Lidocaine

Product NDC: 72189-488
11-digit product format: 721890488
Labeler code: 72189
Product ID: 72189-488_2c4e3760-8444-4adb-e063-6394a90a5ffc
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Lidocaine
Dosage form: OINTMENT
Route: TOPICAL
Labeler: Direct_Rx
Application: ANDA211697
Marketing category: ANDA
Marketing start: 2023-06-07
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: 2026-12-31
Current FDA listing: Yes

openFDA Listing Details

Product ID: 72189-488_2c4e3760-8444-4adb-e063-6394a90a5ffc
SPL ID: 2c4e3760-8444-4adb-e063-6394a90a5ffc
Product type: HUMAN PRESCRIPTION DRUG
Finished product: Yes
Brand name base: Lidocaine
Generic name: Lidocaine
Dosage form: OINTMENT
Route: TOPICAL
Marketing start: 2023-06-07
Marketing category: ANDA
Application number: ANDA211697
Pharmacologic classes: Amide Local Anesthetic [EPC]; Amides [CS]; Antiarrhythmic [EPC]; Local Anesthesia [PE]
Listing expiration: 2026-12-31

Ingredient	Strength
LIDOCAINE	50 mg/g

Package NDC	Description	Marketing start	Sample
72189-488-50	50 g in 1 CARTON (72189-488-50)	2023-06-07	No

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

Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
72189-488-50	72189048850	50 g in 1 CARTON (72189-488-50)	50 g	2023-06-07	No	No	Historical

Title	Manufacturer	Effective date	Type	Version
Lidocaine Ointment	Direct_Rx	2025-01-22	HUMAN PRESCRIPTION DRUG LABEL	2