FENTANYL
- Product NDC
- 60505-7007
- 11-digit product format
- 605057007
- Labeler code
- 60505
- Product ID
- 60505-7007_3667df05-f059-309d-c2e7-1b1be5c9388e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- FENTANYL
- Dosage form
- PATCH, EXTENDED RELEASE
- Route
- TRANSDERMAL
- Labeler
- Apotex Corp.
- Application
- ANDA077449
- Marketing category
- ANDA
- Marketing start
- 2013-04-04
- Marketing end
- 2026-02-28
- Substance
- FENTANYL
- Active strength
- 50 ug/h
- 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
DailyMed Product Concepts#
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| FENTANYL | ACTIVE INGREDIENT | UF599785JZ | FENTANYL PATCH, EXTENDED RELEASE [APOTEX CORP.] | 5 | |
| FENTANYL | ACTIVE MOIETY | UF599785JZ | FENTANYL PATCH, EXTENDED RELEASE [APOTEX CORP.] | 5 | |
| ISOPROPYL MYRISTATE | INACTIVE INGREDIENT | 0RE8K4LNJS | FENTANYL PATCH, EXTENDED RELEASE [APOTEX CORP.] | 5 | |
| OCTYLDODECANOL | INACTIVE INGREDIENT | 461N1O614Y | FENTANYL PATCH, EXTENDED RELEASE [APOTEX CORP.] | 5 | |
| POLYBUTENE (1400 MW) | INACTIVE INGREDIENT | 1NA5AO9GH7 | FENTANYL PATCH, EXTENDED RELEASE [APOTEX CORP.] | 5 | |
| POLYISOBUTYLENE (800000 MW) | INACTIVE INGREDIENT | Y132ZOQ9H7 | FENTANYL PATCH, EXTENDED RELEASE [APOTEX CORP.] | 5 | |
| FENTANYL | ACTIVE INGREDIENT | UF599785JZ | FENTANYL PATCH, EXTENDED RELEASE [DIRECTRX] | 1 | |
| FENTANYL | ACTIVE MOIETY | UF599785JZ | FENTANYL PATCH, EXTENDED RELEASE [DIRECTRX] | 1 | |
| ISOPROPYL MYRISTATE | INACTIVE INGREDIENT | 0RE8K4LNJS | FENTANYL PATCH, EXTENDED RELEASE [DIRECTRX] | 1 | |
| OCTYLDODECANOL | INACTIVE INGREDIENT | 461N1O614Y | FENTANYL PATCH, EXTENDED RELEASE [DIRECTRX] | 1 | |
| POLYBUTENE (1400 MW) | INACTIVE INGREDIENT | 1NA5AO9GH7 | FENTANYL PATCH, EXTENDED RELEASE [DIRECTRX] | 1 | |
| POLYISOBUTYLENE (800000 MW) | INACTIVE INGREDIENT | Y132ZOQ9H7 | FENTANYL PATCH, EXTENDED RELEASE [DIRECTRX] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 60505-7007 | FENTANYL PATCH, EXTENDED RELEASE [APOTEX CORP.] | 17 | Legacy NDC | 20230714_0ff70df0-2cda-d96c-42a8-3bf180310498.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 60505-7007-2 | 60505700702 | 5 POUCH in 1 CARTON (60505-7007-2) > 1 PATCH in 1 POUCH (60505-7007-0) > 72 h in 1 PATCH | 5 pouch | 2013-04-04 | 0000-00-00 | No | No | Current |