51862-638 | FENTANYL BUCCAL (FENTANYL CITRATE) TABLET [MAYNE PHARMA] | 11 | Legacy NDC | 20240222_918d0e2a-3af3-46e8-ad06-528263e03ba0.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 51862-638-28 | 51862063828 | 28 BLISTER PACK in 1 CARTON (51862-638-28) > 1 TABLET in 1 BLISTER PACK (51862-638-01) | 28 blister pack | 2019-06-14 | 0000-00-00 | No | No | Current |