NA

Product NDC: 68055-643
Requested package NDC: 68055-643-10
11-digit product format: 680550643
Labeler code: 68055
Product ID: 68055-643_19b2a809-1a5b-472d-98c5-e5e8ef40bb87
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: LIDOCAINE HYDROCHLORIDE
Dosage form: INJECTION, SOLUTION
Route: INFILTRATION
Labeler: SINTETICA SA
Application: ANDA214267
Marketing category: ANDA
Marketing start: 2022-09-19
Marketing end: 0000-00-00
Substance: LIDOCAINE HYDROCHLORIDE ANHYDROUS
Active strength: 10 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#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

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	68055-643	68055-643-10	I	Inactivated by FDA		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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A214267-001	LIDOCAINE HYDROCHLORIDE	LIDOCAINE HYDROCHLORIDE	1%	INJECTABLE / INJECTION	AP		2022-09-19
A214267-002	LIDOCAINE HYDROCHLORIDE	LIDOCAINE HYDROCHLORIDE	2%	INJECTABLE / INJECTION	AP		2022-09-19

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A214267-001	AP
A214267-002	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 · 46 observed 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
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214267-001	LIDOCAINE HYDROCHLORIDE	1%	INJECTABLE / INJECTION	AP	2022-09-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214267-002	LIDOCAINE HYDROCHLORIDE	2%	INJECTABLE / INJECTION	AP	2022-09-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214267-001	LIDOCAINE HYDROCHLORIDE	1%	INJECTABLE / INJECTION	AP	2022-09-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214267-002	LIDOCAINE HYDROCHLORIDE	2%	INJECTABLE / INJECTION	AP	2022-09-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214267-001	LIDOCAINE HYDROCHLORIDE	1%	INJECTABLE / INJECTION	AP	2022-09-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214267-002	LIDOCAINE HYDROCHLORIDE	2%	INJECTABLE / INJECTION	AP	2022-09-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214267-001	LIDOCAINE HYDROCHLORIDE	1%	INJECTABLE / INJECTION	AP	2022-09-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214267-002	LIDOCAINE HYDROCHLORIDE	2%	INJECTABLE / INJECTION	AP	2022-09-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214267-001	LIDOCAINE HYDROCHLORIDE	1%	INJECTABLE / INJECTION	AP	2022-09-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214267-002	LIDOCAINE HYDROCHLORIDE	2%	INJECTABLE / INJECTION	AP	2022-09-19	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214267-001	LIDOCAINE HYDROCHLORIDE	1%	INJECTABLE / INJECTION	AP	2022-09-19	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214267-002	LIDOCAINE HYDROCHLORIDE	2%	INJECTABLE / INJECTION	AP	2022-09-19	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A214267-001	LIDOCAINE HYDROCHLORIDE	1%	INJECTABLE / INJECTION	AP	2022-09-19	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A214267-002	LIDOCAINE HYDROCHLORIDE	2%	INJECTABLE / INJECTION	AP	2022-09-19	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214267-001	LIDOCAINE HYDROCHLORIDE	1%	INJECTABLE / INJECTION	AP	2022-09-19	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214267-002	LIDOCAINE HYDROCHLORIDE	2%	INJECTABLE / INJECTION	AP	2022-09-19	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214267-001	LIDOCAINE HYDROCHLORIDE	1%	INJECTABLE / INJECTION	AP	2022-09-19	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214267-002	LIDOCAINE HYDROCHLORIDE	2%	INJECTABLE / INJECTION	AP	2022-09-19	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214267-001	LIDOCAINE HYDROCHLORIDE	1%	INJECTABLE / INJECTION	AP	2022-09-19	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214267-002	LIDOCAINE HYDROCHLORIDE	2%	INJECTABLE / INJECTION	AP	2022-09-19	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A214267-001	LIDOCAINE HYDROCHLORIDE	1%	INJECTABLE / INJECTION	AP	2022-09-19	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A214267-002	LIDOCAINE HYDROCHLORIDE	2%	INJECTABLE / INJECTION	AP	2022-09-19	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A214267-001	LIDOCAINE HYDROCHLORIDE	1%	INJECTABLE / INJECTION	AP	2022-09-19	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A214267-002	LIDOCAINE HYDROCHLORIDE	2%	INJECTABLE / INJECTION	AP	2022-09-19	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A214267-001	LIDOCAINE HYDROCHLORIDE	1%	INJECTABLE / INJECTION	AP	2022-09-19	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A214267-002	LIDOCAINE HYDROCHLORIDE	2%	INJECTABLE / INJECTION	