Lidocaine

Product NDC: 71205-137
Requested package NDC: 71205-137-52
11-digit product format: 712050137
Labeler code: 71205
Product ID: 71205-137_d8a112aa-934b-45b2-a18c-6cbb5ffb162c
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Lidocaine
Dosage form: OINTMENT
Route: TOPICAL
Labeler: Proficient Rx LP
Application: ANDA206297
Marketing category: ANDA
Marketing start: 2016-08-15
Marketing end: 0000-00-00
Substance: LIDOCAINE
Active strength: 50 mg/g
Pharmacologic classes: Amide Local Anesthetic [EPC],Amides [CS],Antiarrhythmic [EPC],Local Anesthesia [PE]
NDC exclude flag: No
Listing certified through: 2020-12-31
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	71205-137	71205-137-52	D	Discontinued by firm		2026-07-31

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
A206297-001	LIDOCAINE	LIDOCAINE	5%	OINTMENT / TOPICAL	AT		2015-08-07

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A206297-001	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	RLD / RS	Approval date	Source SHA-256
2026-08-01 22:54:32	2026-06	A206297-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT		2015-08-07	`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	A206297-001	AT	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 · 7 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Lidocaine	LIDOCAINE	Preferred Pharmaceuticals Inc.	4806f94d-cbac-4107-b93b-8f715868ffb3	2026-05-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206297 application number: ANDA206297
Lidocaine	LIDOCAINE	PHOENIX RX LLC	40949067-a5a8-db8c-e063-6294a90af0fb	2026-02-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206297 application number: ANDA206297
Lidocaine	LIDOCAINE	Advanced Rx Pharmacy of Tennessee, LLC	f18b8413-8f52-a927-e053-2a95a90a402a	2024-12-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206297 application number: ANDA206297
Lidocaine	LIDOCAINE	Advanced Rx Pharmacy of Tennessee, LLC	f93cbde5-329a-f880-e053-6294a90a1af2	2024-12-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206297 application number: ANDA206297
Lidocaine	LIDOCAINE	Amneal Pharmaceuticals LLC	960f6d0a-82af-45e9-89d5-cea808004ebb	2024-10-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206297 application number: ANDA206297
Lidocaine	LIDOCAINE	Bryant Ranch Prepack	6fe7721d-42b3-4284-936b-a448ca530c45	2023-09-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206297 application number: ANDA206297
Lidocaine	LIDOCAINE	Amneal Pharmaceuticals LLC	d1509740-f9f1-44e3-8fde-51d8683fcd87	2018-10-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206297 application number: ANDA206297

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
71205-137-52	GM - Gram	71205-137	01969712-d4ac-4a9c-b468-79a89b4069b4	1	2018-12-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71205-137	LIDOCAINE OINTMENT [PROFICIENT RX LP]	3	Legacy NDC	20191022_5c32a824-8239-4776-99da-fe386017c174.zip

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
71205-137-52	71205013752	1 TUBE in 1 CARTON (71205-137-52) > 283.52 g in 1 TUBE	1 tube	2018-10-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Lidocaine Ointment USP, 5% FOR TOPICAL USEDO NOT USE IN THE EYES Rx Only	Proficient Rx LP	2019-10-01	HUMAN PRESCRIPTION DRUG LABEL	3