Lidocaine Hydrochloride and Epinephrine Bitartrate

Product NDC: 42756-1030
11-digit product format: 427561030
Labeler code: 42756
Product ID: 42756-1030_6dc8dd56-839d-42a7-b818-b4983b9a1c32
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Lidocaine Hydrochloride and Epinephrine Bitartrate
Dosage form: INJECTION, SOLUTION
Route: SUBCUTANEOUS
Labeler: IQ Dental
Application: ANDA088390
Marketing category: ANDA
Marketing start: 2011-11-07
Marketing end: 0000-00-00
Substance: LIDOCAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE
Active strength: 20 mg/mL; mg/mL
Pharmacologic classes: Amide Local Anesthetic [EPC],Amides [CS],Antiarrhythmic [EPC],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: 2023-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	42756-1030		D	Discontinued by firm		2026-08-03
excluded package	package	42756-1030	42756-1030-5	D	Discontinued by firm		2026-08-03

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
A088390-001	LIGNOSPAN STANDARD	EPINEPHRINE BITARTRATE; LIDOCAINE HYDROCHLORIDE	EQ 0.01MG BASE/ML;2%	INJECTABLE / INJECTION		RLD, RS	1985-01-22

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	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A088390-001	LIGNOSPAN STANDARD	EQ 0.01MG BASE/ML;2%	INJECTABLE / INJECTION	RLD, RS	1985-01-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A088390-001	LIGNOSPAN STANDARD	EQ 0.01MG BASE/ML;2%	INJECTABLE / INJECTION	RLD, RS	1985-01-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A088390-001	LIGNOSPAN STANDARD	EQ 0.01MG BASE/ML;2%	INJECTABLE / INJECTION	RLD, RS	1985-01-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A088390-001	LIGNOSPAN STANDARD	EQ 0.01MG BASE/ML;2%	INJECTABLE / INJECTION	RLD, RS	1985-01-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A088390-001	LIGNOSPAN STANDARD	EQ 0.01MG BASE/ML;2%	INJECTABLE / INJECTION	RLD, RS	1985-01-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A088390-001	LIGNOSPAN STANDARD	EQ 0.01MG BASE/ML;2%	INJECTABLE / INJECTION	RLD, RS	1985-01-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A088390-001	LIGNOSPAN STANDARD	EQ 0.01MG BASE/ML;2%	INJECTABLE / INJECTION	RLD, RS	1985-01-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A088390-001	LIGNOSPAN STANDARD	EQ 0.01MG BASE/ML;2%	INJECTABLE / INJECTION	RLD, RS	1985-01-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A088390-001	LIGNOSPAN STANDARD	EQ 0.01MG BASE/ML;2%	INJECTABLE / INJECTION	RLD, RS	1985-01-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A088390-001	LIGNOSPAN STANDARD	EQ 0.01MG BASE/ML;2%	INJECTABLE / INJECTION	RLD, RS	1985-01-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A088390-001	LIGNOSPAN STANDARD	EQ 0.01MG BASE/ML;2%	INJECTABLE / INJECTION	RLD, RS	1985-01-22	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A088390-001	LIGNOSPAN STANDARD	EQ 0.01MG BASE/ML;2%	INJECTABLE / INJECTION	RLD, RS	1985-01-22	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A088390-001	LIGNOSPAN STANDARD	EQ 0.01MG BASE/ML;2%	INJECTABLE / INJECTION	RLD, RS	1985-01-22	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A088390-001	LIGNOSPAN STANDARD	EQ 0.01MG BASE/ML;2%	INJECTABLE / INJECTION	RLD, RS	1985-01-22	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A088390-001	LIGNOSPAN STANDARD	EQ 0.01MG BASE/ML;2%	INJECTABLE / INJECTION	RLD, RS	1985-01-22	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A088390-001	LIGNOSPAN STANDARD	EQ 0.01MG BASE/ML;2%	INJECTABLE / INJECTION	RLD, RS	1985-01-22	