ACTIQ
- Product NDC
- 63459-504
- 11-digit product format
- 634590504
- Labeler code
- 63459
- Product ID
- 63459-504_3ffd9e45-cf0a-4204-b702-2aa38605a8b3
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Fentanyl Citrate
- Dosage form
- LOZENGE
- Route
- ORAL; TRANSMUCOSAL
- Labeler
- Cephalon, LLC
- Application
- NDA020747
- Marketing category
- NDA
- Marketing start
- 1999-01-20
- Marketing end
- 0000-00-00
- Substance
- FENTANYL CITRATE
- Active strength
- 400 ug/1
- Pharmacologic classes
- Full Opioid Agonists [MoA], Opioid Agonist [EPC]
- DEA schedule
- CII
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| FENTANYL CITRATE | ACTIVE INGREDIENT | MUN5LYG46H | ACTIQ (FENTANYL CITRATE) LOZENGE [CEPHALON, INC.] | 7 | |
| FENTANYL | ACTIVE MOIETY | UF599785JZ | ACTIQ (FENTANYL CITRATE) LOZENGE [CEPHALON, INC.] | 7 | |
| CITRIC ACID MONOHYDRATE | INACTIVE INGREDIENT | 2968PHW8QP | ACTIQ (FENTANYL CITRATE) LOZENGE [CEPHALON, INC.] | 7 | |
| DEXTRATES | INACTIVE INGREDIENT | G263MI44RU | ACTIQ (FENTANYL CITRATE) LOZENGE [CEPHALON, INC.] | 7 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | ACTIQ (FENTANYL CITRATE) LOZENGE [CEPHALON, INC.] | 7 | |
| SODIUM PHOSPHATE, DIBASIC | INACTIVE INGREDIENT | GR686LBA74 | ACTIQ (FENTANYL CITRATE) LOZENGE [CEPHALON, INC.] | 7 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | ACTIQ (FENTANYL CITRATE) LOZENGE [CEPHALON, INC.] | 7 | |
| SUCROSE | INACTIVE INGREDIENT | C151H8M554 | ACTIQ (FENTANYL CITRATE) LOZENGE [CEPHALON, INC.] | 7 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 63459-504 | ACTIQ (FENTANYL CITRATE) LOZENGE [CEPHALON, LLC] | 24 | Legacy NDC | 20240828_90b94524-f913-48b3-3771-7b2fcffd888a.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 63459-504-30 | 63459050430 | 30 BLISTER PACK in 1 CARTON (63459-504-30) > 1 LOZENGE in 1 BLISTER PACK (63459-504-01) | 30 blister pack | 1999-01-20 | 0000-00-00 | No | No | Current |