Home NDC 66312-580 Citanest Forte DENTAL
Product NDC 66312-580
11-digit product format 663120580
Labeler code 66312
Product ID 66312-580_9ea4e9ed-3979-422b-b516-6b3c32459a62
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name prilocaine hcl and epinephrine
Dosage form INJECTION, SOLUTION
Route SUBMUCOSAL
Labeler Dentsply Pharmaceutical Inc.
Application ANDA078959
Marketing category ANDA
Marketing start 2017-12-04
Substance EPINEPHRINE BITARTRATE; PRILOCAINE HYDROCHLORIDE
Active strength .005; 40 mg/mL; mg/mL
Pharmacologic 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]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes 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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A078959-001 PRILOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE EPINEPHRINE BITARTRATE; PRILOCAINE HYDROCHLORIDE 0.005MG/ML;4% INJECTABLE / INJECTION AP 2011-08-30
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A078959-001 AP
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.
Product history page 1 of 2 · 41 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 A078959-001 PRILOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE 0.005MG/ML;4% INJECTABLE / INJECTION AP 2011-08-30 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078959-001 PRILOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE 0.005MG/ML;4% INJECTABLE / INJECTION AP 2011-08-30 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A078959-001 PRILOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE 0.005MG/ML;4% INJECTABLE / INJECTION AP 2011-08-30 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078959-001 PRILOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE 0.005MG/ML;4% INJECTABLE / INJECTION AP 2011-08-30 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078959-001 PRILOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE 0.005MG/ML;4% INJECTABLE / INJECTION AP 2011-08-30 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078959-001 PRILOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE 0.005MG/ML;4% INJECTABLE / INJECTION AP 2011-08-30 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078959-001 PRILOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE 0.005MG/ML;4% INJECTABLE / INJECTION AP 2011-08-30 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078959-001 PRILOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE 0.005MG/ML;4% INJECTABLE / INJECTION AP 2011-08-30 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078959-001 PRILOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE 0.005MG/ML;4% INJECTABLE / INJECTION AP 2011-08-30 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A078959-001 PRILOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE 0.005MG/ML;4% INJECTABLE / INJECTION AP 2011-08-30 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A078959-001 PRILOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE 0.005MG/ML;4% INJECTABLE / INJECTION AP 2011-08-30 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A078959-001 PRILOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE 0.005MG/ML;4% INJECTABLE / INJECTION AP 2011-08-30 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A078959-001 PRILOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE 0.005MG/ML;4% INJECTABLE / INJECTION AP 2011-08-30 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A078959-001 PRILOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE 0.005MG/ML;4% INJECTABLE / INJECTION AP 2011-08-30 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A078959-001 PRILOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE 0.005MG/ML;4% INJECTABLE / INJECTION AP 2011-08-30 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A078959-001 PRILOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE 0.005MG/ML;4% INJECTABLE / INJECTION AP 2011-08-30 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A078959-001 PRILOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE 0.005MG/ML;4% INJECTABLE / INJECTION AP 2011-08-30 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A078959-001 PRILOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE 0.005MG/ML;4% INJECTABLE / INJECTION AP 2011-08-30 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A078959-001 PRILOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE 0.005MG/ML;4% INJECTABLE / INJECTION AP 2011-08-30 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A078959-001 PRILOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE 0.005MG/ML;4% INJECTABLE / INJECTION AP 2011-08-30 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A078959-001 PRILOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE 0.005MG/ML;4% INJECTABLE / INJECTION AP 2011-08-30 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A078959-001 PRILOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE 0.005MG/ML;4% INJECTABLE / INJECTION AP 2011-08-30 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A078959-001 PRILOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE 0.005MG/ML;4% INJECTABLE / INJECTION AP 2011-08-30 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A078959-001 PRILOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE 0.005MG/ML;4% INJECTABLE / INJECTION AP 2011-08-30 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A078959-001 PRILOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE 0.005MG/ML;4% INJECTABLE / INJECTION AP 2011-08-30 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A078959-001 PRILOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE 0.005MG/ML;4% INJECTABLE / INJECTION AP 2011-08-30 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A078959-001 PRILOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE 0.005MG/ML;4% INJECTABLE / INJECTION AP 2011-08-30 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A078959-001 PRILOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE 0.005MG/ML;4% INJECTABLE / INJECTION AP 2011-08-30 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A078959-001 PRILOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE 0.005MG/ML;4% INJECTABLE / INJECTION AP 2011-08-30 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A078959-001 PRILOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE 0.005MG/ML;4% INJECTABLE / INJECTION AP 2011-08-30 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A078959-001 PRILOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE 0.005MG/ML;4% INJECTABLE / INJECTION AP 2011-08-30 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A078959-001 PRILOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE 0.005MG/ML;4% INJECTABLE / INJECTION AP 2011-08-30 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A078959-001 PRILOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE 0.005MG/ML;4% INJECTABLE / INJECTION AP 2011-08-30 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A078959-001 PRILOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE 0.005MG/ML;4% INJECTABLE / INJECTION AP 2011-08-30 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A078959-001 PRILOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE 0.005MG/ML;4% INJECTABLE / INJECTION AP 2011-08-30 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A078959-001 PRILOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE 0.005MG/ML;4% INJECTABLE / INJECTION AP 2011-08-30 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A078959-001 PRILOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE 0.005MG/ML;4% INJECTABLE / INJECTION AP 2011-08-30 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A078959-001 PRILOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE 0.005MG/ML;4% INJECTABLE / INJECTION AP 2011-08-30 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A078959-001 PRILOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE 0.005MG/ML;4% INJECTABLE / INJECTION AP 2011-08-30 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A078959-001 PRILOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE 0.005MG/ML;4% INJECTABLE / INJECTION AP 2011-08-30 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Citanest Forte DENTAL
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength PRILOCAINE HYDROCHLORIDE .005 mg/mL EPINEPHRINE BITARTRATE 40 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination MJW015BAPH Internal UNII lookup 30Q7KI53AK Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1596950 Internal RxNorm lookup 1993224 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 66312-580-16 Citanest Forte DENTAL 50 in 1 CARTON INJECTION, SOLUTION 50 7 66312-580-16 Citanest Forte DENTAL 1.8 mL in 1 CARTRIDGE INJECTION, SOLUTION 1.8 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 66312-580 CITANEST FORTE DENTAL (PRILOCAINE HCL AND EPINEPHRINE) INJECTION, SOLUTION [DENTSPLY PHARMACEUTICAL INC.] 7 Current NDC, Legacy NDC, 2 package rows 20240302_60c8710b-ae55-4fdf-e053-2991aa0adc75.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 2 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 66312-580-16 66312058016 50 CARTRIDGE in 1 CARTON (66312-580-16) / 1.8 mL in 1 CARTRIDGE 50 cartridge 2017-12-04 0000-00-00 No No Current