Levofloxacin

Product NDC: 50436-0022
11-digit product format: 504360022
Labeler code: 50436
Product ID: 50436-0022_9fce4392-db82-4386-bed5-e882faded707
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Levofloxacin
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Unit Dose Services
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: No
Listing certified through: 2020-12-31
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
50436-0022-1	2021-01-29	C162847	48780-1	ba0f9c33-556d-a910-e053-dadaa90a0b85	These highlights do not include all the information needed to use LEVOFLOXACIN TABLETS, safely and effectively. See full prescribing information for LEVOFLOXACIN TABLETS. LEVOFLOXACIN tablets, 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
50436-0022-1	Levofloxacin	10 in 1 BOTTLE	TABLET, FILM COATED	10		2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50436-0022-1	EA - Each	50436-0022	4f214f4f-6ab1-4d13-b54b-10b4a8f1d51c	1	2017-11-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50436-0022	LEVOFLOXACIN TABLET, FILM COATED [UNIT DOSE SERVICES]	2	Legacy NDC, 1 package rows	20171011_96a3d5ed-48c8-43fa-b93d-a03396d10c85.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
199885	levoFLOXacin 500 MG Oral Tablet	PSN	96a3d5ed-48c8-43fa-b93d-a03396d10c85	2
199885	levofloxacin 500 MG Oral Tablet	SCD	96a3d5ed-48c8-43fa-b93d-a03396d10c85	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
50436-0022-1	50436002201	10 in 1 BOTTLE	Historical