Lidocaine Hydrochloride

Product NDC: 0904-7644
11-digit product format: 009047644
Labeler code: 0904
Product ID: 0904-7644_30c013e7-4df8-4692-8b8e-ba1466d15681
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Lidocaine Hydrochloride
Dosage form: SOLUTION
Route: ORAL
Labeler: Major Pharmaceuticals
Application: ANDA218138
Marketing category: ANDA
Marketing start: 2026-08-21
Substance: LIDOCAINE HYDROCHLORIDE
Active strength: 20 mg/mL
Pharmacologic classes: Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
A218138-001	LIDOCAINE HYDROCHLORIDE VISCOUS	LIDOCAINE HYDROCHLORIDE	2%	SOLUTION / ORAL	AT		2024-02-20

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A218138-001	AT

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
2026-10-15 13:18:30	2026-09	A218138-001	LIDOCAINE HYDROCHLORIDE VISCOUS	2%	SOLUTION / ORAL	AT	2024-02-20	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A218138-001	LIDOCAINE HYDROCHLORIDE VISCOUS	2%	SOLUTION / ORAL	AT	2024-02-20	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A218138-001	LIDOCAINE HYDROCHLORIDE VISCOUS	2%	SOLUTION / ORAL	AT	2024-02-20	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A218138-001	LIDOCAINE HYDROCHLORIDE VISCOUS	2%	SOLUTION / ORAL	AT	2024-02-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A218138-001	LIDOCAINE HYDROCHLORIDE VISCOUS	2%	SOLUTION / ORAL	AT	2024-02-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A218138-001	LIDOCAINE HYDROCHLORIDE VISCOUS	2%	SOLUTION / ORAL	AT	2024-02-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A218138-001	LIDOCAINE HYDROCHLORIDE VISCOUS	2%	SOLUTION / ORAL	AT	2024-02-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A218138-001	LIDOCAINE HYDROCHLORIDE VISCOUS	2%	SOLUTION / ORAL	AT	2024-02-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A218138-001	LIDOCAINE HYDROCHLORIDE VISCOUS	2%	SOLUTION / ORAL	AT	2024-02-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A218138-001	LIDOCAINE HYDROCHLORIDE VISCOUS	2%	SOLUTION / ORAL	AT	2024-02-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A218138-001	LIDOCAINE HYDROCHLORIDE VISCOUS	2%	SOLUTION / ORAL	AT	2024-02-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A218138-001	LIDOCAINE HYDROCHLORIDE VISCOUS	2%	SOLUTION / ORAL	AT	2024-02-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A218138-001	LIDOCAINE HYDROCHLORIDE VISCOUS	2%	SOLUTION / ORAL	AT	2024-02-20	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A218138-001	LIDOCAINE HYDROCHLORIDE VISCOUS	2%	SOLUTION / ORAL	AT	2024-02-20	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A218138-001	LIDOCAINE HYDROCHLORIDE VISCOUS	2%	SOLUTION / ORAL	AT	2024-02-20	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A218138-001	LIDOCAINE HYDROCHLORIDE VISCOUS	2%	SOLUTION / ORAL	AT	2024-02-20	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A218138-001	LIDOCAINE HYDROCHLORIDE VISCOUS	2%	SOLUTION / ORAL	AT	2024-02-20	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A218138-001	LIDOCAINE HYDROCHLORIDE VISCOUS	2%	SOLUTION / ORAL	AT	2024-02-20	`6a51e52b5d6a…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A218138-001	LIDOCAINE HYDROCHLORIDE VISCOUS	2%	SOLUTION / ORAL	AT	2024-02-20	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-10-15 13:18:30	2026-09	A218138-001	AT	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A218138-001	AT	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A218138-001	AT	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A218138-001	AT	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A218138-001	AT	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A218138-001	AT	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A218138-001	AT	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A218138-001	AT	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A218138-001	AT	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A218138-001	AT	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A218138-001	AT	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A218138-001	AT	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A218138-001	AT	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A218138-001	AT	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A218138-001	AT	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A218138-001	AT	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A218138-001	AT	1	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A218138-001	AT	1	`6a51e52b5d6a…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A218138-001	AT	1	`a50c72e98297…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product: Yes
Brand name base: Lidocaine Hydrochloride
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
LIDOCAINE HYDROCHLORIDE	20 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
V13007Z41A	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1010739	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
04e8dd94-93a8-427d-81ab-a95793d86c36	Available on FDA.report

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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Lidocaine Hydrochloride	LIDOCAINE HYDROCHLORIDE	Major Pharmaceuticals	04e8dd94-93a8-427d-81ab-a95793d86c36	2026-08-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 218138 application number: ANDA218138 ndc (product): 0904-7644
Lidocaine Hydrochloride	LIDOCAINE HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	abf60c5c-66df-4894-aa8f-bf770a6e9d00	2025-03-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 218138 application number: ANDA218138
Lidocaine Hydrochloride	LIDOCAINE HYDROCHLORIDE	PAI Holdings, LLC dba PAI Pharma	d5e23ede-957c-4a32-b1c6-268acb773c31	2025-01-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 218138 application number: ANDA218138

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
V13007Z41A	LIDOCAINE HYDROCHLORIDE	6108-05-0	LIDOCAINE HYDROCHLORIDE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
0904-7644-87	00904764487	4 TRAY in 1 CASE (0904-7644-87) / 10 CUP, UNIT-DOSE in 1 TRAY / 15 mL in 1 CUP, UNIT-DOSE (0904-7644-88)	4 tray	2026-08-21	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Lidocaine Hydrochloride Oral Topical Solution, USP 2% (Viscous) R x Only	Major Pharmaceuticals	2026-08-18	HUMAN PRESCRIPTION DRUG LABEL	1