AP	2022-09-19	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A214267-001	LIDOCAINE HYDROCHLORIDE	1%	INJECTABLE / INJECTION	AP	2022-09-19	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A214267-002	LIDOCAINE HYDROCHLORIDE	2%	INJECTABLE / INJECTION	AP	2022-09-19	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A214267-001	LIDOCAINE HYDROCHLORIDE	1%	INJECTABLE / INJECTION	AP	2022-09-19	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A214267-002	LIDOCAINE HYDROCHLORIDE	2%	INJECTABLE / INJECTION	AP	2022-09-19	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A214267-001	LIDOCAINE HYDROCHLORIDE	1%	INJECTABLE / INJECTION	AP	2022-09-19	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A214267-002	LIDOCAINE HYDROCHLORIDE	2%	INJECTABLE / INJECTION	AP	2022-09-19	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A214267-001	LIDOCAINE HYDROCHLORIDE	1%	INJECTABLE / INJECTION	AP	2022-09-19	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A214267-002	LIDOCAINE HYDROCHLORIDE	2%	INJECTABLE / INJECTION	AP	2022-09-19	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A214267-001	LIDOCAINE HYDROCHLORIDE	1%	INJECTABLE / INJECTION	AP	2022-09-19	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A214267-002	LIDOCAINE HYDROCHLORIDE	2%	INJECTABLE / INJECTION	AP	2022-09-19	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A214267-001	LIDOCAINE HYDROCHLORIDE	1%	INJECTABLE / INJECTION	AP	2022-09-19	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A214267-002	LIDOCAINE HYDROCHLORIDE	2%	INJECTABLE / INJECTION	AP	2022-09-19	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A214267-001	LIDOCAINE HYDROCHLORIDE	1%	INJECTABLE / INJECTION	AP	2022-09-19	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A214267-002	LIDOCAINE HYDROCHLORIDE	2%	INJECTABLE / INJECTION	AP	2022-09-19	`3bdfa0b2c4d7…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 46 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214267-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214267-002	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214267-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214267-002	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214267-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214267-002	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214267-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214267-002	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214267-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214267-002	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214267-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214267-002	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A214267-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A214267-002	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214267-001	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214267-002	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214267-001	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214267-002	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214267-001	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214267-002	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A214267-001	AP	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A214267-002	AP	1	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A214267-001	AP	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A214267-002	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A214267-001	AP	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A214267-002	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A214267-001	AP	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A214267-002	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A214267-001	AP	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A214267-002	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A214267-001	AP	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A214267-002	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A214267-001	AP	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A214267-002	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A214267-001	AP	1	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A214267-002	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A214267-001	AP	1	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A214267-002	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A214267-001	AP	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A214267-002	AP	1	`3bdfa0b2c4d7…`

