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NDC 63459-0541-28 FENTORA 100 ug/1 Details
FENTORA 100 ug/1
FENTORA is a BUCCAL; SUBLINGUAL TABLET in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Cephalon, LLC. The primary component is FENTANYL CITRATE.
Product Information
| NDC | 63459-0541 |
|---|---|
| Product ID | 63459-541_0241b137-cfa8-4101-b05b-da1938a22963 |
| Associated GPIs | 65100025100310 |
| GCN Sequence Number | 061492 |
| GCN Sequence Number Description | fentanyl citrate TABLET EFF 100 MCG BUCCAL |
| HIC3 | H3A |
| HIC3 Description | OPIOID ANALGESICS |
| GCN | 97280 |
| HICL Sequence Number | 001747 |
| HICL Sequence Number Description | FENTANYL CITRATE |
| Brand/Generic | Brand |
| Proprietary Name | FENTORA |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Fentanyl |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | TABLET |
| Route | BUCCAL; SUBLINGUAL |
| Active Ingredient Strength | 100 |
| 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 | NDA021947 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 63459-0541-28 (63459054128)
| NDC Package Code | 63459-541-28 |
|---|---|
| Billing NDC | 63459054128 |
| Package | 28 BLISTER PACK in 1 CARTON (63459-541-28) / 1 TABLET in 1 BLISTER PACK (63459-541-04) |
| Marketing Start Date | 2006-10-02 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |