FENTANYL TRANSDERMAL
- Product NDC
- 0406-9100
- 11-digit product format
- 004069100
- Labeler code
- 0406
- Product ID
- 0406-9100_35cb1ff2-8cbf-40cc-8e71-4040b0bdb64e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- fentanyl transdermal
- Dosage form
- PATCH, EXTENDED RELEASE
- Route
- TRANSDERMAL
- Labeler
- SpecGx LLC
- Application
- ANDA077154
- Marketing category
- ANDA
- Marketing start
- 2020-05-06
- Substance
- FENTANYL
- Active strength
- 100 ug/h
- Pharmacologic classes
- Full Opioid Agonists [MoA], Opioid Agonist [EPC]
- DEA schedule
- CII
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- FENTANYL TRANSDERMAL
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| FENTANYL | 100 ug/h |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | UF599785JZ |
| Rxcui | 197696, 245134, 245135, 245136, 577057, 1603495, 1603498 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0406-9100-76 | FENTANYL TRANSDERMAL | 1 in 1 POUCH | PATCH, EXTENDED RELEASE | 1 | | 58 |
| 0406-9100-76 | FENTANYL TRANSDERMAL | 5 in 1 CARTON | PATCH, EXTENDED RELEASE | 5 | | 58 |
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 [MALLINCKRODT, INC.] | 25 | |
| FENTANYL | ACTIVE MOIETY | UF599785JZ | FENTANYL TRANSDERMAL SYSTEM PATCH, EXTENDED RELEASE [MALLINCKRODT, INC.] | 25 | |
| DIMETHICONE | INACTIVE INGREDIENT | 92RU3N3Y1O | FENTANYL TRANSDERMAL SYSTEM PATCH, EXTENDED RELEASE [MALLINCKRODT, INC.] | 25 | |
| DIMETHICONE 350 | INACTIVE INGREDIENT | 2Y53S6ATLU | FENTANYL TRANSDERMAL SYSTEM PATCH, EXTENDED RELEASE [MALLINCKRODT, INC.] | 25 | |
| DIPROPYLENE GLYCOL | INACTIVE INGREDIENT | E107L85C40 | FENTANYL TRANSDERMAL SYSTEM PATCH, EXTENDED RELEASE [MALLINCKRODT, INC.] | 25 | |
| ETHYLENE-VINYL ACETATE COPOLYMER (19% VINYLACETATE) | INACTIVE INGREDIENT | JK6142KK4O | FENTANYL TRANSDERMAL SYSTEM PATCH, EXTENDED RELEASE [MALLINCKRODT, INC.] | 25 | |
| HEPTANE | INACTIVE INGREDIENT | 456148SDMJ | FENTANYL TRANSDERMAL SYSTEM PATCH, EXTENDED RELEASE [MALLINCKRODT, INC.] | 25 | |
| HYDROXYPROPYL CELLULOSE (TYPE H) | INACTIVE INGREDIENT | RFW2ET671P | FENTANYL TRANSDERMAL SYSTEM PATCH, EXTENDED RELEASE [MALLINCKRODT, INC.] | 25 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0406-9100 | FENTANYL TRANSDERMAL PATCH, EXTENDED RELEASE [SPECGX LLC] | 56 | Current NDC, Legacy NDC, 2 package rows | 20240515_e15a7e9b-8025-49dd-9a6d-bafcccf1959f.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 |
|---|
| 0406-9100-76 | 00406910076 | 5 POUCH in 1 CARTON (0406-9100-76) / 1 PATCH in 1 POUCH / 72 h in 1 PATCH | 5 pouch | 2020-05-06 | 0000-00-00 | No | No | Current |