Fentanyl
- Product NDC
- 0591-3212
- 11-digit product format
- 005913212
- Labeler code
- 0591
- Product ID
- 0591-3212_89a9c234-ef0a-4c40-8473-3ccd17c9640b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Fentanyl
- Dosage form
- PATCH, EXTENDED RELEASE
- Route
- TRANSDERMAL
- Labeler
- Actavis Pharma, Inc.
- Application
- ANDA076709
- Marketing category
- ANDA
- Marketing start
- 2007-08-21
- Marketing end
- 2019-09-30
- 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#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 77d14d2b-b9bf-4254-8dd6-c60dedb281d3 | Product name | 1 | 20231002 |
| a8df478d-5b88-9654-981b-87dff14dda8b | Product name | 2 | 20190801 |
| e9b48db2-e05b-8c2d-e4ac-a5a2efb26b57 | Product name | 2 | 20180118 |
| bb365072-425e-ca0a-021e-fd8b78162502 | Product name | 2 | 20161228 |
| 339915c8-cc8f-ceb4-1d3f-5ea267d21ea6 | Product name | 2 | 20160104 |
| 739fa0ac-b690-63c4-9904-e20dffbf78f9 | Product name | 1 | 20140508 |
| 7763fcbb-367d-ed06-b37f-e1529b6241be | Product name | 1 | 20140508 |
| d9ff6610-5d2e-d5c8-8a19-867d4a1efb77 | Product name | 1 | 20140508 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0591-3212-54 | EA - Each | 0591-3212 | e620a7e6-1cef-4d63-b384-2d04b68c0540 | 1 | 2012-07-24 |
| 0591-3212-72 | EA - Each | 0591-3212 | ebff54db-61a2-4f68-9d5a-3853b05e4de2 | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| FENTANYL | ACTIVE INGREDIENT | UF599785JZ | FENTANYL PATCH, EXTENDED RELEASE [STAT RX USA LLC] | 4 | |
| FENTANYL | ACTIVE MOIETY | UF599785JZ | FENTANYL PATCH, EXTENDED RELEASE [STAT RX USA LLC] | 4 | |
| ALCOHOL | INACTIVE INGREDIENT | 3K9958V90M | FENTANYL PATCH, EXTENDED RELEASE [STAT RX USA LLC] | 4 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 245134 | fentaNYL 25 MCG/HR 72HR Transdermal System | PSN | 9cb25b46-ca9a-4fb4-bf3d-a7d3074275d5 | 4 |
| 245135 | fentaNYL 50 MCG/HR 72HR Transdermal System | PSN | 9cb25b46-ca9a-4fb4-bf3d-a7d3074275d5 | 4 |
| 245134 | 72 HR fentanyl 0.025 MG/HR Transdermal System | SCD | 9cb25b46-ca9a-4fb4-bf3d-a7d3074275d5 | 4 |
| 245135 | 72 HR fentanyl 0.05 MG/HR Transdermal System | SCD | 9cb25b46-ca9a-4fb4-bf3d-a7d3074275d5 | 4 |
| 245134 | fentanyl 25 MCG/HR 3 Day Transdermal Patch | SY | 9cb25b46-ca9a-4fb4-bf3d-a7d3074275d5 | 4 |
| 245134 | fentanyl 25 MCG/HR 72HR Transdermal System | SY | 9cb25b46-ca9a-4fb4-bf3d-a7d3074275d5 | 4 |
| 245135 | fentanyl 50 MCG/HR 3 Day Transdermal Patch | SY | 9cb25b46-ca9a-4fb4-bf3d-a7d3074275d5 | 4 |
| 245135 | fentanyl 50 MCG/HR 72HR Transdermal System | SY | 9cb25b46-ca9a-4fb4-bf3d-a7d3074275d5 | 4 |