Cephalexin

Product NDC: 50436-0219
11-digit product format: 504360219
Labeler code: 50436
Product ID: 50436-0219_144144d1-48a7-4623-9ce4-f3e516aaecca
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Cephalexin
Dosage form: CAPSULE
Route: ORAL
Labeler: Unit Dose Services
Application: ANDA090836
Marketing category: ANDA
Marketing start: 2011-01-19
Marketing end: 0000-00-00
Substance: CEPHALEXIN
Active strength: 500 mg/1
Pharmacologic classes: Cephalosporin Antibacterial [EPC],Cephalosporins [CS]
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
dfa3f520-409c-432e-b6d3-9250d468c772	Product name	1	20250401
64bb7f1a-2c2e-4741-8301-dbfeda7239f6	Product name	1	20190628
398aa563-bb78-fe0f-46a8-757c40ef28bf	Product name	1	20140508

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
50436-0219-2	2021-01-29	C162847	48780-1	ba0f9c33-5633-a910-e053-dadaa90a0b85	These highlights do not include all the information needed to use CEPHALEXIN CAPSULES safely and effectively. See full prescribing information for CEPHALEXIN CAPSULES. CEPHALEXIN capsules, for oral use Initial U.S. Approval: 1971

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
50436-0219-2	Cephalexin	20 in 1 BOTTLE	CAPSULE	20		2

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50436-0219	CEPHALEXIN CAPSULE [UNIT DOSE SERVICES]	2	Legacy NDC, 1 package rows	20180929_02806e6f-8746-4740-9327-ba58d320bff1.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
OBN7UDS42Y	CEPHALEXIN	23325-78-2	CEPHALEXIN

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
309114	cephalexin 500 MG Oral Capsule	PSN	02806e6f-8746-4740-9327-ba58d320bff1	2
309114	cephalexin 500 MG Oral Capsule	SCD	02806e6f-8746-4740-9327-ba58d320bff1	2
309114	cefalexin (as cefalexin monohydrate) 500 MG Oral Capsule	SY	02806e6f-8746-4740-9327-ba58d320bff1	2

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
50436-0219-2	50436021902	20 in 1 BOTTLE	Historical