Fentanyl
- Product NDC
- 68258-3040
- 11-digit product format
- 682583040
- Labeler code
- 68258
- Product ID
- 68258-3040_10d4c04c-52d8-4692-b1a7-660ddb87dff7
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Fentanyl
- Dosage form
- PATCH
- Route
- TRANSDERMAL
- Labeler
- Dispensing Solutions, Inc.
- Application
- NDA019813
- Marketing category
- NDA
- Marketing start
- 2004-10-01
- Marketing end
- 0000-00-00
- Substance
- FENTANYL
- Active strength
- 12 ug/1
- 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#
| 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 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 68258-3040-1 | 2019-10-29 | C162847 | 48780-1 | 960f7f55-bf6f-8e05-e053-dbdaa90a074a | FENTANYL TRANSDERMAL SYSTEM CII |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 68258-3040-1 | Fentanyl | 1 in 1 POUCH | PATCH | 1 | 1 | |
| 68258-3040-1 | Fentanyl | 5 in 1 BOX | PATCH | 5 | 1 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 68258-3040-1 | EA - Each | 68258-3040 | 3d521248-b731-487d-8b46-fb1ce67f726b | 1 | 2013-07-02 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| Fentanyl | ACTIVE INGREDIENT | UF599785JZ | FENTANYL PATCH [DISPENSING SOLUTIONS, INC.] | 1 | |
| Fentanyl | ACTIVE MOIETY | UF599785JZ | FENTANYL PATCH [DISPENSING SOLUTIONS, INC.] | 1 | |
| copovidone | INACTIVE INGREDIENT | D9C330MD8B | FENTANYL PATCH [DISPENSING SOLUTIONS, INC.] | 1 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 68258-3040 | FENTANYL PATCH [DISPENSING SOLUTIONS, INC.] | 1 | Legacy NDC, 2 package rows | 20110923_2a0092d8-f782-45ec-b8a8-c72156bbd5d5.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 577057 | fentaNYL 12 MCG/HR 72HR Transdermal System | PSN | 2a0092d8-f782-45ec-b8a8-c72156bbd5d5 | 1 |
| 577057 | 72 HR fentanyl 0.012 MG/HR Transdermal System | SCD | 2a0092d8-f782-45ec-b8a8-c72156bbd5d5 | 1 |
| 577057 | fentanyl 12 MCG/HR 3 Day Transdermal Patch | SY | 2a0092d8-f782-45ec-b8a8-c72156bbd5d5 | 1 |
| 577057 | fentanyl 12 MCG/HR 72HR Transdermal System | SY | 2a0092d8-f782-45ec-b8a8-c72156bbd5d5 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Status |
|---|---|---|---|
| 68258-3040-1 | 68258304001 | 1 in 1 POUCH | Historical |