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NDC 00378-9127-98 FENTANYL 87.5 ug/h Details
FENTANYL 87.5 ug/h
FENTANYL is a TRANSDERMAL PATCH in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Mylan Pharmaceuticals Inc.. The primary component is FENTANYL.
MedlinePlus Drug Summary
Fentanyl patches are used to relieve severe pain in people who are expected to need pain medication around the clock for a long time and who cannot be treated with other medications. Fentanyl is in a class of medications called opiate (narcotic) analgesics. It works by changing the way the brain and nervous system respond to pain.
Related Packages: 00378-9127-98Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Fentanyl Transdermal Patch
Product Information
| NDC | 00378-9127 |
|---|---|
| Product ID | 0378-9127_87f6e135-d908-4279-b38c-d05597f3e882 |
| Associated GPIs | 65100025008645 |
| GCN Sequence Number | 073525 |
| GCN Sequence Number Description | fentanyl PATCH TD72 87.5MCG/HR TRANSDERM |
| HIC3 | H3A |
| HIC3 Description | OPIOID ANALGESICS |
| GCN | 37948 |
| HICL Sequence Number | 006438 |
| HICL Sequence Number Description | FENTANYL |
| Brand/Generic | Generic |
| Proprietary Name | FENTANYL |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | FENTANYL |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | PATCH |
| Route | TRANSDERMAL |
| Active Ingredient Strength | 87.5 |
| Active Ingredient Units | ug/h |
| Substance Name | FENTANYL |
| Labeler Name | Mylan Pharmaceuticals Inc. |
| Pharmaceutical Class | Full Opioid Agonists [MoA], Opioid Agonist [EPC] |
| DEA Schedule | CII |
| Marketing Category | ANDA |
| Application Number | ANDA076258 |
| Listing Certified Through | 2025-12-31 |
Package
NDC 00378-9127-98 (00378912798)
| NDC Package Code | 0378-9127-98 |
|---|---|
| Billing NDC | 00378912798 |
| Package | 5 POUCH in 1 CARTON (0378-9127-98) / 1 PATCH in 1 POUCH (0378-9127-16) / 72 h in 1 PATCH |
| Marketing Start Date | 2015-02-26 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |