FENTANYL TRANSDERMAL SYSTEM
- Product NDC
- 42254-002
- 11-digit product format
- 422540002
- Labeler code
- 42254
- Product ID
- 42254-002_a7c456e6-403b-4aae-a576-60b106bf66a7
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- fentanyl transdermal system
- Dosage form
- PATCH, EXTENDED RELEASE
- Route
- TRANSDERMAL
- Labeler
- Rebel Distributors Corp.
- Application
- ANDA077154
- Marketing category
- ANDA
- Marketing start
- 2011-02-09
- Marketing end
- 0000-00-00
- Substance
- FENTANYL
- Active strength
- 50 ug/h
- Pharmacologic classes
- Full Opioid Agonists [MoA],Opioid Agonist [EPC]
- DEA schedule
- CII
- NDC exclude flag
- E
- Listing certified through
- 2017-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 42254-002-05 | FENTANYL TRANSDERMAL SYSTEM | 5 in 1 CARTON | PATCH, EXTENDED RELEASE | 5 | | 1 |
| 42254-002-05 | FENTANYL TRANSDERMAL SYSTEM | 1 in 1 POUCH | PATCH, EXTENDED RELEASE | 1 | | 1 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| FENTANYL | ACTIVE INGREDIENT | UF599785JZ | FENTANYL TRANSDERMAL SYSTEM PATCH, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP.] | 1 | |
| FENTANYL | ACTIVE MOIETY | UF599785JZ | FENTANYL TRANSDERMAL SYSTEM PATCH, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP.] | 1 | |
| DIMETHICONE | INACTIVE INGREDIENT | 92RU3N3Y1O | FENTANYL TRANSDERMAL SYSTEM PATCH, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP.] | 1 | |
| DIMETHICONE 350 | INACTIVE INGREDIENT | 2Y53S6ATLU | FENTANYL TRANSDERMAL SYSTEM PATCH, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP.] | 1 | |
| DIPROPYLENE GLYCOL | INACTIVE INGREDIENT | E107L85C40 | FENTANYL TRANSDERMAL SYSTEM PATCH, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP.] | 1 | |
| ETHYLENE-VINYL ACETATE COPOLYMER (19% VINYLACETATE) | INACTIVE INGREDIENT | JK6142KK4O | FENTANYL TRANSDERMAL SYSTEM PATCH, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP.] | 1 | |
| HEPTANE | INACTIVE INGREDIENT | 456148SDMJ | FENTANYL TRANSDERMAL SYSTEM PATCH, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP.] | 1 | |
| HYDROXYPROPYL CELLULOSE | INACTIVE INGREDIENT | RFW2ET671P | FENTANYL TRANSDERMAL SYSTEM PATCH, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP.] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 42254-002 | FENTANYL TRANSDERMAL SYSTEM PATCH, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP.] | 1 | Legacy NDC, 2 package rows | 20111118_a7c456e6-403b-4aae-a576-60b106bf66a7.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Status |
|---|
| 42254-002-05 | 42254000205 | 5 in 1 CARTON | Historical |