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NDC 63459-0516-30 ACTIQ 1600 ug/1 Details
ACTIQ 1600 ug/1
ACTIQ is a ORAL; TRANSMUCOSAL LOZENGE in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Cephalon, LLC. The primary component is FENTANYL CITRATE.
MedlinePlus Drug Summary
Fentanyl is used to treat breakthrough pain (sudden episodes of pain that occur despite round the clock treatment with pain medication) in cancer patients at least 18 years of age (or at least 16 years of age if using Actiq brand lozenges) who are taking regularly scheduled doses of another narcotic (opiate) pain medication, and who are tolerant (used to the effects of the medication) to narcotic pain medications. Fentanyl is in a class of medications called narcotic (opiate) analgesics. It works by changing the way the brain and nervous system respond to pain.
Related Packages: 63459-0516-30Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Fentanyl
Product Information
| NDC | 63459-0516 |
|---|---|
| Product ID | 63459-516_28b6e3d8-c97c-4946-ae6e-63459ad749f1 |
| Associated GPIs | 65100025108485 |
| GCN Sequence Number | 041342 |
| GCN Sequence Number Description | fentanyl citrate LOZENGE HD 1600 MCG BUCCAL |
| HIC3 | H3A |
| HIC3 Description | OPIOID ANALGESICS |
| GCN | 19194 |
| HICL Sequence Number | 001747 |
| HICL Sequence Number Description | FENTANYL CITRATE |
| Brand/Generic | Brand |
| Proprietary Name | ACTIQ |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Fentanyl Citrate |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | LOZENGE |
| Route | ORAL; TRANSMUCOSAL |
| Active Ingredient Strength | 1600 |
| Active Ingredient Units | ug/1 |
| Substance Name | FENTANYL CITRATE |
| Labeler Name | Cephalon, LLC |
| Pharmaceutical Class | Full Opioid Agonists [MoA], Opioid Agonist [EPC] |
| DEA Schedule | CII |
| Marketing Category | NDA |
| Application Number | NDA020747 |
| Listing Certified Through | 2023-12-31 |
Package
NDC 63459-0516-30 (63459051630)
| NDC Package Code | 63459-516-30 |
|---|---|
| Billing NDC | 63459051630 |
| Package | 30 BLISTER PACK in 1 CARTON (63459-516-30) / 1 LOZENGE in 1 BLISTER PACK (63459-516-01) |
| Marketing Start Date | 1999-01-20 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |