NA

Product NDC: 83090-007
Requested package NDC: 83090-007-10
11-digit product format: 830900007
Labeler code: 83090
Product ID: 83090-007_eff2e41b-a181-2c76-e053-2995a90aa8b0
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Lidocaine Hydrochloride
Dosage form: INJECTION, SOLUTION
Route: RETROBULBAR
Labeler: Sintetica US LLC
Application: ANDA214269
Marketing category: ANDA
Marketing start: 2022-11-15
Marketing end: 0000-00-00
Substance: LIDOCAINE HYDROCHLORIDE ANHYDROUS
Active strength: 40 mg/mL
Pharmacologic classes: Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	83090-007	83090-007-10	I	Inactivated by FDA		2026-08-17

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A214269-001	LIDOCAINE HYDROCHLORIDE	LIDOCAINE HYDROCHLORIDE	4%	INJECTABLE / INJECTION	AP		2022-05-05

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A214269-001	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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A214269-001	LIDOCAINE HYDROCHLORIDE	4%	INJECTABLE / INJECTION	AP	2022-05-05	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A214269-001	LIDOCAINE HYDROCHLORIDE	4%	INJECTABLE / INJECTION	AP	2022-05-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214269-001	LIDOCAINE HYDROCHLORIDE	4%	INJECTABLE / INJECTION	AP	2022-05-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A214269-001	LIDOCAINE HYDROCHLORIDE	4%	INJECTABLE / INJECTION	AP	2022-05-05	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214269-001	LIDOCAINE HYDROCHLORIDE	4%	INJECTABLE / INJECTION	AP	2022-05-05	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214269-001	LIDOCAINE HYDROCHLORIDE	4%	INJECTABLE / INJECTION	AP	2022-05-05	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214269-001	LIDOCAINE HYDROCHLORIDE	4%	INJECTABLE / INJECTION	AP	2022-05-05	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214269-001	LIDOCAINE HYDROCHLORIDE	4%	INJECTABLE / INJECTION	AP	2022-05-05	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214269-001	LIDOCAINE HYDROCHLORIDE	4%	INJECTABLE / INJECTION	AP	2022-05-05	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214269-001	LIDOCAINE HYDROCHLORIDE	4%	INJECTABLE / INJECTION	AP	2022-05-05	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A214269-001	LIDOCAINE HYDROCHLORIDE	4%	INJECTABLE / INJECTION	AP	2022-05-05	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214269-001	LIDOCAINE HYDROCHLORIDE	4%	INJECTABLE / INJECTION	AP	2022-05-05	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214269-001	LIDOCAINE HYDROCHLORIDE	4%	INJECTABLE / INJECTION	AP	2022-05-05	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214269-001	LIDOCAINE HYDROCHLORIDE	4%	INJECTABLE / INJECTION	AP	2022-05-05	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A214269-001	LIDOCAINE HYDROCHLORIDE	4%	INJECTABLE / INJECTION	AP	2022-05-05	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A214269-001	LIDOCAINE HYDROCHLORIDE	4%	INJECTABLE / INJECTION	AP	2022-05-05	`5c6f7cd8ea54…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A214269-001	LIDOCAINE HYDROCHLORIDE	4%	INJECTABLE / INJECTION	AP	2022-05-05	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A214269-001	LIDOCAINE HYDROCHLORIDE	4%	INJECTABLE / INJECTION	AP	2022-05-05	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A214269-001	LIDOCAINE HYDROCHLORIDE	4%	INJECTABLE / INJECTION	AP	2022-05-05	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A214269-001	LIDOCAINE HYDROCHLORIDE	4%	INJECTABLE / INJECTION	AP	2022-05-05	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A214269-001	LIDOCAINE HYDROCHLORIDE	4%	INJECTABLE / INJECTION	AP	2022-05-05	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A214269-001	LIDOCAINE HYDROCHLORIDE	4%	INJECTABLE / INJECTION	AP	2022-05-05	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A214269-001	LIDOCAINE HYDROCHLORIDE	4%	INJECTABLE / INJECTION	AP	2022-05-05	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A214269-001	LIDOCAINE HYDROCHLORIDE	4%	INJECTABLE / INJECTION	AP	2022-05-05	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A214269-001	LIDOCAINE HYDROCHLORIDE	4%	INJECTABLE / INJECTION	AP	2022-05-05	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A214269-001	LIDOCAINE