Lidocaine and Prilocaine

Product NDC: 71589-017
11-digit product format: 715890017
Labeler code: 71589
Product ID: 71589-017_4dd55af9-cf3a-423f-83c1-85fa2dcfb971
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Lidocaine and Prilocaine
Dosage form: CREAM
Route: TOPICAL
Labeler: Aleor Dermaceuticals Limited
Application: ANDA213923
Marketing category: ANDA
Marketing start: 2022-04-12
Marketing end: 0000-00-00
Substance: LIDOCAINE; PRILOCAINE
Active strength: 25 mg/g; mg/g
Pharmacologic classes: Amide Local Anesthetic [EPC], Amide Local Anesthetic [EPC], Amides [CS], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE], Local Anesthesia [PE]
NDC exclude flag: No
Listing certified through: 2023-12-31
Current FDA listing: Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
71589-017-31	2025-03-04	C162847	48780-1	1030e364-fefc-111a-e063-dadaa90a10e2	d3380195-2f0c-4afd-9500-9e265429f67e
71589-017-31	2024-01-30	C162847	48780-1	1030e364-fefc-111a-e063-dadaa90a10e2	d3380195-2f0c-4afd-9500-9e265429f67e

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
98PI200987	LIDOCAINE	137-58-6	LIDOCAINE
046O35D44R	PRILOCAINE	721-50-6	PRILOCAINE

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
71589-017-31	71589001731	1 TUBE in 1 CARTON (71589-017-31) > 30 g in 1 TUBE	1 tube	2022-04-12	0000-00-00	No	No	Current