citanest forte dental

Generic: prilocaine hcl and epinephrine

Labeler: dentsply pharmaceutical inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name citanest forte dental
Generic Name prilocaine hcl and epinephrine
Labeler dentsply pharmaceutical inc.
Dosage Form INJECTION, SOLUTION
Routes
SUBMUCOSAL
Active Ingredients

epinephrine bitartrate .005 mg/mL, prilocaine hydrochloride 40 mg/mL

Manufacturer
Dentsply Pharmaceutical Inc.

Identifiers & Regulatory

Product NDC 66312-580
Product ID 66312-580_9ea4e9ed-3979-422b-b516-6b3c32459a62
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078959
Listing Expiration 2026-12-31
Marketing Start 2017-12-04

Pharmacologic Class

Classes
adrenergic alpha-agonists [moa] adrenergic beta-agonists [moa] amide local anesthetic [epc] amides [cs] catecholamine [epc] catecholamines [cs] local anesthesia [pe] alpha-adrenergic agonist [epc] beta-adrenergic agonist [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 66312580
Hyphenated Format 66312-580

Supplemental Identifiers

RxCUI
1596950 1993224
UNII
30Q7KI53AK MJW015BAPH

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 citanest forte dental (source: ndc)
Generic Name prilocaine hcl and epinephrine (source: ndc)
Application Number ANDA078959 (source: ndc)
Routes
SUBMUCOSAL
source: ndc

Resolved Composition

Strengths
  • .005 mg/mL
  • 40 mg/mL
source: ndc
Packaging
  • 50 CARTRIDGE in 1 CARTON (66312-580-16) / 1.8 mL in 1 CARTRIDGE
source: ndc

Packages (1)

66312-580-16 50 CARTRIDGE in 1 CARTON (66312-580-16) / 1.8 mL in 1 CARTRIDGE

Ingredients (2)

epinephrine bitartrate (.005 mg/mL) prilocaine hydrochloride (40 mg/mL)

Linked Drug Pages (1)

Citanest Forte DENTAL ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["SUBMUCOSAL"], "spl_id": "9ea4e9ed-3979-422b-b516-6b3c32459a62", "openfda": {"unii": ["30Q7KI53AK", "MJW015BAPH"], "rxcui": ["1596950", "1993224"], "spl_set_id": ["60c8710b-ae55-4fdf-e053-2991aa0adc75"], "manufacturer_name": ["Dentsply Pharmaceutical Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "50 CARTRIDGE in 1 CARTON (66312-580-16)  / 1.8 mL in 1 CARTRIDGE", "package_ndc": "66312-580-16", "marketing_start_date": "20171204"}], "brand_name": "Citanest Forte DENTAL", "product_id": "66312-580_9ea4e9ed-3979-422b-b516-6b3c32459a62", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Adrenergic alpha-Agonists [MoA]", "Adrenergic beta-Agonists [MoA]", "Amide Local Anesthetic [EPC]", "Amides [CS]", "Catecholamine [EPC]", "Catecholamines [CS]", "Local Anesthesia [PE]", "alpha-Adrenergic Agonist [EPC]", "beta-Adrenergic Agonist [EPC]"], "product_ndc": "66312-580", "generic_name": "prilocaine hcl and epinephrine", "labeler_name": "Dentsply Pharmaceutical Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Citanest Forte DENTAL", "active_ingredients": [{"name": "EPINEPHRINE BITARTRATE", "strength": ".005 mg/mL"}, {"name": "PRILOCAINE HYDROCHLORIDE", "strength": "40 mg/mL"}], "application_number": "ANDA078959", "marketing_category": "ANDA", "marketing_start_date": "20171204", "listing_expiration_date": "20261231"}