Fentanyl
- Product NDC
- 52959-585
- 11-digit product format
- 529590585
- Labeler code
- 52959
- Product ID
- 52959-585_62e84ab2-d304-4595-a918-6939ea7cc7b7
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- fentanyl
- Dosage form
- PATCH, EXTENDED RELEASE
- Route
- TRANSDERMAL
- Labeler
- H.J. Harkins Company, Inc.
- Application
- ANDA077775
- Marketing category
- ANDA
- Marketing start
- 2010-03-01
- Marketing end
- 0000-00-00
- Substance
- FENTANYL
- Active strength
- 25 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 |
|---|
| 52959-585-05 | Fentanyl | 1 in 1 POUCH | PATCH, EXTENDED RELEASE | 1 | | 3 |
| 52959-585-05 | Fentanyl | 5 in 1 CARTON | PATCH, EXTENDED RELEASE | 5 | | 3 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| FENTANYL | ACTIVE INGREDIENT | UF599785JZ | FENTANYL PATCH, EXTENDED RELEASE [H.J. HARKINS COMPANY, INC.] | 3 | |
| FENTANYL | ACTIVE MOIETY | UF599785JZ | FENTANYL PATCH, EXTENDED RELEASE [H.J. HARKINS COMPANY, INC.] | 3 | |
| ISOPROPYL MYRISTATE | INACTIVE INGREDIENT | 0RE8K4LNJS | FENTANYL PATCH, EXTENDED RELEASE [H.J. HARKINS COMPANY, INC.] | 3 | |
| MINERAL OIL | INACTIVE INGREDIENT | T5L8T28FGP | FENTANYL PATCH, EXTENDED RELEASE [H.J. HARKINS COMPANY, INC.] | 3 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 52959-585 | FENTANYL PATCH, EXTENDED RELEASE [H.J. HARKINS COMPANY, INC.] | 3 | Legacy NDC, 2 package rows | 20120120_1bee6f20-2d81-4e03-908f-ec9b004f49d8.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Status |
|---|
| 52959-585-05 | 52959058505 | 1 in 1 POUCH | Historical |