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
68055-643-01	NA	10 mL in 1 AMPULE	INJECTION, SOLUTION	10		2
68055-643-10	NA	10 in 1 CARTON	INJECTION, SOLUTION	10		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68055-643	NA (LIDOCAINE HYDROCHLORIDE) INJECTION, SOLUTION [SINTETICA SA]	2	Legacy NDC, 2 package rows	20221004_cb3f71ce-bc8b-4f72-a155-92ab29f23833.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
1737570	lidocaine HCl 1 % in 10 ML Injection	PSN	cb3f71ce-bc8b-4f72-a155-92ab29f23833	2
1737568	lidocaine HCl 1 % in 2 ML Injection	PSN	cb3f71ce-bc8b-4f72-a155-92ab29f23833	2
1737566	lidocaine HCl 1 % in 5 ML Injection	PSN	cb3f71ce-bc8b-4f72-a155-92ab29f23833	2
1737763	lidocaine HCl 2 % in 10 ML Injection	PSN	cb3f71ce-bc8b-4f72-a155-92ab29f23833	2
1737757	lidocaine HCl 2 % in 2 ML Injection	PSN	cb3f71ce-bc8b-4f72-a155-92ab29f23833	2
1737761	lidocaine HCl 2 % in 5 ML Injection	PSN	cb3f71ce-bc8b-4f72-a155-92ab29f23833	2
1737570	10 ML lidocaine hydrochloride 10 MG/ML Injection	SCD	cb3f71ce-bc8b-4f72-a155-92ab29f23833	2
1737763	10 ML lidocaine hydrochloride 20 MG/ML Injection	SCD	cb3f71ce-bc8b-4f72-a155-92ab29f23833	2
1737568	2 ML lidocaine hydrochloride 10 MG/ML Injection	SCD	cb3f71ce-bc8b-4f72-a155-92ab29f23833	2
1737757	2 ML lidocaine hydrochloride 20 MG/ML Injection	SCD	cb3f71ce-bc8b-4f72-a155-92ab29f23833	2
1737566	5 ML lidocaine hydrochloride 10 MG/ML Injection	SCD	cb3f71ce-bc8b-4f72-a155-92ab29f23833	2
1737761	5 ML lidocaine hydrochloride 20 MG/ML Injection	SCD	cb3f71ce-bc8b-4f72-a155-92ab29f23833	2
1737570	lidocaine HCl 1 % in 10 ML Injection	SY	cb3f71ce-bc8b-4f72-a155-92ab29f23833	2
1737568	lidocaine HCl 1 % per 2 ML Injection	SY	cb3f71ce-bc8b-4f72-a155-92ab29f23833	2
1737566	lidocaine HCl 1 % per 5 ML Injection	SY	cb3f71ce-bc8b-4f72-a155-92ab29f23833	2
1737570	lidocaine HCl 100 MG per 10 ML Injection	SY	cb3f71ce-bc8b-4f72-a155-92ab29f23833	2
1737761	lidocaine HCl 100 MG per 5 ML Injection	SY	cb3f71ce-bc8b-4f72-a155-92ab29f23833	2
1737763	lidocaine HCl 2 % per 10 ML Injection	SY	cb3f71ce-bc8b-4f72-a155-92ab29f23833	2
1737757	lidocaine HCl 2 % per 2 ML Injection	SY	cb3f71ce-bc8b-4f72-a155-92ab29f23833	2
1737761	lidocaine HCl 2 % per 5 ML Injection	SY	cb3f71ce-bc8b-4f72-a155-92ab29f23833	2
1737568	lidocaine HCl 20 MG per 2 ML Injection	SY	cb3f71ce-bc8b-4f72-a155-92ab29f23833	2
1737763	lidocaine HCl 200 MG per 10 ML Injection	SY	cb3f71ce-bc8b-4f72-a155-92ab29f23833	2
1737757	lidocaine HCl 40 MG per 2 ML Injection	SY	cb3f71ce-bc8b-4f72-a155-92ab29f23833	2
1737566	lidocaine HCl 50 MG per 5 ML Injection	SY	cb3f71ce-bc8b-4f72-a155-92ab29f23833	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68055-643-10	68055064310	10 AMPULE in 1 CARTON (68055-643-10) > 10 mL in 1 AMPULE (68055-643-01)	10 ampule	2022-09-19	0000-00-00	No	No	Current

NA