Levofloxacin

Product NDC: 12634-675
11-digit product format: 126340675
Labeler code: 12634
Product ID: 12634-675_2780a753-41fa-4f9b-e054-00144ff88e88
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Levofloxacin
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Apotheca Inc.
Application: ANDA200839
Marketing category: ANDA
Marketing start: 2012-03-22
Marketing end: 0000-00-00
Substance: LEVOFLOXACIN
Active strength: 500 mg/1
NDC exclude flag: E
Listing certified through: 2018-12-31
Current FDA listing: Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
addb5519-f7ae-4d4e-b9ca-f782a1597fd3	Product name	2	20210610
fb758c6a-fdee-40a8-99c2-46f79c3ff90c	Product name	4	20200807
1a81e9a9-11c3-4fcf-b5dd-f6798fef8e6d	Product name	1	20190618
aea4a616-4dfe-45f6-94bb-8b9063056ceb	Product name	6	20190611
2246ce8e-a477-4dc3-b6d6-fe9973c18ed1	Product name	1	20180821
5a6c788d-375b-4565-a8ae-67c179a30c93	Product name	1	20180212

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
12634-675-00	2020-01-31	C162847	48780-1	9d75b9d0-d6a8-f424-e053-dadaa90a57ce	HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use levofloxacin tablets, USP safely and effectively. See full prescribing information for levofloxacin tablets, USP. Levofloxacin Tablet, USP Film Coated for Oral use Initial U.S. Approval: 1996
12634-675-97	2020-01-31	C162847	48780-1	9d75b9d0-d6a8-f424-e053-dadaa90a57ce	HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use levofloxacin tablets, USP safely and effectively. See full prescribing information for levofloxacin tablets, USP. Levofloxacin Tablet, USP Film Coated for Oral use Initial U.S. Approval: 1996

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
12634-675-00	Levofloxacin	10 in 1 BOTTLE	TABLET, FILM COATED	10		1
12634-675-97	Levofloxacin	7 in 1 BOTTLE	TABLET, FILM COATED	7		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
12634-675	LEVOFLOXACIN TABLET, FILM COATED [APOTHECA INC.]	1	Legacy NDC, 2 package rows	20151222_2780a753-41f9-4f9b-e054-00144ff88e88.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
199885	levoFLOXacin 500 MG Oral Tablet	PSN	2780a753-41f9-4f9b-e054-00144ff88e88	1
199885	levofloxacin 500 MG Oral Tablet	SCD	2780a753-41f9-4f9b-e054-00144ff88e88	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
12634-675-00	12634067500	10 in 1 BOTTLE	Historical
12634-675-97	12634067597	7 in 1 BOTTLE	Historical