FDA.reportPublic FDA data

Citanest Forte

Product NDC
66312-540
11-digit product format
663120540
Labeler code
66312
Product ID
66312-540_5bc16e4b-6878-839f-e053-2991aa0abf4a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
prilocaine hydrochloride and epinephrine bitartrate
Dosage form
INJECTION, SOLUTION
Route
SUBMUCOSAL
Labeler
Dentsply Pharmaceutical Inc.
Application
NDA021383
Marketing category
NDA
Marketing start
1965-11-18
Marketing end
0000-00-00
Substance
PRILOCAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE
Active strength
40 mg/mL; mg/mL
Pharmacologic classes
Amide Local Anesthetic [EPC],Amides [CS],Local Anesthesia [PE],Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [CS]
NDC exclude flag
No
Listing certified through
2019-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct66312-540DDiscontinued by firm2026-07-31
excluded packagepackage66312-54066312-540-14DDiscontinued by firm2026-07-31
excluded packagepackage66312-54066312-540-16DDiscontinued by firm2026-07-31

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N021383-001CITANEST FORTE DENTALEPINEPHRINE BITARTRATE; PRILOCAINE HYDROCHLORIDE0.005MG/ML;4%INJECTABLE / INJECTIONAPRLD, RS, Approved before 1982

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
N021383-001AP

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06N021383-001CITANEST FORTE DENTAL0.005MG/ML;4%INJECTABLE / INJECTIONAPRLD, RS, Approved before 1982a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06N021383-001AP1a50c72e98297…

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
66312-540-142024-12-20C16284748780-19d75b9d0-4225-f424-e053-dadaa90a57ceCitanest ® Forte (prilocaine and epinephrine bitartrate injection, solution)
66312-540-162024-12-20C16284748780-19d75b9d0-4225-f424-e053-dadaa90a57ceCitanest ® Forte (prilocaine and epinephrine bitartrate injection, solution)
66312-540-142020-01-31C16284748780-19d75b9d0-4225-f424-e053-dadaa90a57ceCitanest ® Forte (prilocaine and epinephrine bitartrate injection, solution)
66312-540-162020-01-31C16284748780-19d75b9d0-4225-f424-e053-dadaa90a57ceCitanest ® Forte (prilocaine and epinephrine bitartrate injection, solution)

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
66312-540-16ML - Milliliter66312-54048176d4e-6822-4e15-b883-220e8e62bebc12014-11-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
epinephrine bitartrateACTIVE INGREDIENT30Q7KI53AKCITANEST FORTE (PRILOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [DENTSPLY PHARMACEUTICAL INC.]7
prilocaine hydrochlorideACTIVE INGREDIENTMJW015BAPHCITANEST FORTE (PRILOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [DENTSPLY PHARMACEUTICAL INC.]7
epinephrineACTIVE MOIETYYKH834O4BHCITANEST FORTE (PRILOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [DENTSPLY PHARMACEUTICAL INC.]7
prilocaineACTIVE MOIETY046O35D44RCITANEST FORTE (PRILOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [DENTSPLY PHARMACEUTICAL INC.]7
Citric Acid MonohydrateINACTIVE INGREDIENT2968PHW8QPCITANEST FORTE (PRILOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [DENTSPLY PHARMACEUTICAL INC.]7
sodium metabisulfiteINACTIVE INGREDIENT4VON5FNS3CCITANEST FORTE (PRILOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [DENTSPLY PHARMACEUTICAL INC.]7
WaterINACTIVE INGREDIENT059QF0KO0RCITANEST FORTE (PRILOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [DENTSPLY PHARMACEUTICAL INC.]7