Home NDC 66312-630 Citanest Plain
Product NDC 66312-630
11-digit product format 663120630
Labeler code 66312
Product ID 66312-630_14eaeca2-d602-48eb-a384-eee02a9a1b04
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name prilocaine hydrochloride
Dosage form INJECTION, SOLUTION
Route SUBMUCOSAL
Labeler Dentsply Pharmaceutical Inc.
Application ANDA079235
Marketing category ANDA
Marketing start 1965-11-18
Substance PRILOCAINE HYDROCHLORIDE
Active strength 40 mg/mL
Pharmacologic classes Amide Local Anesthetic [EPC], Amides [CS], Local Anesthesia [PE]
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 A079235-001 PRILOCAINE HYDROCHLORIDE PRILOCAINE HYDROCHLORIDE 4% INJECTABLE / INJECTION RS 2010-09-29
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 A079235-001 PRILOCAINE HYDROCHLORIDE 4% INJECTABLE / INJECTION RS 2010-09-29 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A079235-001 PRILOCAINE HYDROCHLORIDE 4% INJECTABLE / INJECTION RS 2010-09-29 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A079235-001 PRILOCAINE HYDROCHLORIDE 4% INJECTABLE / INJECTION RS 2010-09-29 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A079235-001 PRILOCAINE HYDROCHLORIDE 4% INJECTABLE / INJECTION RS 2010-09-29 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A079235-001 PRILOCAINE HYDROCHLORIDE 4% INJECTABLE / INJECTION RS 2010-09-29 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A079235-001 PRILOCAINE HYDROCHLORIDE 4% INJECTABLE / INJECTION RS 2010-09-29 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A079235-001 PRILOCAINE HYDROCHLORIDE 4% INJECTABLE / INJECTION RS 2010-09-29 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A079235-001 PRILOCAINE HYDROCHLORIDE 4% INJECTABLE / INJECTION RS 2010-09-29 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A079235-001 PRILOCAINE HYDROCHLORIDE 4% INJECTABLE / INJECTION RS 2010-09-29 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A079235-001 PRILOCAINE HYDROCHLORIDE 4% INJECTABLE / INJECTION RS 2010-09-29 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A079235-001 PRILOCAINE HYDROCHLORIDE 4% INJECTABLE / INJECTION RS 2010-09-29 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A079235-001 PRILOCAINE HYDROCHLORIDE 4% INJECTABLE / INJECTION RS 2010-09-29 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A079235-001 PRILOCAINE HYDROCHLORIDE 4% INJECTABLE / INJECTION RS 2010-09-29 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A079235-001 PRILOCAINE HYDROCHLORIDE 4% INJECTABLE / INJECTION RS 2010-09-29 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A079235-001 PRILOCAINE HYDROCHLORIDE 4% INJECTABLE / INJECTION RS 2010-09-29 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A079235-001 PRILOCAINE HYDROCHLORIDE 4% INJECTABLE / INJECTION RS 2010-09-29 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A079235-001 PRILOCAINE HYDROCHLORIDE 4% INJECTABLE / INJECTION RS 2010-09-29 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A079235-001 PRILOCAINE HYDROCHLORIDE 4% INJECTABLE / INJECTION RS 2010-09-29 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A079235-001 PRILOCAINE HYDROCHLORIDE 4% INJECTABLE / INJECTION RS 2010-09-29 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A079235-001 PRILOCAINE HYDROCHLORIDE 4% INJECTABLE / INJECTION RS 2010-09-29 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A079235-001 PRILOCAINE HYDROCHLORIDE 4% INJECTABLE / INJECTION RS 2010-09-29 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A079235-001 PRILOCAINE HYDROCHLORIDE 4% INJECTABLE / INJECTION RS 2010-09-29 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A079235-001 PRILOCAINE HYDROCHLORIDE 4% INJECTABLE / INJECTION RS 2010-09-29 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A079235-001 PRILOCAINE HYDROCHLORIDE 4% INJECTABLE / INJECTION RS 2010-09-29 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A079235-001 PRILOCAINE HYDROCHLORIDE 4% INJECTABLE / INJECTION RS 2010-09-29 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A079235-001 PRILOCAINE HYDROCHLORIDE 4% INJECTABLE / INJECTION RS 2010-09-29 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A079235-001 PRILOCAINE HYDROCHLORIDE 4% INJECTABLE / INJECTION RS 2010-09-29 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A079235-001 PRILOCAINE HYDROCHLORIDE 4% INJECTABLE / INJECTION RS 2010-09-29 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A079235-001 PRILOCAINE HYDROCHLORIDE 4% INJECTABLE / INJECTION RS 2010-09-29 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A079235-001 PRILOCAINE HYDROCHLORIDE 4% INJECTABLE / INJECTION RS 2010-09-29 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A079235-001 PRILOCAINE HYDROCHLORIDE 4% INJECTABLE / INJECTION RS 2010-09-29 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A079235-001 PRILOCAINE HYDROCHLORIDE 4% INJECTABLE / INJECTION RS 2010-09-29 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A079235-001 PRILOCAINE HYDROCHLORIDE 4% INJECTABLE / INJECTION RS 2010-09-29 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A079235-001 PRILOCAINE HYDROCHLORIDE 4% INJECTABLE / INJECTION RS 2010-09-29 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A079235-001 PRILOCAINE HYDROCHLORIDE 4% INJECTABLE / INJECTION RS 2010-09-29 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A079235-001 PRILOCAINE HYDROCHLORIDE 4% INJECTABLE / INJECTION RS 2010-09-29 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A079235-001 PRILOCAINE HYDROCHLORIDE 4% INJECTABLE / INJECTION RS 2010-09-29 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A079235-001 PRILOCAINE HYDROCHLORIDE 4% INJECTABLE / INJECTION RS 2010-09-29 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A079235-001 PRILOCAINE HYDROCHLORIDE 4% INJECTABLE / INJECTION RS 2010-09-29 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A079235-001 PRILOCAINE HYDROCHLORIDE 4% INJECTABLE / INJECTION RS 2010-09-29 cb3db0bc1861…
Additional Listing Data#
Finished product Yes
Brand name base Citanest Plain
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength PRILOCAINE HYDROCHLORIDE 40 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination MJW015BAPH Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1012706 Internal RxNorm lookup 1595048 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 66312-630-14 Citanest Plain 50 in 1 CARTON INJECTION, SOLUTION 50 8 66312-630-14 Citanest Plain 1.8 mL in 1 CARTRIDGE INJECTION, SOLUTION 1.8 8
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 66312-630 CITANEST PLAIN (PRILOCAINE HYDROCHLORIDE) INJECTION, SOLUTION [DENTSPLY PHARMACEUTICAL INC.] 8 Current NDC, Legacy NDC, 2 package rows 20211113_db23a56f-1e41-4843-9220-1b2e3059db41.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 · 1 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 66312-630-14 66312063014 50 CARTRIDGE in 1 CARTON (66312-630-14) / 1.8 mL in 1 CARTRIDGE 50 cartridge 1965-11-18 0000-00-00 No No Current