citanest plain

Generic: prilocaine hydrochloride

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

Drug Facts

Product Profile

Brand Name citanest plain
Generic Name prilocaine hydrochloride
Labeler dentsply pharmaceutical inc.
Dosage Form INJECTION, SOLUTION
Routes
SUBMUCOSAL
Active Ingredients

prilocaine hydrochloride 40 mg/mL

Manufacturer
Dentsply Pharmaceutical Inc.

Identifiers & Regulatory

Product NDC 66312-630
Product ID 66312-630_14eaeca2-d602-48eb-a384-eee02a9a1b04
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA079235
Listing Expiration 2026-12-31
Marketing Start 1965-11-18

Pharmacologic Class

Classes
amide local anesthetic [epc] amides [cs] local anesthesia [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 66312630
Hyphenated Format 66312-630

Supplemental Identifiers

RxCUI
1012706 1595048
UNII
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 plain (source: ndc)
Generic Name prilocaine hydrochloride (source: ndc)
Application Number ANDA079235 (source: ndc)
Routes
SUBMUCOSAL
source: ndc

Resolved Composition

Strengths
  • 40 mg/mL
source: ndc
Packaging
  • 50 CARTRIDGE in 1 CARTON (66312-630-14) / 1.8 mL in 1 CARTRIDGE
source: ndc

Packages (1)

66312-630-14 50 CARTRIDGE in 1 CARTON (66312-630-14) / 1.8 mL in 1 CARTRIDGE

Ingredients (1)

prilocaine hydrochloride (40 mg/mL)

Linked Drug Pages (1)

Citanest Plain ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["SUBMUCOSAL"], "spl_id": "14eaeca2-d602-48eb-a384-eee02a9a1b04", "openfda": {"unii": ["MJW015BAPH"], "rxcui": ["1012706", "1595048"], "spl_set_id": ["db23a56f-1e41-4843-9220-1b2e3059db41"], "manufacturer_name": ["Dentsply Pharmaceutical Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "50 CARTRIDGE in 1 CARTON (66312-630-14)  / 1.8 mL in 1 CARTRIDGE", "package_ndc": "66312-630-14", "marketing_start_date": "19651118"}], "brand_name": "Citanest Plain", "product_id": "66312-630_14eaeca2-d602-48eb-a384-eee02a9a1b04", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Amide Local Anesthetic [EPC]", "Amides [CS]", "Local Anesthesia [PE]"], "product_ndc": "66312-630", "generic_name": "prilocaine hydrochloride", "labeler_name": "Dentsply Pharmaceutical Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Citanest Plain", "active_ingredients": [{"name": "PRILOCAINE HYDROCHLORIDE", "strength": "40 mg/mL"}], "application_number": "ANDA079235", "marketing_category": "ANDA", "marketing_start_date": "19651118", "listing_expiration_date": "20261231"}