HYDROCHLORIDE	4%	INJECTABLE / INJECTION	AP	2022-05-05	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A214269-001	LIDOCAINE HYDROCHLORIDE	4%	INJECTABLE / INJECTION	AP	2022-05-05	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A214269-001	LIDOCAINE HYDROCHLORIDE	4%	INJECTABLE / INJECTION	AP	2022-05-05	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A214269-001	LIDOCAINE HYDROCHLORIDE	4%	INJECTABLE / INJECTION	AP	2022-05-05	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A214269-001	LIDOCAINE HYDROCHLORIDE	4%	INJECTABLE / INJECTION	AP	2022-05-05	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A214269-001	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A214269-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214269-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A214269-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214269-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214269-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214269-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214269-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214269-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214269-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A214269-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214269-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214269-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214269-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A214269-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A214269-001	AP	1	`5c6f7cd8ea54…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A214269-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A214269-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A214269-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A214269-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A214269-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A214269-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A214269-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A214269-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A214269-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A214269-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A214269-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A214269-001	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A214269-001	AP	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A214269-001	AP	1	`a50c72e98297…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
860a93dc-4863-49cc-b284-6bbe8191bc48	Product name	4	20250214
eaba870a-6a9d-442e-8643-87b3f558a451	Product name	1	20250117
9b4cf230-fd05-41d5-98c6-5db9ecb27b86	Product name	1	20230117
fa8b5901-e681-426f-82fe-54f6d81ec698	Product name	4	20180619
332d03e4-aa24-4b11-841a-02bf41081920	Product name	1	20171221
c08ab52f-2fc8-4409-9d9f-ed8edc0bd070	Product name	1	20171221
68ed98f8-24c2-44a0-944a-6d36e82ce25a	Product name	1	20141222
1cd42bc2-a430-c72b-636d-991b235fbf80	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
83090-007-01	NA	5 mL in 1 AMPULE	INJECTION, SOLUTION	5		1
83090-007-10	NA	10 in 1 CARTON	INJECTION, SOLUTION	10		1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
83090-007-10	ML - Milliliter	83090-007	aa8b19d3-c4e0-4c00-abc4-e39536a7baea	1	2024-03-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
83090-007	NA (LIDOCAINE HYDROCHLORIDE) INJECTION, SOLUTION [SINTETICA US LLC]	1	Legacy NDC, 2 package rows	20221217_a7529e5b-47b1-4148-98dd-65aecc33a8c3.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
EC2CNF7XFP	LIDOCAINE HYDROCHLORIDE ANHYDROUS	73-78-9	LIDOCAINE HYDROCHLORIDE ANHYDROUS
V13007Z41A	LIDOCAINE HYDROCHLORIDE	6108-05-0	Lidocaine Hydrochloride

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1010844	lidocaine HCl 4 % in 5 ML Injection	PSN	a7529e5b-47b1-4148-98dd-65aecc33a8c3	1
1010844	5 ML lidocaine hydrochloride 40 MG/ML Injection	SCD	a7529e5b-47b1-4148-98dd-65aecc33a8c3	1
1010844	lidocaine HCl 4 % per 5 ML Injection	SY	a7529e5b-47b1-4148-98dd-65aecc33a8c3	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
83090-007-10	83090000710	10 AMPULE in 1 CARTON (83090-007-10) > 5 mL in 1 AMPULE (83090-007-01)	10 ampule	2022-11-15	0000-00-00	No	No	Current

NA