Home NDC 52120-100 Ultacan Forte
Product NDC 52120-100
11-digit product format 521200100
Labeler code 52120
Product ID 52120-100_85dfc4ff-e676-4dac-9dd8-63c15af9842c
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name articaine hydrochloride, epinephrine bitartrate
Dosage form INJECTION, SOLUTION
Route SUBMUCOSAL
Labeler HANSAmed, Inc.
Application ANDA201750
Marketing category ANDA
Marketing start 2017-07-11
Marketing end 0000-00-00
Substance ARTICAINE 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 E
Listing certified through 2018-12-31
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 2 · 88 matching rows.
View current auxiliary records. · View the auxiliary file history.
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 A201750-001 ULTACAN FORTE ARTICAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE 4%;EQ 0.017MG BASE/1.7ML (4%; EQ 0.01MG BASE/ML) INJECTABLE / INJECTION 2017-07-11
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 · 43 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 2026-09-14 22:38:34 2026-08 A201750-001 ULTACAN FORTE 4%;EQ 0.017MG BASE/1.7ML (4%; EQ 0.01MG BASE/ML) INJECTABLE / INJECTION 2017-07-11 84e616aacf4f…2026-08-18 06:07:40 2026-07 A201750-001 ULTACAN FORTE 4%;EQ 0.017MG BASE/1.7ML (4%; EQ 0.01MG BASE/ML) INJECTABLE / INJECTION 2017-07-11 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A201750-001 ULTACAN FORTE 4%;EQ 0.017MG BASE/1.7ML (4%; EQ 0.01MG BASE/ML) INJECTABLE / INJECTION 2017-07-11 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A201750-001 ULTACAN FORTE 4%;EQ 0.017MG BASE/1.7ML (4%; EQ 0.01MG BASE/ML) INJECTABLE / INJECTION 2017-07-11 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A201750-001 ULTACAN FORTE 4%;EQ 0.017MG BASE/1.7ML (4%; EQ 0.01MG BASE/ML) INJECTABLE / INJECTION 2017-07-11 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A201750-001 ULTACAN FORTE 4%;EQ 0.017MG BASE/1.7ML (4%; EQ 0.01MG BASE/ML) INJECTABLE / INJECTION 2017-07-11 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A201750-001 ULTACAN FORTE 4%;EQ 0.017MG BASE/1.7ML (4%; EQ 0.01MG BASE/ML) INJECTABLE / INJECTION 2017-07-11 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A201750-001 ULTACAN FORTE 4%;EQ 0.017MG BASE/1.7ML (4%; EQ 0.01MG BASE/ML) INJECTABLE / INJECTION 2017-07-11 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A201750-001 ULTACAN FORTE 4%;EQ 0.017MG BASE/1.7ML (4%; EQ 0.01MG BASE/ML) INJECTABLE / INJECTION 2017-07-11 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A201750-001 ULTACAN FORTE 4%;EQ 0.017MG BASE/1.7ML (4%; EQ 0.01MG BASE/ML) INJECTABLE / INJECTION 2017-07-11 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A201750-001 ULTACAN FORTE 4%;EQ 0.017MG BASE/1.7ML (4%; EQ 0.01MG BASE/ML) INJECTABLE / INJECTION 2017-07-11 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A201750-001 ULTACAN FORTE 4%;EQ 0.017MG BASE/1.7ML (4%; EQ 0.01MG BASE/ML) INJECTABLE / INJECTION 2017-07-11 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A201750-001 ULTACAN FORTE 4%;EQ 0.017MG BASE/1.7ML (4%; EQ 0.01MG BASE/ML) INJECTABLE / INJECTION 2017-07-11 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A201750-001 ULTACAN FORTE 4%;EQ 0.017MG BASE/1.7ML (4%; EQ 0.01MG BASE/ML) INJECTABLE / INJECTION 2017-07-11 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A201750-001 ULTACAN FORTE 4%;EQ 0.017MG BASE/1.7ML (4%; EQ 0.01MG BASE/ML) INJECTABLE / INJECTION 2017-07-11 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A201750-001 ULTACAN FORTE 4%;EQ 0.017MG BASE/1.7ML (4%; EQ 0.01MG BASE/ML) INJECTABLE / INJECTION 2017-07-11 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A201750-001 ULTACAN FORTE 4%;EQ 0.017MG BASE/1.7ML (4%; EQ 0.01MG BASE/ML) INJECTABLE / INJECTION 2017-07-11 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A201750-001 ULTACAN FORTE 4%;EQ 0.017MG BASE/1.7ML (4%; EQ 0.01MG BASE/ML) INJECTABLE / INJECTION 2017-07-11 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A201750-001 ULTACAN FORTE 4%;EQ 0.017MG BASE/1.7ML (4%; EQ 0.01MG BASE/ML) INJECTABLE / INJECTION 