Abstral
- Product NDC
- 42358-200
- 11-digit product format
- 423580200
- Labeler code
- 42358
- Product ID
- 42358-200_c6673375-386d-4fbe-ab79-1dd5c9a7c915
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- fentanyl citrate
- Dosage form
- TABLET, ORALLY DISINTEGRATING
- Route
- SUBLINGUAL
- Labeler
- Sentynl Therapeutics, Inc.
- Application
- NDA022510
- Marketing category
- NDA
- Marketing start
- 2016-10-01
- Marketing end
- 2022-04-30
- Substance
- FENTANYL CITRATE
- Active strength
- 200 ug/1
- Pharmacologic classes
- Full Opioid Agonists [MoA],Opioid Agonist [EPC]
- DEA schedule
- CII
- 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 |
|---|
| 42358-200-32 | 42358020032 | 8 BLISTER PACK in 1 CARTON (42358-200-32) > 4 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK | 8 blister pack | 2016-10-01 | 2022-04-30 | No | No | Current |