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A088390-001	LIGNOSPAN STANDARD	EQ 0.01MG BASE/ML;2%	INJECTABLE / INJECTION	RLD, RS	1985-01-22	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A088390-001	LIGNOSPAN STANDARD	EQ 0.01MG BASE/ML;2%	INJECTABLE / INJECTION	RS	1985-01-22	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A088390-001	LIGNOSPAN STANDARD	EQ 0.01MG BASE/ML;2%	INJECTABLE / INJECTION	RLD, RS	1985-01-22	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A088390-001	LIGNOSPAN STANDARD	EQ 0.01MG BASE/ML;2%	INJECTABLE / INJECTION	RS	1985-01-22	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A088390-001	LIGNOSPAN STANDARD	EQ 0.01MG BASE/ML;2%	INJECTABLE / INJECTION	RS	1985-01-22	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A088390-001	LIGNOSPAN STANDARD	EQ 0.01MG BASE/ML;2%	INJECTABLE / INJECTION	RS	1985-01-22	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A088390-001	LIGNOSPAN STANDARD	EQ 0.01MG BASE/ML;2%	INJECTABLE / INJECTION	RS	1985-01-22	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A088390-001	LIGNOSPAN STANDARD	EQ 0.01MG BASE/ML;2%	INJECTABLE / INJECTION	RS	1985-01-22	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A088390-001	LIGNOSPAN STANDARD	EQ 0.01MG BASE/ML;2%	INJECTABLE / INJECTION	RS	1985-01-22	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A088390-001	LIGNOSPAN STANDARD	EQ 0.01MG BASE/ML;2%	INJECTABLE / INJECTION	RS	1985-01-22	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A088390-001	LIGNOSPAN STANDARD	EQ 0.01MG BASE/ML;2%	INJECTABLE / INJECTION	RS	1985-01-22	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A088390-001	LIGNOSPAN STANDARD	EQ 0.01MG BASE/ML;2%	INJECTABLE / INJECTION	RLD, RS	1985-01-22	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A088390-001	LIGNOSPAN STANDARD	EQ 0.01MG BASE/ML;2%	INJECTABLE / INJECTION	RLD, RS	1985-01-22	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A088390-001	LIGNOSPAN STANDARD	EQ 0.01MG BASE/ML;2%	INJECTABLE / INJECTION	RLD, RS	1985-01-22	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A088390-001	LIGNOSPAN STANDARD	EQ 0.01MG BASE/ML;2%	INJECTABLE / INJECTION	RLD, RS	1985-01-22	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A088390-001	LIGNOSPAN STANDARD	EQ 0.01MG BASE/ML;2%	INJECTABLE / INJECTION	RLD, RS	1985-01-22	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A088390-001	LIGNOSPAN STANDARD	EQ 0.01MG BASE/ML;2%	INJECTABLE / INJECTION	RLD, RS	1985-01-22	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A088390-001	LIGNOSPAN STANDARD	EQ 0.01MG BASE/ML;2%	INJECTABLE / INJECTION	RLD, RS	1985-01-22	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A088390-001	LIGNOSPAN STANDARD	EQ 0.01MG BASE/ML;2%	INJECTABLE / INJECTION	RLD, RS	1985-01-22	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A088390-001	LIGNOSPAN STANDARD	EQ 0.01MG BASE/ML;2%	INJECTABLE / INJECTION	RLD, RS	1985-01-22	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A088390-001	LIGNOSPAN STANDARD	EQ 0.01MG BASE/ML;2%	INJECTABLE / INJECTION	RLD, RS	1985-01-22	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A088390-001	LIGNOSPAN STANDARD	EQ 0.01MG BASE/ML;2%	INJECTABLE / INJECTION	RLD, RS	1985-01-22	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A088390-001	LIGNOSPAN STANDARD	EQ 0.01MG BASE/ML;2%	INJECTABLE / INJECTION	RLD, RS	1985-01-22	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A088390-001	LIGNOSPAN STANDARD	EQ 0.01MG BASE/ML;2%	INJECTABLE / INJECTION	RLD, RS	1985-01-22	`cb3db0bc1861…`

