Cephalexin

Product NDC: 53217-299
11-digit product format: 532170299
Labeler code: 53217
Product ID: 53217-299_9bc61e1d-38ed-48a9-891d-3eb1490d46bd
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Cephalexin
Dosage form: CAPSULE
Route: ORAL
Labeler: Aidarex Pharmaceuticals LLC
Application: ANDA062702
Marketing category: ANDA
Marketing start: 1990-09-30
Marketing end: 0000-00-00
Substance: CEPHALEXIN
Active strength: 250 mg/1
Pharmacologic classes: Cephalosporin Antibacterial [EPC],Cephalosporins [CS]
NDC exclude flag: No
Listing certified through: 2019-12-31
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
53217-299-40	2020-01-31	C162847	48780-1	9d75b9d0-da08-f424-e053-dadaa90a57ce	These highlights do not include all the information needed to use CEPHALEXIN safely and effectively. See full prescribing information for CEPHALEXIN. CEPHALEXIN capsules, CEPHALEXIN for oral suspension, and CEPHALEXIN tablets, for oral use Initial U.S. Approval: 1971

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
53217-299-40	Cephalexin	40 in 1 BOTTLE	CAPSULE	40		2

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
53217-299-40	EA - Each	53217-299	e8a7c6fe-de9c-4497-a753-ea5048e67ae0	1	2017-06-15

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
53217-299	CEPHALEXIN CAPSULE [AIDAREX PHARMACEUTICALS LLC]	2	Legacy NDC, 1 package rows	20170519_eea0596f-26e4-4002-8bda-980890991c15.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
309112	cephalexin 250 MG Oral Capsule	PSN	eea0596f-26e4-4002-8bda-980890991c15	2
309112	cephalexin 250 MG Oral Capsule	SCD	eea0596f-26e4-4002-8bda-980890991c15	2
309112	cephalexin (as cephalexin monohydrate) 250 MG Oral Capsule	SY	eea0596f-26e4-4002-8bda-980890991c15	2

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
53217-299-40	53217029940	40 in 1 BOTTLE	Historical