2017-07-11 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A201750-001 ULTACAN FORTE 4%;EQ 0.017MG BASE/1.7ML (4%; EQ 0.01MG BASE/ML) INJECTABLE / INJECTION AP 2017-07-11 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A201750-001 ULTACAN FORTE 4%;EQ 0.017MG BASE/1.7ML (4%; EQ 0.01MG BASE/ML) INJECTABLE / INJECTION 2017-07-11 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A201750-001 ULTACAN FORTE 4%;EQ 0.017MG BASE/1.7ML (4%; EQ 0.01MG BASE/ML) INJECTABLE / INJECTION 2017-07-11 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A201750-001 ULTACAN FORTE 4%;EQ 0.017MG BASE/1.7ML (4%; EQ 0.01MG BASE/ML) INJECTABLE / INJECTION 2017-07-11 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A201750-001 ULTACAN FORTE 4%;EQ 0.017MG BASE/1.7ML (4%; EQ 0.01MG BASE/ML) INJECTABLE / INJECTION 2017-07-11 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A201750-001 ULTACAN FORTE 4%;EQ 0.017MG BASE/1.7ML (4%; EQ 0.01MG BASE/ML) INJECTABLE / INJECTION 2017-07-11 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A201750-001 ULTACAN FORTE 4%;EQ 0.017MG BASE/1.7ML (4%; EQ 0.01MG BASE/ML) INJECTABLE / INJECTION 2017-07-11 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A201750-001 ULTACAN FORTE 4%;EQ 0.017MG BASE/1.7ML (4%; EQ 0.01MG BASE/ML) INJECTABLE / INJECTION AP 2017-07-11 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A201750-001 ULTACAN FORTE 4%;EQ 0.017MG BASE/1.7ML (4%; EQ 0.01MG BASE/ML) INJECTABLE / INJECTION AP 2017-07-11 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A201750-001 ULTACAN FORTE 4%;EQ 0.017MG BASE/1.7ML (4%; EQ 0.01MG BASE/ML) INJECTABLE / INJECTION AP 2017-07-11 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A201750-001 ULTACAN FORTE 4%;EQ 0.017MG BASE/1.7ML (4%; EQ 0.01MG BASE/ML) INJECTABLE / INJECTION 2017-07-11 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A201750-001 ULTACAN FORTE 4%;EQ 0.017MG BASE/1.7ML (4%; EQ 0.01MG BASE/ML) INJECTABLE / INJECTION 2017-07-11 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A201750-001 ULTACAN FORTE 4%;EQ 0.017MG BASE/1.7ML (4%; EQ 0.01MG BASE/ML) INJECTABLE / INJECTION 2017-07-11 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A201750-001 ULTACAN FORTE 4%;EQ 0.017MG BASE/1.7ML (4%; EQ 0.01MG BASE/ML) INJECTABLE / INJECTION 2017-07-11 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A201750-001 ULTACAN FORTE 4%;EQ 0.017MG BASE/1.7ML (4%; EQ 0.01MG BASE/ML) INJECTABLE / INJECTION 2017-07-11 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A201750-001 ULTACAN FORTE 4%;EQ 0.017MG BASE/1.7ML (4%; EQ 0.01MG BASE/ML) INJECTABLE / INJECTION 2017-07-11 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A201750-001 ULTACAN FORTE 4%;EQ 0.017MG BASE/1.7ML (4%; EQ 0.01MG BASE/ML) INJECTABLE / INJECTION 2017-07-11 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A201750-001 ULTACAN FORTE 4%;EQ 0.017MG BASE/1.7ML (4%; EQ 0.01MG BASE/ML) INJECTABLE / INJECTION 2017-07-11 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A201750-001 ULTACAN FORTE 4%;EQ 0.017MG BASE/1.7ML (4%; EQ 0.01MG BASE/ML) INJECTABLE / INJECTION 2017-07-11 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A201750-001 ULTACAN FORTE 4%;EQ 0.017MG BASE/1.7ML (4%; EQ 0.01MG BASE/ML) INJECTABLE / INJECTION 2017-07-11 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A201750-001 ULTACAN FORTE 4%;EQ 0.017MG BASE/1.7ML (4%; EQ 0.01MG BASE/ML) INJECTABLE / INJECTION 2017-07-11 f41ea6bd6efb…
Observed Orange Book normalized TE history# Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# NDC, Effective, Action table NDC Effective Action Document Indexing SPL Related label 52120-100-01 2020-01-31 C162847 48780-1 9d75b9d0-085c-f424-e053-dadaa90a57ce These highlights do not include all the information needed to use Ultacan® and Ultacan® forte safely and effectively. See full prescribing information for Ultacan® and Ultacan® forte. Ultacan® and Ultacan® forte (Articaine HCl 4% and epinephrine Injection, USP); Intraoral Submucosal Injection Articaine hydrochloride 4% and epinephrine 1:200,000 Articaine hydrochloride 