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Epinephrine Bitartrate	ACTIVE INGREDIENT	30Q7KI53AK	LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE INJECTION, SOLUTION [IQ DENTAL]	1
Lidocaine Hydrochloride	ACTIVE INGREDIENT	V13007Z41A	LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE INJECTION, SOLUTION [IQ DENTAL]	1
Epinephrine	ACTIVE MOIETY	YKH834O4BH	LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE INJECTION, SOLUTION [IQ DENTAL]	1
Lidocaine	ACTIVE MOIETY	98PI200987	LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE INJECTION, SOLUTION [IQ DENTAL]	1
Edetate Disodium	INACTIVE INGREDIENT	7FLD91C86K	LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE INJECTION, SOLUTION [IQ DENTAL]	1
Potassium Metabisulfite	INACTIVE INGREDIENT	65OE787Q7W	LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE INJECTION, SOLUTION [IQ DENTAL]	1
Sodium Chloride	INACTIVE INGREDIENT	451W47IQ8X	LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE INJECTION, SOLUTION [IQ DENTAL]	1
Sodium Hydroxide	INACTIVE INGREDIENT	55X04QC32I	LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE INJECTION, SOLUTION [IQ DENTAL]	1
Water	INACTIVE INGREDIENT	059QF0KO0R	LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE INJECTION, SOLUTION [IQ DENTAL]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
42756-1030	LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE INJECTION, SOLUTION [IQ DENTAL]	4	Legacy NDC	20240209_b1b09a84-7978-4380-9c40-a4bf837be637.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 · 11 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Lidocaine	LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE	Benco Dental	c5cc87df-df3f-42b8-af84-5f2045d42084	2026-07-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 088390 application number: ANDA088390
LIDOCAINE	LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE	Patterson Dental	6506755f-c9f7-4286-9ba7-ac5d5745f5e4	2026-07-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 088390 application number: ANDA088390
Lidocaine	LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE	Darby Dental Supply, LLC	e5ed4c2a-e320-48cf-a2fd-61d48481c624	2026-07-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 088390 application number: ANDA088390
Lidocaine	LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE	Henry Schein Inc.	f8d90500-f797-4238-8dd2-b59cbcd89d12	2026-04-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 088390 application number: ANDA088390
Lidocaine	LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE	Novocol Pharmaceutical of Canada, Inc.	2005680a-8a23-4403-a618-e4ee74fa1121	2026-03-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 088390 application number: ANDA088390
Lignospan Standard	LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE	Septodont, Inc.	f902d2b4-28fc-41b1-a9f7-0d1a63c598aa	2025-03-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 088390 application number: ANDA088390
Lidocaine	LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE	Safco Dental Supply Co	6721c3ab-c37f-4504-aebc-0103c56ed567	2024-02-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 088390 application number: ANDA088390
LIDOCAINE	LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE	NDC, Inc.	937e9341-e604-4ca7-98e1-fc7c659d82e9	2024-02-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 088390 application number: ANDA088390
Lidocaine	LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE	The Atlanta Dental Supply Company DBA Advanced Dental Products	55030c51-250b-4fc2-ba3c-ac38dab7cc8e	2024-02-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 088390 application number: ANDA088390
Lidocaine	LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE	Septodont, Inc.	864e511b-cc50-4ed9-b122-8e1a93457332	2024-02-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 088390 application number: ANDA088390
Xylocaine	LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE	Dentsply Pharmaceutical	14b55cf9-f7cd-4bb4-a7c5-aba61abadef1	2024-02-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 088390 application number: ANDA088390

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
V13007Z41A	LIDOCAINE HYDROCHLORIDE	6108-05-0	LIDOCAINE HYDROCHLORIDE
30Q7KI53AK	EPINEPHRINE BITARTRATE	51-42-3	EPINEPHRINE BITARTRATE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
42756-1030-5	42756103005	50 CARTRIDGE in 1 CARTON (42756-1030-5) > 1.7 mL in 1 CARTRIDGE	50 cartridge	2011-11-07	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Lidocaine Hydrochloride and Epinephrine Bitartrate	IQ Dental \| Novocol Pharmaceutical of Canada, Inc.	2024-02-08	HUMAN PRESCRIPTION DRUG LABEL	4