Lidocaine

Product NDC: 42291-477
Requested package NDC: 42291-477-30
11-digit product format: 422910477
Labeler code: 42291
Product ID: 42291-477_485f641e-e708-998d-e063-6394a90adcd9
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Lidocaine
Dosage form: PATCH
Route: TOPICAL
Labeler: AvKARE
Application: ANDA206463
Marketing category: ANDA
Marketing start: 2023-11-16
Substance: LIDOCAINE
Active strength: 700 mg/1
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 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
A206463-001	LIDOCAINE	LIDOCAINE	5%	PATCH / TOPICAL	AB		2020-08-24

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A206463-001	AB

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	RLD / RS	Approval date	Source SHA-256
2026-08-01 22:54:32	2026-06	A206463-001	LIDOCAINE	5%	PATCH / TOPICAL	AB		2020-08-24	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-01 22:54:32	2026-06	A206463-001	AB	1	`a50c72e98297…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 10 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Lidocaine	LIDOCAINE	ASCLEMED USA INC.	56a54ef4-7aa0-e181-e063-6394a90a3e0e	2026-07-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206463 application number: ANDA206463
Lidocaine	LIDOCAINE	Preferred Pharmaceuticals Inc.	ebc05cf9-e82b-4f7d-b5e7-3e62025ce68c	2026-05-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206463 application number: ANDA206463
Lidocaine Patch	LIDOCAINE PATCH	Direct_Rx	eb503f1f-cd3a-ab76-e053-2995a90ab1c8	2026-03-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206463 application number: ANDA206463
Lidocaine	LIDOCAINE	Sportpharm LLC	1112681c-8de7-472b-8db4-2702054b835b	2026-02-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206463 application number: ANDA206463
Lidocaine	LIDOCAINE	A-S Medication Solutions	82bb7767-5407-4593-b6d4-90859890e376	2026-02-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206463 application number: ANDA206463
Lidocaine	LIDOCAINE	AvKARE	0a4cc4f8-9c5d-d03f-e063-6394a90a1b2e	2026-01-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206463 application number: ANDA206463 ndc (package): 42291-477-30 ndc (product): 42291-477 ndc11 (package): 42291047730
Lidocaine	LIDOCAINE	Advanced Rx Pharmacy of Tennessee, LLC	f94d388c-8471-885b-e053-6294a90ab67a	2024-12-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206463 application number: ANDA206463
Lidocaine	LIDOCAINE	Amneal Pharmaceuticals LLC	1f46bdfd-3a38-49a3-a505-0192790486d0	2024-10-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206463 application number: ANDA206463
Lidocaine	LIDOCAINE	Bryant Ranch Prepack	b4db5684-988f-44c4-a81e-5c04b8b0f6e7	2024-04-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206463 application number: ANDA206463
Lidocaine	LIDOCAINE	Bryant Ranch Prepack	19c585f3-e635-44d4-8eb0-14529eb34dca	2024-04-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206463 application number: ANDA206463

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
LIDOCAINE	700 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
98PI200987	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1745091	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
0a4cc4f8-9c5d-d03f-e063-6394a90a1b2e	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
070fbed5-7088-434a-a7ce-f2a64d8d40ac	Product name	2	20260107
bee66ce1-adb7-9d3b-67d9-582e4c54e80f	Product name	5	20250819
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
7d755fa1-1087-4dcd-98f0-6d4bba479a57	Product name	3	20210602
f52be47f-7aa7-46c0-b1fa-50c18dd50206	Product name	1	20201029
aed701d5-9c75-dfaf-7154-cde46179faea	Product name	9	20200313
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
49fa150c-f0de-cce7-3d9c-993ed81c5698	Product name	1	20140508
4d7ae718-ed00-bae8-2abe-9eaec1eef7ff	Product name	1	20140508
6084a4f4-5437-c9a5-caec-5361ee075a59	Product name	1	20140508
90c5639a-61b0-88d6-ddcf-21888e94869a	Product name	1	20140508
9137811f-f279-8640-5aeb-99fa2145d64d	Product name	1	20140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
42291-477-11	Lidocaine	1 in 1 POUCH	PATCH	1		2
42291-477-30	Lidocaine	30 in 1 BOX	PATCH	30		2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
42291-477-11	EA - Each	42291-477	ed204b7d-4fc7-4b7a-a78d-372923092cd8	1	2024-02-14
42291-477-30	EA - Each	42291-477	c1eec904-4071-447f-865c-70a1956e7310	1	2024-02-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
42291-477	LIDOCAINE PATCH [AVKARE]	1	Current NDC, 2 package rows	20231117_0a4cc4f8-9c5d-d03f-e063-6394a90a1b2e.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
98PI200987	LIDOCAINE	137-58-6	LIDOCAINE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1745091	lidocaine 5 % Medicated Patch	PSN	0a4cc4f8-9c5d-d03f-e063-6394a90a1b2e	2
1745091	lidocaine 0.05 MG/MG Medicated Patch	SCD	0a4cc4f8-9c5d-d03f-e063-6394a90a1b2e	2
1745091	lidocaine 5 % Medicated Patch	SY	0a4cc4f8-9c5d-d03f-e063-6394a90a1b2e	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
42291-477-30	42291047730	30 POUCH in 1 BOX (42291-477-30) / 1 PATCH in 1 POUCH (42291-477-11)	30 pouch	2023-11-16	No	No	Current