fentanyl citrate

Generic: fentanyl citrate

Labeler: teva pharmaceuticals usa, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA AUTHORIZED GENERIC Inactive Finished

Drug Facts

Product Profile

Brand Name fentanyl citrate
Generic Name fentanyl citrate
Labeler teva pharmaceuticals usa, inc.
Dosage Form LOZENGE
Routes
ORAL TRANSMUCOSAL
Active Ingredients

fentanyl citrate 800 ug/1

Manufacturer
Teva Pharmaceuticals USA, Inc.

Identifiers & Regulatory

Product NDC 0093-7868
Product ID 0093-7868_4dbe9184-14cd-4666-aabf-1b7fece92337
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA AUTHORIZED GENERIC
Application Number NDA020747
DEA Schedule cii
Marketing Start 2015-12-08
Marketing End 2026-08-31

Pharmacologic Class

Classes
full opioid agonists [moa] opioid agonist [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 00937868
Hyphenated Format 0093-7868

Supplemental Identifiers

RxCUI
310293 310294 310295 310297 313992 313993
UNII
MUN5LYG46H

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name fentanyl citrate (source: ndc)
Generic Name fentanyl citrate (source: ndc)
Application Number NDA020747 (source: ndc)
Routes
ORAL TRANSMUCOSAL
source: ndc

Resolved Composition

Strengths
  • 800 ug/1
source: ndc
Packaging
  • 30 BLISTER PACK in 1 CARTON (0093-7868-65) / 1 LOZENGE in 1 BLISTER PACK (0093-7868-19)
source: ndc

Packages (1)

0093-7868-65 30 BLISTER PACK in 1 CARTON (0093-7868-65) / 1 LOZENGE in 1 BLISTER PACK (0093-7868-19)

Ingredients (1)

fentanyl citrate (800 ug/1)

Linked Drug Pages (1)

Fentanyl Citrate ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL", "TRANSMUCOSAL"], "spl_id": "4dbe9184-14cd-4666-aabf-1b7fece92337", "openfda": {"unii": ["MUN5LYG46H"], "rxcui": ["310293", "310294", "310295", "310297", "313992", "313993"], "spl_set_id": ["78221eab-66fd-4cd8-9c81-af52eb83671c"], "manufacturer_name": ["Teva Pharmaceuticals USA, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 BLISTER PACK in 1 CARTON (0093-7868-65)  / 1 LOZENGE in 1 BLISTER PACK (0093-7868-19)", "package_ndc": "0093-7868-65", "marketing_end_date": "20260831", "marketing_start_date": "20151208"}], "brand_name": "Fentanyl Citrate", "product_id": "0093-7868_4dbe9184-14cd-4666-aabf-1b7fece92337", "dosage_form": "LOZENGE", "pharm_class": ["Full Opioid Agonists [MoA]", "Opioid Agonist [EPC]"], "product_ndc": "0093-7868", "dea_schedule": "CII", "generic_name": "Fentanyl Citrate", "labeler_name": "Teva Pharmaceuticals USA, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Fentanyl Citrate", "active_ingredients": [{"name": "FENTANYL CITRATE", "strength": "800 ug/1"}], "application_number": "NDA020747", "marketing_category": "NDA AUTHORIZED GENERIC", "marketing_end_date": "20260831", "marketing_start_date": "20151208"}