4% and epinephrine 1:100,000 Initial U.S. Approval: 2000 52120-100-05 2020-01-31 C162847 48780-1 9d75b9d0-085c-f424-e053-dadaa90a57ce These highlights do not include all the information needed to use Ultacan® and Ultacan® forte safely and effectively. See full prescribing information for Ultacan® and Ultacan® forte. Ultacan® and Ultacan® forte (Articaine HCl 4% and epinephrine Injection, USP); Intraoral Submucosal Injection Articaine hydrochloride 4% and epinephrine 1:200,000 Articaine hydrochloride 4% and epinephrine 1:100,000 Initial U.S. Approval: 2000 52120-100-10 2020-01-31 C162847 48780-1 9d75b9d0-085c-f424-e053-dadaa90a57ce These highlights do not include all the information needed to use Ultacan® and Ultacan® forte safely and effectively. See full prescribing information for Ultacan® and Ultacan® forte. Ultacan® and Ultacan® forte (Articaine HCl 4% and epinephrine Injection, USP); Intraoral Submucosal Injection Articaine hydrochloride 4% and epinephrine 1:200,000 Articaine hydrochloride 4% and epinephrine 1:100,000 Initial U.S. Approval: 2000
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 52120-100-00 Ultacan Forte 1.7 mL in 1 CARTRIDGE INJECTION, SOLUTION 1.7 1 52120-100-01 Ultacan Forte 10 in 1 BOX INJECTION, SOLUTION 10 1 52120-100-05 Ultacan Forte 50 in 1 BOX INJECTION, SOLUTION 50 1 52120-100-10 Ultacan Forte 100 in 1 BOX INJECTION, SOLUTION 100 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 52120-100 ULTACAN (ARTICAINE HYDROCHLORIDE, EPINEPHRINE BITARTRATE) INJECTION, SOLUTION ULTACAN FORTE (ARTICAINE HYDROCHLORIDE, EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [HANSAMED, INC.] 1 Legacy NDC, 4 package rows 20170720_e005e3da-142d-4eba-a0c0-35e05b234130.zip
DailyMed RxNorm Mappings# RxCUI, RxNorm string, TTY table RxCUI RxNorm string TTY DailyMed SPL version 1928862 articaine hydrochloride 40 MG / EPINEPHrine bitartrate 1:100,000 in 1.7 ML Cartridge PSN e005e3da-142d-4eba-a0c0-35e05b234130 1 1928853 articaine hydrochloride 40 MG / EPINEPHrine bitartrate 1:200,000 in 1.7 ML Cartridge PSN e005e3da-142d-4eba-a0c0-35e05b234130 1 1928858 Ultacan 40 MG / 1:200,000 in 1.7 ML Cartridge PSN e005e3da-142d-4eba-a0c0-35e05b234130 1 1928864 Ultacan forte 40 MG / 1:100,000 in 1.7 ML Cartridge PSN e005e3da-142d-4eba-a0c0-35e05b234130 1 1928858 1.7 ML articaine hydrochloride 40 MG/ML / epinephrine bitartrate 0.009 MG/ML Cartridge [Ultacan] SBD e005e3da-142d-4eba-a0c0-35e05b234130 1 1928864 1.7 ML articaine hydrochloride 40 MG/ML / epinephrine bitartrate 0.018 MG/ML Cartridge [Ultacan] SBD e005e3da-142d-4eba-a0c0-35e05b234130 1 1928853 1.7 ML articaine hydrochloride 40 MG/ML / epinephrine bitartrate 0.009 MG/ML Cartridge SCD e005e3da-142d-4eba-a0c0-35e05b234130 1 1928862 1.7 ML articaine hydrochloride 40 MG/ML / epinephrine bitartrate 0.018 MG/ML Cartridge SCD e005e3da-142d-4eba-a0c0-35e05b234130 1 1928853 articaine hydrochloride 40 MG / epinephrine bitartrate 0.009 MG per 1.7 ML Cartridge SY e005e3da-142d-4eba-a0c0-35e05b234130 1 1928862 articaine hydrochloride 40 MG / epinephrine bitartrate 0.018 MG per 1.7 ML Cartridge SY e005e3da-142d-4eba-a0c0-35e05b234130 1 1928862 articaine hydrochloride 40 MG / epinephrine bitartrate 1:100,000 per 1.7 ML Cartridge SY e005e3da-142d-4eba-a0c0-35e05b234130 1 1928853 articaine hydrochloride 40 MG / epinephrine bitartrate 1:200,000 per 1.7 ML Cartridge SY e005e3da-142d-4eba-a0c0-35e05b234130 1 1928858 Ultacan 40 MG / 0.009 MG per 1.7 ML Cartridge SY e005e3da-142d-4eba-a0c0-35e05b234130 1 1928864 Ultacan 40 MG / 0.018 MG per 1.7 ML Cartridge SY e005e3da-142d-4eba-a0c0-35e05b234130 1 1928864 Ultacan 40 MG / 1:100,000 per 1.7 ML Cartridge SY e005e3da-142d-4eba-a0c0-35e05b234130 1 1928858 Ultacan 40 MG / 1:200,000 per 1.7 ML Cartridge SY e005e3da-142d-4eba-a0c0-35e05b234130 1
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Status 52120-100-00 52120010000 1.7 mL in 1 CARTRIDGE 1.7 ml Historical 52120-100-01 52120010001 10 in 1 BOX Historical 52120-100-05 52120010005 50 in 1 BOX Historical 52120-100-10 52120010010 100 in 1 BOX Historical